Clinical trials appendix

Q2 2021 results update Movement since Q1 2021 update

New to Phase I New to Phase II New to Pivotal trial New to registration

NME NME NME AZD1402# AZD2816¶# (next generation COVID-19 vaccine) tezepelumab# NAVIGATOR [US, EU & JP] 1 Inhaled IL4Ra asthma SARS-CoV-2 prevention of COVID-19 TSLP mAb severe, uncontrolled asthma

AZD9977 + Farxiga Additional indication Lifecycle management # MCR + SGLT2 inhibitor heart failure with CKD capivasertib + fulvestrant + palbociclib CAPItello-292 Fasenra# OSTRO [US] 1 AKT inhibitor + fulvestrant + CDK4/6 inhibitor 1st- line triplet in early IL5R mAb nasal polyps zibotentan + Farxiga3 ZENITH-CKD relapse/ET resistant locally advanced (inoperable) or metastatic breast cancer ETA antagonist + SGLT2 CKD Lifecycle Management Enhertu# DESTINY-Breast09 HER2 targeting antibody drug conjugate 1st-line HER2-postitive breast cancer

Enhertu# DESTINY-Gastric04 HER2 targeting antibody drug conjugate 2nd-line HER2-positive gastric cancer

Lokelma DIALIZE-Outcomes potassium binder CV outcomes in patients on chronic hemodialysis with hyperkalemia

tezepelumab# WAYPOINT TSLP mAb nasal polyposis

Removed from Phase I Removed from Phase II Removed from Phase III Removed from registration

Additional indication Lifecycle management Lifecycle management Imfinzi + Lynparza# BAYOU Lynparza# SOLO-3 Farxiga3 DAPA-CKD [US] 2 PD-L1 mAb + PARP inhibitor 1st-line unresectable PARP inhibitor gBRCA PSR ovarian cancer SGLT2 inhibitor renal outcomes and CV mortality in stage IV bladder cancer patients with CKD

tezepelumab# TSLP mAb atopic dermatitis

Phase progressions based on first patient dose achievement. 1 Submission accepted 2 Approved 3 Farxiga in the US; Forxiga in ROW 2 ¶ Registrational Phase II/III trial # Partnered and/or in collaboration Q2 2021 new molecular entity (NME)1 pipeline

Phase I Phase II Phase III 16 New Molecular Entities 18 New Molecular Entities 13 New Molecular Entities

adavosertib# AZD0466# Imfinzi#+RT (platform) CLOVER Imfinzi#+imaradenant#+cabazitaxel camizestrant+palbociclib SERENA-4 Imfinzi#+tremelimumab+SoC NILE Wee1 ovarian / uterine serous / solid BCL2/xL haematological tumours PD-L1+RT HNSCC NSCLC SCLC PD-L1+A2aR+CTx prostate cancer SERD+CDK4/6 1L HR+ HER2- breast cancer PD-L1+CTLA-4+SoC 1L urothelial cancer tumours

AZD1390 Imfinzi+selumetinib# AZD2811 nanoparticle Imfinzi#+monalizumab# capivasertib#+abiraterone CAPItello-281 Lynparza#+Imfinzi# DuO-E ATM glioblastoma PD-L1+MEK solid tumours Aurora B solid tumours PD-L1+NKG2a solid tumours AKT+abiraterone PTEN deficient mHSPC PARP+PD-L1 1L endometrial cancer

AZD4573 IPH5201# camizestrant (AZD9833) Imfinzi#+Lynparza# ORION capivasertib#+chemo CAPItello-290 Lynparza#+Imfinzi#+bevacizumab DuO-O CDK9 haematological malignancies CD39 solid tumours SERD ER+ breast PD-L1+PARP 1L mNSCLC AKT+chemotherapy mTNBC 1L PARP+PD-L1+VEGF 1L ovarian

capivasertib#+fulvestrant+palbociclib monalizumab#+cetuximab (INTERLINK-1) AZD5305 MEDI1191 capivasertib# Imfinzi#+MEDI0457# CAPItello-292 NKG2a+EGFR 2L+ relapsed metastatic PARP1Sel solid tumours IL12 mRNA solid tumours AKT prostate PD-L1+DNA HPV vaccine HNSCC AKT+fulvestrant+CDK4/6 HR+ breast 1L HNSCC

Imfinzi+FOLFOX+bevacizumab (platform) capivasertib#+fulvestrant CAPItello-291 AZD5991 MEDI5395 ceralasertib COLUMBIA1 PD-L1 + chemo + VEGF + AKT+fulvestrant locally-advanced MCL1 haematological malignancies rNDV GMCSF solid tumours ATR solid tumours multiple novel ONC therapies 1L MSS-CRC (inoperable) or metastatic breast

AZD7648# MEDI5752+lenvatinib Imfinzi (platform) HUDSON datopotamab deruxtecan# MEDI5752 Under Review DNAPK solid and haematological PD-1/CTLA-4+VEGF advanced renal PD-L1+multiple novel ONC therapies post TROPION-Lung01 TROP2 2L+ NSCLC PD-1/CTLA-4 solid tumours tumours cell carcinoma IO NSCLC without actionable mutation 0 New Molecular Entities Imfinzi# (platform) BALTIC oleclumab+chemo or AZD8701# MEDI9253 Imfinzi#+/-tremelimumab+chemo POSEIDON PD-L1+CTLA-4, WEE1+Carboplatin, Imfinzi#+oleclumab+chemo FOXP3 solid tumours rNDV IL12 solid tumours PD-L1+/-CTLA-4+SoC 1L NSCLC ATR+PARP ES-SCLC R/R CD73+chemo or PD-L1+CD73+chemo

Tagrisso combo# TATTON Imfinzi# (platform) COAST Post-1L Tagrisso (platform) ORCHARD Imfinzi#+adavosertib# Imfinzi#+/-tremelimumab+CRT ADRIATIC EGFR+MEK/MET advanced EGFRm PD-L1+multiple novel ONC therapies EGFR+multiple novel ONC therapies PD-L1+Wee1 solid tumours PD-L1+/-CTLA-4+CRT LS-SCLC NSCLC NSCLC EGFRm NSCLC

Imfinzi# (platform) NeoCOAST Imfinzi#+tremelimumab HIMALAYA PD-L1+multiple novel ONC therapies Tagrisso+savolitinib# SAVANNAH EGFR+MET advanced EGFRm NSCLC PD-L1+CTLA-4 1L HCC NSCLC

Phase progressions based on first patient dose achievement. 1 Includes novel combinations and additional indications for assets where the lead is not yet launched. 3 # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial Oncology Precision medicine approach being explored Q2 2021 new molecular entity (NME)1 pipeline

Phase I Phase II Phase III Under Review 11 New Molecular Entities 22 New Molecular Entities 6 New Molecular Entities 2 New Molecular Entities

cotadutide AZD2816¶# next generation COVID-19 AZD0284 anifrolumab# anifrolumab# TULIP GLP-1/glucagon T2D / obesity / NASH / vaccine SARS-CoV-2 prevention of RORg psoriasis / respiratory Type I IFN receptor lupus nephritis Type I IFN receptor SLE DKD COVID-19

AZD7442 AZD0449 anifrolumab# MEDI3506 tezepelumab# NAVIGATOR long-acting antibody combination Inhaled JAK inhibitor asthma Type I IFN receptor SLE SC IL-33 diabetic kidney disease TSLP severe uncontrolled asthma COVID-19

AZD2373 AZD1402# MEDI3506 brazikumab¶ Podocyte health nephropathy inhaled IL-4Ra asthma IL-33 AD / COPD / asthma / COVID-19 IL23 crohns disease

nirsevimab# AZD2693 AZD4831 MEDI5884# RSV mAb-YTE passive RSV nonalcoholic steatohepatitis MPO HFpEF cholesterol modulation cardiovascular immunisation

AZD3366 AZD5718 MEDI6570 PT027# CD39L3 CV disease FLAP coronary artery disease / CKD LOX-1 CV disease ICS/SABA asthma

MEDI7352 AZD3427 AZD7986# tezepelumab# WAYPOINT NGF/TNF OA pain / painful diabetic Relaxin ThP CV disease DPP1 COPD TSLP nasal polyps neuropathy

AZD4041# AZD8233 navafenterol# orexin 1 receptor antagonist opioid use hypercholesterolemia cardiovascular MABA COPD disorder

MEDI0618# AZD8601# suvratoxumab PAR2 antagonist mAb osteooarthritis VEGF-A cardiovascular α-Toxin Staphylococcus pneumonia pain

MEDI1341# AZD9567 tezepelumab# COURSE alpha synuclein parkinson's disease SGRM chronic inflammatory diseases TSLP COPD

MEDI1814# AZD9977+Farxiga verinurad amyloidβ alzheimer's disease MCR+SGLT2 HF with CKD URAT-1 CKD / HFpEF

MEDI8367 brazikumab zibotentan+Farxiga ZENITH-CKD avb8 chronic kidney disease IL23 ulcerative colitis ETA antagonist+SGLT2 CKD

Phase progressions based on first patient dose achievement. 1 Includes novel combinations and additional indications for assets where the lead is not yet launched 4 # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial BioPharmaceuticals Precision medicine approach being explored Q2 2021 lifecycle management (LCM)1 pipeline

Phase I Phase II Phase III Under Review 1 Projects 9 Projects 31 Projects 0 Projects

Imfinzi# CALLA Enhertu# (platform) DESTINY-Breast08 Enhertu# (platform) DESTINY-Breast07 Calquence# Imfinzi#+CTx TOPAZ-1 PD-L1 adj. locally-advanced cervical ADC breast ADC breast BTK inhibitor 1st line MCL PD-L1+CTx 1L biliary tract cancer cancer

Imfinzi#+FLOT MATTERHORN Enhertu# DESTINY-CRC-01 Calquence# Imfinzi# PEARL PD-L1+CTx neo-adjuvant/adjuvant gastic ADC colorectal cancer BTK inhibitor r/r CLL, high risk PD-L1 1L metastatic NSCLC cancer

Enhertu# DESTINY-Gastric02 Calquence#+venetoclax+obinutuzumab Imfinzi# post-SBRT PACIFIC-4 Imfinzi#+VEGF EMERALD-2 ADC gastric BTK+BCL-2+anti-CD20 1st line CLL PD-L1 post-SBRT stage I/II NSCLC PD-L1+VEGF adjuvant HCC

Imfinzi# POTOMAC Enhertu# DESTINY-Lung01 Calquence+R-CHOP ESCALADE Imfinzi#+VEGF+TACE EMERALD-1 PD-L1 non muscle invasive bladder ADC NSCLC BTK+R-CHOP 1L DLBCL PD-L1+VEGF+TACE locoregional HCC cancer

Enhertu# DESTINY-PanTumor01 Imfinzi#+CRT KUNLUN Lynparza# LYNK-003 Enhertu# DESTINY-Breast02 HER2 targeting ADC HER2-expressing PD-L1+CRT locally-advanced esophageal PARP platinum sensitive 1L colorectal ADC breast solid tumours squamous cell carcinoma cancer

Enhertu# DESTINY-PanTumor02 Enhertu# DESTINY-Breast03 Imfinzi#+CRT PACIFIC-2 Lynparza# OlympiA HER2 targeting ADC HER2-expressing ADC breast PD-L1+CRT NSCLC PARP gBRCA adjuvant breast solid tumours

Imfinzi#+CRT PACIFIC-5 (China) Imfinzi# (platform) BEGONIA Enhertu# DESTINY-Breast04 Lynparza+abiraterone# PROpel PD-L1+CRT locally-advanced stage III PD-L1 1L mTNBC ADC breast PARP+NHA prostate cancer NSCLC

Tagrisso LAURA Imfinzi# (platform) MAGELLAN Enhertu# DESTINY-Breast05 Imfinzi#+Ctx MERMAID-1 EGFRm locally-advanced unresectable PD-L1 1L mNSCLC ADC breast PD-L1 stage II-III adjuvant NSCLC NSCLC

Lynparza# (basket) MK-7339-002 / Imfinzi#+CTx neoadjuvant AEGEAN Tagrisso+/-CTx neoadjuvant Enhertu# DESTINY-Breast06 LYNK002 PD-L1+CTx locally-advanced stage II-III NeoADAURA EGFR+/-CTx stage II/III ADC breast PARP HRRm cancer NSCLC resectable EGFRm NSCLC

Enhertu# DESTINY-Breast09 Imfinzi#+CTx NIAGARA Tagrisso+chemo FLAURA2 HER2 targeting ADC HER2+ breast PD-L1+CTx muscle invasive bladder EGFR+chemo 1L adv EGFRm NSCLC cancer 1L cancer

Enhertu# DESTINY-Gastric04 HER2 targeting ADC HER2+ gastric cancer 2L

Phase progressions based on first patient dose achievement. 1 Includes significant LCM projects and parallel indications for assets beyond Phase III 5 # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial Oncology Precision medicine approach being explored Q2 2021 lifecycle management (LCM)1 pipeline

Phase I Phase II Phase III Under Review 0 Projects 3 Projects 10 Projects 1 Project

Fasenra ARROYO Breztri Fasenra NATRON Fasenra# OSTRO IL-5R chronic spontaneous urticaria LABA/LAMA/ICS asthma IL-5R hypereosinophilic syndrome IL-5R nasal polyps

Farxiga/Forxiga DAPA-MI Fasenra HILLIER Fasenra# RESOLUTE SGLT2 prevention of HF and CV death IL-5R atopic dermatitis IL-5R COPD following a myocardial infarction

Lokelma DIALIZE-Outcomes roxadustat# Farxiga/Forxiga DELIVER potassium binder CV outcomes in patients HIF-PH inhibitor chemo induced anaemia SGLT2 HFpEF on chronic hemodialysis with hyperkalemia

Fasenra FJORD roxadustat# IL-5R bullous pemphigoid HIFPH anaemia MDS

Fasenra MANDARA IL-5R EGPA

Fasenra MESSINA IL-5R eosinophilic esophagitis

Phase progressions based on first patient dose achievement. 1 Includes significant LCM projects and parallel indications for assets beyond Phase III 6 # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial BioPharmaceuticals Precision medicine approach being explored Estimated key regulatory submission acceptances

camizestrant + palbociclib breast cancer SERENA-4 capivasertb + abiraterone PTEN deficient Imfinzi + tremelimumab + CRT mHSPC CAPItello-281 LDS-SCLC ADRIATIC nirsevimab capivasertb + CTx 1L mTNBC Imfinzi + tremelimumab + SoC urothelial passive RSV immunisation CAPItello-290 NILE capivasertib + fulvestrant 2L locally advanced Lynparza + Imfinzi endometrial cancer brazikumab crohns disease AZD7442 SARS-CoV-2 PT027 asthma or mBC CAPItello-291 DUO-E INTREPID COVID-19 Vaccine AstraZeneca Imfinzi + tremelimumab HCC capivasertib + fulvestrant + palbociclib 1L Lynparza +Imfinzi + bevacizumab ovarian Fasenra

SARS-CoV-2 (US) HIMALAYA locally advanced or mBC CAPItello-292 DUO-O severe asthma (China) NME Imfinzi +/- tremelimumab NSCLC Koselugo NF1 (China / Japan) datopotamab deruxtecan NSCLC monalizumab + cetuximab tezepelumab nasal polyposis POSEIDON SPRINT TROPION-Lung01 2L+ relapsed mHNSCC INTERLINK-1 WAYPOINT H2 2021 H1 2022 H2 2022 2022+

Calquence r/r CLL, high risk Calquence 1L CLL Enhertu Calquence + R-CHOP 1L DLBCL Imfinzi + CRT LA ESCC Duaklir Genuair COPD (China) ELEVATE-RR ELEVATE-TN (China) DESTINY-Breast02 ESCALADE KUNLUN Enhertu Enhertu Imfinzi cervical Calquence + venetoclax + Imfinzi + CRT neo-adjuvant/adjuvant gastric Farxiga prevention of HF and CV death DESTINY-Breast03 DESTINY-Breast04 CALLA obinutuzumab 1L CLL AMPLIFY MATTERHORN following a myocardial infarction DAPA-MI

LCM Lynparza breast Imfinzi + CRT NSCLC Imfinzi NSCLC Calquence 1L MCL Imfinzi + CTx stage II-III adjuvant NSCLC Fasenra bullous pemphigoid OLYMPIA PACIFIC-2 PEARL ECHO MERMAID-1 FJORD Lynparza + abiraterone prostate Farxiga HF (HFpEF) Imfinzi + CTx biliary tract Enhertu Imfinzi + chemo muscle invasive bladder Breztri/Trixeo asthma PROPEL DELIVER TOPAZ-1 DESTINY-Breast05 NIAGARA KALOS, LOGOS Xigduo XR/Xigduo Fasenra eosinophilic esophagitis Enhertu Imfinzi post-SBRT NSCLC Fasenra EGPA type-2 diabetes (China) MESSINA DESTINY-Breast06 PACIFIC-4 MANDARA Enhertu Imfinzi + CRT NSCLC Fasenra HES roxadustat anemia in MDS DESTINY-Breast09 PACIFIC-5 (China) NATRON Enhertu Imfinzi non muscle invasive bladder Fasenra nasal polyps DESTINY-Gastric04 POTOMAC ORCHID (China / Japan) Imfinzi neoadjuvant NSCLC Tagrisso + CTx EGFRm NSCLC Fasenra COPD AEGEAN FLAURA2 RESOLUTE Imfinzi adjuvant NSCLC Tagrisso locally adv. unresectable NSCLC Lokelma BR.31 LAURA DIALIZE-Outcomes Imfinzi + VEGF + TACE locoregional HCC Lynparza platinum sensitive 1L colorectal EMERALD-1 LYNK-003 Note. NME section includes novel combinations and additional indications for assets where the lead is not yet launched Imfinzi + VEGF adjuvant HCC Tagrisso stage II/III resectable EGFRm EMERALD-2 NSCLC NeoADAURA

7 Oncology BioPharmaceuticals Designations 5 18 12 36 29 Accelerated approvals Breakthrough / PRIME1 / Sakigake2 Fast Track Priority Review Orphan

ACCELERATED APPROVAL, these regulations allowed medicines for serious conditions that addressed an unmet medical need to be approved based on a surrogate endpoint.

BREAKTHROUGH DESIGNATION is a process designed to expedite the development and review of medicines which may demonstrate substantial improvement over available therapy. 1PRIME is a scheme launched by the EMA to enhance support for the development of medicines that target an unmet medical need. 2SAKIGAKE is aimed at early introduction of innovative medicines, medical devices, etc. that are initially developed in Japan.

FAST TRACK is a process designed to facilitate the development, and expedite the review of medicines to treat serious conditions and fill an unmet medical need. PRIORITY REVIEW DESIGNATION is the US FDA’s goal to take action on an application within 6 months.

ORPHAN DRUG DESIGNATION, intended for treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 patients in the US, or that affect more than 200,000 patients but are not expected to recover the costs of developing and marketing a treatment drug.

8 Oncology BioPharmaceuticals Oncology – approved medicines and late-stage pipeline Approved medicines Late-stage development Tagrisso (highly-selective, irreversible EGFRi) Early development NSCLC Oncology

Trial Population Patients Design Endpoints Status Phase III Adjuvant EGFRm NSCLC 682 • Arm 1: Tagrisso QD following complete tumour resection, • Primary endpoint: DFS • FPCD: Q4 2015 ADAURA with or without chemo • Secondary endpoints: DFS Rate, OS, • LPCD: Q1 2019 NCT02511106 • Arm 2: placebo OS Rate, QoL • Data readout: Q2 2020 Global trial - 25 countries • Trial unblinded due to efficacy CVRM • DFS primary endpoint met

Phase III Maintenance therapy in patients with 200 • Arm 1: Tagrisso • Primary endpoint: PFS (BICR) • FPCD: Q4 2018 LAURA locally advanced, unresectable EGFRm • Arm 2: placebo • Secondary endpoints: CNS PFS, OS, • Data anticipated: 2022+ NCT03521154 Stage III NSCLC whose disease has not Global trial - 17 countries DoR, ORR, DCR progressed following platinum-based chemoradiation

therapy R&I

Phase III Real world setting in adult patients with 3020 • Single-arm trial - Tagrisso • Primary endpoints: OS and safety • FPCD: Q3 2015 ASTRIS advanced or metastatic, EGFRm Global trial - 16 countries • Secondary endpoint: PFS • LPCD: Q4 2017 NCT02474355 T790M+ NSCLC

Phase II EGFR TKI treatment-naïve patients with 150 • Single arm trial - Tagrisso • Primary Endpoint: proportion of • FPCD: Q2 2018 ELIOS locally-advanced or metastatic EGFRm Global trial - five countries patients with a given tumour genetic

NCT03239340 NSCLC and proteomic marker at the point of Other disease progression as defined by the investigator • Secondary endpoints: PFS, ORR, DoR Phase I Patients with EGFRm NSCLC with brain 8 • Single-arm trial - Tagrisso • Primary Endpoints: assessments of • FPCD: Q4 2018

ODIN-BM metastases brain standard uptake value (SUV) and • LPCD: Q1 2020 19

NCT03463525 pharmacokinetics (PK) • Data anticipated: H2 2021 -

• Secondary endpoint: PK COVID

10 Approved medicines Late-stage development Tagrisso (highly-selective, irreversible EGFRi) Early development NSCLC, combinations Oncology

Trial Population Patients Design Endpoints Status Phase III Neoadjuvant EGFRm NSCLC 351 • Arm 1: placebo plus pemetrexed/carboplatin or • Primary endpoint: mPR • FPCD Q1 2021 NeoADAURA pemetrexed/cisplatin • Secondary endpoints cPR, EFS, DFS, OS • Data anticipated: 2022+ NCT04351555 • Arm 2: Tagrisso plus pemetrexed/carboplatin or pemetrexed/cisplatin CVRM • Arm 3: Tagrisso Global trial – 23 countries

Phase III 1st-line EGFRm NSCLC 586 • Arm 1: Tagrisso plus pemetrexed/carboplatin or • Primary endpoint: PFS • FPCD: Q4 2019 FLAURA2 pemetrexed/cisplatin • Secondary endpoints: OS, LOS, ORR • Data anticipated: 2022+ NCT04035486 • Arm 2: Tagrisso DoR, Depth of response, PFS2. QoL, PK

Global trial – 23 countries R&I

Phase II EGFRm / MET+, locally 259 • Single arm trial: Tagrisso + Orpathys • Primary endpoint: ORR • FPCD Q1 2019 SAVANNAH advanced or metastatic Global trial • Secondary endpoints include PFS, DoR • Data anticipated: 2022+ NCT03778229 NSCLC who have progressed and OS following treatment with

Tagrisso Other Phase II Advanced EGFRm NSCLC 182 Modular design platform trial: • Primary endpoint: ORR • FPCD: Q3 2019 ORCHARD patients who have • Module 1: Tagrisso + Orpathys (cMET) • Secondary endpoints: PFS, DoR, OS, • Data anticipated: 2022+ NCT03944772 progressed on first line • Module 2: Tagrisso + gefitinib (EGFRm) safety and tolerability Tagrisso treatment • Module 3: Tagrisso + necitumumab (EGFRm) • Module 4: carboplatin + pemetrexed + Imfinzi

• Module 5: Tagrisso + alectinib (ALK) 19

• Module 6: Tagrisso + selpercatinib (RET fusion) - • No intervention: observational cohort

Global trial - 8 countries COVID

11 Approved medicines Late-stage development Imfinzi (PD-L1 mAb) Early development NSCLC, early disease Oncology

Trial Population Patients Design Endpoints Status Phase III Completely resected 332 • Arm 1: Imfinzi + SoC chemo • Primary endpoint: DFS • FPCD: Q3 2020 MERMAID-1 Stage II and III NSCLC • Arm 2: placebo + SoC chemo • Secondary endpoints: DFS, OS • Data anticipated: 2022+

NCT04385368 CVRM Phase III Completely resected 284 • Arm 1: Imfinzi • Primary endpoint: DFS • FPCD: Q4 2020 MERMAID-2 Stage II-III NSCLC • Arm 2: placebo • Secondary endpoints: DFS, PFS, OS • Data anticipated: 2022+ NCT04642469 Phase III Neoadjuvant NSCLC patients 800 • Arm 1: Imfinzi + platinum-based chemo • Primary endpoints: pCR, EFS • FPCD: Q1 2019 AEGEAN Stage II and III resected NSCLC • Arm 2: placebo + platinum-based chemo • Secondary endpoint: mPR • Data anticipated: 2022+ NCT03800134 (incl. EGFR/ALK positive)

Phase III Adjuvant NSCLC patients 1360 • Arm 1: Imfinzi mg/kg i.v. Q4W x 12m • Primary endpoint: DFS • FPCD: Q1 2015 R&I ADJUVANT BR.31 Ib (≥4cm) – stage IIIa resected NSCLC • Arm 2: placebo • Secondary endpoint: OS • LPCD: Q1 2020 NCT02273375 (incl. EGFR/ALK positive) Global trial • Data anticipated: 2022+ Partnered

Phase III Unresected, locally-advanced NSCLC 300 • Arm 1: Imfinzi i.v. Q4W + chemo/RT • Primary endpoint: PFS • FPCD: Q2 2018 PACIFIC-2 • Arm 2: placebo + chemo/RT • Secondary endpoints: OS, ORR • LPCD: Q3 2019 NCT03519971 ex US global trial • Data anticipated: H2 2021 Phase III Imfinzi with SBRT in unresected, 630 • Arm 1: Imfinzi i.v. Q4W with definitive SBRT • Primary endpoint: PFS • FPCD: Q2 2019 PACIFIC-4 Stage I/II NSCLC • Arm 2: placebo with definitive SBRT • Secondary endpoint: OS • Data anticipated: 2022+ NCT03833154 Other

Phase III Unresected, locally-advanced NSCLC 360 • Arm 1: Imfinzi i.v. Q4W following chemo/RT • Primary endpoint: PFS • FPCD: Q1 2019 PACIFIC-5 • Arm 2: placebo following chemo/RT • Secondary endpoint: OS • Data anticipated: 2022+

NCT03706690 ex US global trial, China focus

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12 Approved medicines Late-stage development Imfinzi (PD-L1 mAb) Early development Lung cancer, early disease Oncology

Trial Population Patients Design Endpoints Status Phase II NSCLC, patients who 340 Open-label, biomarker-directed, multicentre trial • Primary outcome: ORR • FPCD: Q1 2018 HUDSON progressed on an • Module 1: Imfinzi and Lynparza • Secondary outcomes: efficacy including • Data anticipated: 2022+ NCT03334617 anti-PD-1/PD-L1 • Module 2: Imfinzi and danvatirsen OS, PFS, DCR, and safety and tolerability, containing therapy • Module 3: Imfinzi and ceralasertib (AZD6738) DoR CVRM • Module 4: Imfinzi and vistusertib • Module 5: Imfinzi and oleclumab • Module 6: Imfinzi and Enhertu • Module 7: Imfinzi and cediranib • Module 8: ceralasertib Phase II Stage III NSCLC 189 • Arm A: Imfinzi • Primary endpoint: OR per RECIST v1.1 • FPCD: Q4 2018 COAST unresectable • Arm B: Imfinzi + oleclumab • Data anticipated: H2 2021 NCT03822351 • Arm C: Imfinzi + monalizumab R&I Phase II Resectable, early- 84 • Arm A: Imfinzi • Primary endpoint: Major pathological • FPCD: Q1 2019 NeoCOAST stage NSCLC • Arm B: Imfinzi + oleclumab response rate • Data anticipated: H2 2021 NCT03794544 • Arm C: Imfinzi + monalizumab • Arm D: Imfinzi + danvatirsen

Phase I/II NSCLC 124 Open-label, multicentre study to evaluate the safety, • Primary endpoints: PK, safety • FPCD: Q2 2021

SCope-D1 SCLC pharmacokinetics, and preliminary efficacy of subcutaneous Imfinzi • Data anticipated: 2022+

Other

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13 Approved medicines Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development Lung cancer, advanced disease Oncology

Trial Population Patients Design Endpoints Status Phase III NSCLC 1L 650 • Arm 1: Imfinzi Q4W • Primary endpoint: OS • FPCD: Q1 2017 PEARL • Arm 2: chemotherapy • LPCD: Q1 2019 • NCT03003962 Asia trial Data anticipated: H1 2022 CVRM

Phase III NSCLC 1L 1000 • Arm 1: Imfinzi + chemo • Primary endpoints: OS, PFS • FPCD: Q2 2017 POSEIDON • Arm 2: Imfinzi + tremelimumab + chemo • LPCD: Q4 2018 NCT03164616 • Arm 3: SoC • Data readout: Q4 2019 • PFS primary endpoint met • OS data readout: Q2 2021 Phase II/III Lung Master Stage IV squamous NSCLC 140 • Subtrial A: Imfinzi (non-match for other biomarker driven subtrials) i.v. • Primary endpoints: ORR, PFS, OS • FPCD: Q2 2014

Protocol patients Q2W single arm Imfinzi Phase II only • Data anticipated: 2022+ R&I NCT02154490 • Subtrial B: PI3K inhibitor vs. docetaxel Partnered Biomarker-targeted • Subtrial C: CDK4/6 inhibitor vs. docetaxel 2L therapy • Subtrial D: AZD4547 (FGFR inhibitor) vs. docetaxel • Subtrial E: cMET/HGFR Inhibitor + erlotinib vs. erlotinib Phase II NSCLC 1L 212 • Arm A1: Imfinzi • Primary endpoints: safety & • FPCD: Q1 2019 MAGELLAN • Arm A2: Imfinzi + danvatirsen tolerability • Data anticipated: 2022+ NCT03819465 • Arm A3: Imfinzi + oleclumab • Secondary endpoints: ORR, DoR, PFS, • Arm A3: MEDI5752 OS, PK, ADA • Arm B1: Imfinzi + Investigator's choice of chemo • Arm B2: Imfinzi + danvatirsen + Investigator's choice of chemo Other • Arm B3: Imfinzi + oleclumab + Investigator's choice of chemo • Arm B4: MEDI5752 Phase Ib NSCLC 459 Dose escalation: • Primary endpoints: safety, Optimal • FPCD: Q4 2013 Study 006 (IO naïve and IO pretreated • Minimum 5 cohorts exploring various treme Q4W and Imfinzi i.v. Q4W biologic dose for the combination, OR • LPCD: Q4 2016

NCT02000947 patient cohorts) dose combinations, higher dose levels and alternate Q2 schedule • Secondary endpoints include: • Data readout: Q3 2020 19 - added with amendment antitumour activity, PK and Dose expansion: immunogenicity • MTD for the combination in escalation to be explored in expansion

North American, EU and ROW trial centres COVID

14 Approved medicines Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development SCLC, advanced disease Oncology

Trial Population Patients Design Endpoints Status Phase III Limited stage SCLC 1L 600 • Arm 1: Imfinzi + tremelimumab (4 doses) • Primary endpoints: PFS, OS • FPCD: Q4 2018 ADRIATIC following platinum-based • Arm 2: Imfinzi • Data anticipated: H2 2022 • NCT03703297 concurrent chemoradiation Arm 3: placebo CVRM therapy Phase III Extensive stage SCLC 1L 805 • Arm 1: Imfinzi + tremelimumab + EP (carboplatin or cisplatin • Primary endpoint: OS • FPCD: Q1 2017 CASPIAN + etoposide) • LPCD: Q2 2018 NCT03043872 • Arm 2: Imfinzi + EP (carboplatin or cisplatin + etoposide) • Data readout: Q2 2019 • Arm 3: EP (carboplatin or cisplatin + etoposide) • OS Primary endpoint met for Imfinzi monotherapy • OS primary endpoint not met for

Imfinzi + tremelimumab R&I Phase II SCLC 72 • Arm A: Imfinzi + tremelimumab Q4W • Primary endpoint: ORR • FPCD: Q4 2016 BALTIC • Arm B: adavosertib and carboplatin BID • Data anticipated: H2 2021

NCT02937818 • Arm C: ceralasertib and Lynparza

Other

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15 Approved medicines Late-stage development Imfinzi (PD-L1 mAb) Early development Other cancers, early disease Oncology

Trial Population Patients Design Endpoints Status Phase III Non-muscle invasive bladder 1018 • Arm 1: BCG (Induction + maintenance) • Primary endpoint: DFS • FPCD: Q2 2018 POTOMAC cancer • Arm 2: Imfinzi + BCG (Induction only) • LPCD: Q432020

NCT03528694 • Arm 3: Imfinzi + BCG (Induction + maintenance) • Data anticipated: 2022+ CVRM

Phase III Muscle-invasive bladder 1050 • Arm 1: Imfinzi in combination with gemcitabine + cisplatin, • Coprimary endpoints: pCR , EFS • FPCD: Q4 2018 NIAGARA cancer Imfinzi maintenance • LPCD: Q3 2021 NCT03732677 • Arm 2: gemcitabine + cisplatin • Data anticipated: 2022+ Phase III Locoregional HCC 710 • Arm 1: TACE in combination with Imfinzi • Primary endpoint: PFS for Arm 1 vs • FPCD: Q1 2019 EMERALD-1 • Arm 2: TACE in combination with Imfinzi + bevacizumab Arm 3 • LPCD: Q3 2021 NCT03778957 • Arm 3: TACE in combination with placebo • Secondary endpoint: PFS for Arm 2 vs • Data anticipated: H2 2022

Arm 3 , OS R&I Phase III Adjuvant therapy in HCC 888 • Arm 1: Imfinzi + bevacizumab • Primary endpoint: RFS for Arm 2 vs • FPCD: Q2 2019 EMERALD-2 • Arm 2: Imfinzi + placebo Arm 3 • Data anticipated: 2022+ NCT03847428 • Arm 3: placebo + placebo • Secondary endpoints: RFS Arm 1 vs Arm 3, OS, RFS at 24m Phase III Locally advanced, 600 • Arm 1: Imfinzi + definitive CRT • Primary endpoint: PFS • FPCD: Q4 2020 KUNLUN unresectable ESCC • Arm 2: placebo + definitive CRT • Secondary endpoint: OS • Data anticipated: 2022+ NCT04550260

Phase III Resectable GC/GEJC 900 • Arm 1: Imfinzi + FLOT • Primary endpoint: EFS • FPCD: Q4 2020 Other MATTERHORN • Arm 2: placebo + FLOT • Secondary endpoints: OS Arm 1 vs Arm • Data anticipated: 2022+ NCT04592913 2, pCR Arm 1 vs Arm 2

Phase Ib/II 1L metastatic MSS-CRC 112 • Part 1 S1 FOLFOX + bevacizumab + Imfinzi + oleclumab • Primary endpoints: • FPCD: Q3 2019

COLUMBIA 1 • Part 1: safety • Data anticipated: 2022+ 19

• Part 2 Control 1 FOLFOX + bevacizumab - NCT04068610 • Part 2 E1 FOLFOX + bevacizumab + Imfinzi + oleclumab • Part 2: efficacy (OR) • Secondary endpoints: • Part 1: efficacy (OR), BOR, DoR, PFS • Part 2: safety and efficacy (BOR, COVID DoR, DC, PFS, OS)

16 Approved medicines Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development Other cancers, advanced disease Oncology

Trial Population Patients Design Endpoints Status Phase III Bladder cancer 1L 1215 • Arm 1: Imfinzi + tremelimumab + SoC • Primary endpoint: OS • FPCD: Q4 2018 NILE • Arm 2: Imfinzi + SoC • LPCD: Q2 2021

NCT03682068 • Arm 3: SoC • Data anticipated: 2022+ CVRM

Phase III HCC 1L 1324 • Arm 1: Imfinzi + tremelimumab • Primary endpoint: OS • FPCD: Q4 2017 HIMALAYA • Arm 2: Imfinzi • Secondary endpoints: PFS, TTP, ORR • LPCD: Q4 2019 NCT03298451 • Arm 3: sorafenib • Data anticipated: H2 2021

Phase III BTC 1L 757 • Arm 1: Imfinzi + gemcitabine + cisplatin • Primary endpoint: OS • FPCD Q2 2019 TOPAZ-1 • Arm 2: placebo + gemcitabine + cisplatin • Secondary endpoints: PFS, ORR, DoR • LPCD: Q4 2020

NCT03875235 Global trial • Data anticipated: H2 2022 R&I Phase II Urothelial bladder cancer 76 • Arm 1: tremelimumab (urothelial bladder cancer) • Primary endpoint: ORR • FPCD: Q4 2015 NCT02527434 triple-negative breast cancer • Arm 2: tremelimumab (triple-negative breast cancer) • Secondary endpoints: safety, DoR • LPCD: Q4 2016 pancreatic ductal- • Arm 3: tremelimumab (pancreatic ductal-adenocarcinoma) • Data readout: Q4 2018 adenocarcinoma Phase III Locally advanced cervical 714 • Arm 1 Imfinzi + EBRT + brachytherapy with platinum • Primary endpoint: PFS • FPCD: Q1 2019 CALLA cancer • Arm 2 placebo + EBRT + brachytherapy with platinum • Secondary endpoints: OS, CR rate, • LPCD: Q4 2020 NCT03830866 Global trial DoR, ORR, safety/tolerability • Data anticipated: H1 2022

Phase Ib/II Hepatocellular carcinoma 545 • Arm A: Imfinzi + tremelimumab • Primary endpoints: safety & • FPCD: Q4 2015 Other Study 22 • Arm B: Imfinzi 2L tolerability, DLTs • Data anticipated: H2 2020 NCT02519348 • Arm C: tremelimumab 2L • Secondary endpoints: ORR, DoR, OS • Arm D: Imfinzi + tremelimumab

• Arm E: Imfinzi in combination with bevacizumab

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17 Approved medicines Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development Other cancers, advanced disease Oncology

Trial Population Patients Design Endpoints Status Phase III Advanced solid malignancies 1200 • Arm 1: Imfinzi • Primary endpoint: safety • FPCD: Q2 2017 STRONG • Arm 2: Imfinzi + tremelimumab • Data anticipated: 2022+

NCT03084471 CVRM Phase II mTNBC 1L 220 • Arm 1 Imfinzi + paclitaxel • Primary endpoints: safety and • FPCD: Q1 2019 BEGONIA • Arm 2 Imfinzi + paclitaxel + capivasertib tolerability • Data anticipated: 2022+ NCT03742102 • Arm 4 Imfinzi + paclitaxel + danvatirsen • Secondary endpoints: ORR, PFS, DoR, • Arm 5 Imfinzi + paclitaxel + oleclumab OS, PK, ADA • Arm 6 Imfinzi + Enhertu • Arm 7 Imfinzi + datopotamab deruxtecan

Global trial R&I Phase I/II Solid tumours 1022 Dose escalation: 5 cohorts at Q2W and 1 cohort at Q3W • Primary endpoints: safety, optimal • FPCD: Q3 2012 Study 1108 Dose expansion: 16 tumour type cohorts at the Q2W MTD biologic dose • LPCD: Q4 2016 NCT01693562 defined during dose escalation • Secondary endpoints include: PK, • Data readout: Q2 2020 Dose exploration: cohort at 20mg Q4W immunogenicity and antitumour Global trial - nine countries activity

Phase I HNSCC, NSCLC, SCLC 167 Imfinzi +/- treme in combination with chemoradiation in • Primary endpoint: safety • FPCD: Q2 2018 CLOVER advanced solid tumours • Data anticipated: H2 2021 NCT03509012 • HNSCC Arm 1 Other • NSCLC Arm 1 • NSCLC Arm 2 • NSCLC Arm 3 • SCLC Arm 2 • SCLC Arm 3

• SCLC Arm 4 19

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18 Approved medicines Late-stage development Lynparza (PARP inhibitor) Early development Multiple cancers Oncology

Trial Population Patients Design Endpoints Status Phase III BRCAm adjuvant breast 1836 • Arm 1: Lynparza BID 12-month duration • Primary endpoint: invasive disease- • FPCD: Q2 2014 OlympiA cancer • Arm 2: placebo 12-month duration free survival (iDFS) • LPCD: Q2 2019 NCT02032823 Global trial partnership with Breast International Group and • Secondary endpoint: distant disease- • Data readout: Q1 2021

Partnered National Cancer Institute/NRG Oncology free survival and OS • Primary endpoint met CVRM

R&I

Other

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19 Approved medicines Late-stage development Lynparza (PARP inhibitor) Early development Other combinations Oncology

Trial Population Patients Design Endpoints Status Phase III Metastatic castration- 904 • Arm 1: Lynparza + abiraterone • Primary Endpoint: rPFS • FPCD: Q4 2018 PROpel resistant prostate cancer 1L • Arm 2: placebo + abiraterone • Secondary endpoints: TFST, TTPP, OS • FPCD: Q2 2020

NCT03732820 Global trial • Data anticipated: H2 2021 CVRM Phase III Advanced colorectal cancer 525 • Arm 1: bevacizumab + 5-FU maintenance • Primary endpoint: PFS • FPCD: Q3 2020 LYNK-003 1L maintenance • Arm 2: bevacizumab + Lynparza maintenance • Secondary endpoints: OS, ORR, DoR, • Data anticipated: 2022+ NCT04456699 • Arm 3: Lynparza maintenance AEs Partnered Global trial

Phase II/III Recurrent platinum 680 • Arm 1: chemo • Primary endpoints: PFS, OS • FPCD: Q2 2016 GY005 resistant/refractory ovarian • Arm 2: cediranib + Lynparza • Secondary endpoints: ORR, QoL, • Data anticipated: 2022+

NCT02502266 cancer • Arm 3: cediranib safety R&I Externally sponsored • Arm 4: Lynparza US, Canada

Phase II HRRm or HRD-positive 390 • Arm 1: Lynparza • Primary endpoints: ORR • FPCD: Q1 2019 LYNK-002 advanced cancer Global trial • Secondary endpoints: DOR, OS, PFS, NCT03742895 AE, Prog by CA-125

Partnered

Other

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20 Approved medicines Late-stage development Lynparza (PARP inhibitor) Early development Imfinzi combinations Oncology

Trial Population Patients Design Endpoints Status Phase III Advanced ovarian cancer 1L 1,256 Non tBRCAm (tumour BRCA) patients • Primary endpoint: PFS • FPCD: Q1 2019 DuO-O • Arm 1: bevacizumab • Secondary endpoints: OS, PFS2 • Data anticipated: 2022+ NCT03737643 • Arm 2: bevacizumab + Imfinzi • Arm 3: bevacizumab + Imfinzi + Lynparza CVRM tBRCAm patients • bevacizumab (optional) + Imfinzi + Lynparza Global trial Phase III Advanced and recurrent 699 • Arm 1: chemo + Imfinzi placebo followed by Imfinzi placebo • Primary endpoint PFS • FPCD: Q2 2020 DuO-E endometrial cancer 1L and Lynparza placebo • Secondary endpoints: OS, PFS2, ORR, • Data anticipated: 2022+ NCT04269200 • Arm 2: chemo + Imfinzi followed by Imfinzi + Lynparza DoR placebo • Arm 3: chemo + Imfinzi followed by Imfinzi + Lynparza R&I Global Trial Phase II Stage IV NSCLC whose disease has 250 • Arm 1: Imfinzi + Lynparza • Primary endpoint: PFS • FPCD Q1 2019 ORION not progressed following SoC chemo • Arm 2: Imfinzi + placebo • Secondary endpoints: OS, ORR, DoR, • Data readout: Q2 2021 NCT03775486 + Imfinzi Maintenance therapy 1L Global trial PFS in HRRm, PK, ADA

Phase II Platinum-Ineligible unresectable 154 • Arm 1: Imfinzi + Lynparza • Primary endpoint: PFS • FPCD: Q2 2018

BAYOU Stage IV urothelial cancer • Arm 2: Imfinzi + placebo • Secondary endpoints: OS, DoR, ORR, • LPCD: Q3 2019 Other NCT03459846 Global trial PFS in HRRm, PFS6, PK, ADA, PRO • Data readout : Q2 2021

Phase I / II gBRCAm ovarian cancer 2L+ 148 Dose until progression • Primary endpoints: DCR at 12 weeks, • FPCD: Q2 2016 MEDIOLA gBRCAm HER2-negative breast • Arm 1: Lynparza + Imfinzi safety and tolerability • LPCD: Q2 2017 NCT02734004 cancer 1-3L Global trial

SCLC 2L+ 19 - Gastric cancer 2L+ Phase I / II gBRCAm ovarian cancer 2L+ 115 Dose until progression • Primary endpoints: DCR at 12 weeks, • FPCD: Q2 2018 MEDIOLA Non-gBRCAm ovarian cancer 2L+ • Arm 1: Lynparza + Imfinzi ORR, safety and tolerability • LPCD: Q2 2020

(Ovarian expansion) Non-gBRCAm ovarian cancer 2L+ • Arm 2: Lynparza + Imfinzi COVID NCT02734004 • Arm 3: Lynparza + Imfinzi + bevacizumab Global trial

21 Approved medicines Late-stage development Enhertu (trastuzumab deruxtecan, HER2 ADC) Early development Breast cancer Oncology

Trial Population Patients Design Endpoints Status Phase III HER2-positive, unresectable and/or 600 Randomised open label parallel assignment • Primacy endpoint: PFS • FPCD: Q3 2018 DESTINY-Breast02 metastatic breast cancer pretreated • Enhertu • Secondary endpoints: OS, ORR, DoR, • LPCD: Q4 2020 NCT03523585 with prior standard of care HER2 • Physicians choice of lapatinib + capecitabine or trastuzumab CBR • Data anticipated: H2 2022 therapies, including trastuzumab + capecitabine CVRM emtansine Phase III HER2-positive, unresectable and/or 500 Randomised open label parallel assignment • Primary endpoint: PFS • FPCD: Q3 2018 DESTINY-Breast03 metastatic breast cancer previously • Enhertu • Secondary endpoints: OS, ORR, DoR, • LPCD: Q2 2020 NCT03529110 treated with trastuzumab and taxane • Ado-trastuzumab emtansine CBR • Data anticipated: H2 2021 Phase III HER2-low, unresectable and/or 540 Randomised open label parallel assignment • Primary end point: PFS • FPCD: Q4 2018 DESTINY-Breast04 metastatic breast cancer patients • Enhertu • Secondary end points: OS, DoR, ORR • LPCD: Q4 2020

NCT03734029 • Physicians choice of SoC chemo (choice of capecitabine, • Data anticipated: H1 2022 R&I eribulin, gemcitabine, paclitaxel or nab-paclitaxel) Phase III High-risk HER2-positive patients with 1,600 Randomised open label parallel assignment • Primary endpoint: IDFS • FPCD: Q4 2020 DESTINY-Breast05 residual invasive breast cancer following • Enhertu • Secondary endpoints: DFS, OS, DRFI, • Data anticipated: 2022+ NCT04622319 neoadjuvant therapy • Ado-trastuzumab emtansine BMFI Phase III HER2-Low, HR+ breast cancer patients 850 Randomised open label parallel assignment • Primary endpoint: PFS • FPCD Q3 2020 DESTINY-Breast06 whose disease has progressed on • Enhertu • Secondary endpoints: OS, DoR, ORR • Data anticipated: 2022+ NCT04494425 endocrine therapy in the metastatic • Investigator's choice standard of care chemotherapy

setting (capecitabine, paclitaxel, nab-paclitaxel) Other Phase III HER2-positive, metastatic breast cancer, 1134 Randomised, parallel assignment • Primary endpoint: PFS • FPCD: Q2 2021 DESTINY-Breast09 no prior therapy for advanced or • Enhertu + placebo • Secondary endpoints: OS, DoR, ORR • Data anticipated: 2022+ NCT04784715 metastatic disease • Enhertu + pertuzumab

• Standard of Care

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22 Approved medicines Late-stage development Enhertu (trastuzumab deruxtecan, HER2 ADC) Early development Breast cancer Oncology

Trial Population Patients Design Endpoints Status Phase Ib/II HER2-positive metastatic breast cancer 350 Randomised open label sequential assignment • Primary endpoints: AE, SAE • FPCD: Q1 2021 DESTINY-Breast07 • Enhertu • Secondary endpoints: ORR, PFS, DoR, • Data anticipated: 2022+ NCT04538742 • Enhertu + Imfinzi OS

• Enhertu + pertuzumab CVRM • Enhertu + paclitaxel • Enhertu + Imfinzi + paclitaxel • Enhertu + tucatinib Phase Ib HER2-low metastatic breast cancer 185 Non-Randomised open label parallel assignment • Primary endpoints: AE, SAE • FPCD: Q1 2021 DESTINY-Breast08 • Enhertu + capecitabine • Secondary endpoints: ORR, PFS, DoR, • Data anticipated: 2022+ NCT04556773 • Enhertu + Imfinzi + paclitaxel OS • Enhertu + capivasertib

• Enhertu + anastrozole R&I

• Enhertu + Faslodex

Other

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23 Approved medicines Late-stage development Enhertu (trastuzumab deruxtecan, HER2 ADC) Early development Gastric cancer Oncology

Trial Population Patients Design Endpoints Status Phase III HER2-positive gastric cancer or gastro- 490 Open label randomised parallel group assignment • Primary endpoint: OS • FPCD: Q2 2021 DESTINY-Gastric04 esophageal junction adenocarcinoma • Enhertu • Secondary endpoints: ORR, DoR, PFS, • Data anticipated: 2022+ NCT04704934 patients who have progressed on or • SoC chemo DcR, safety after a trastuzumab-containing regimen CVRM and have not received any additional systemic therapy Phase II HER2-overexpressing advanced gastric 233 Randomised open label parallel assignment • Primary endpoint: ORR • FPCD: Q4 2017 DESTINY-Gastric01 or gastroeosophogeal junction • Enhertu • Secondary endpoints: PFS, OS, DoR, • LPCD: Q2 2019 NCT03329690 adenocarcinoma patients who have • SoC chemo DCR, TTF, range of PK endpoints • Data readout: Q1 2020 progressed on two prior treatment • Two additional open label patient cohorts with lower levels • Primary endpoint met regimens of HER2 expression

Japan and Korea R&I Phase II HER2-positive gastric cancer that cannot 79 Open label single group assignment • Primary endpoint: ORR • FPCD: Q4 2019 DESTINY-Gastric02 be surgically removed or has spread • Enhertu • Secondary endpoints: PFS, ORR, OS, • LPCD: Q4 2020 NCT04014075 Western population DoR • Data anticipated: H2 2021

Phase Ib/II HER2-overexpressing gastric or 250 Open label parallel assignment • Part 1 Primary endpoint: safety • FPCD: Q2 2020 DESTINY-Gastric03 gastroeosophogeal junction cancer Part 1: To determine recommended Phase II combination dose • Part 2 Primary endpoint: ORR NCT04379596 patients • 5 Arms combine Enhertu with standard of care • Secondary end points: DoR, DCR, PFS, chemotherapies (5-FU, capecitabine, oxaliplatin) and / or OS, range of PK endpoints, ADAs durvalumab Other Part 2: To assess efficacy of the selected combinations • Arm 2A: Standard chemotherapy (control) • Arm 2B: Enhertu monotherapy • Arm 2C: Enhertu with chemotherapy

• Arm 2D: Enhertu with chemotherapy and durvalumab 19

Global trial 8 countries - COVID

24 Approved medicines Late-stage development Enhertu (trastuzumab deruxtecan, HER2 ADC) Early development Other cancers Oncology

Trial Population Patients Design Endpoints Status Phase II HER2-over-expressing or mutated, 170 Non randomised parallel group assignment • Primary endpoint: ORR • FPCD: Q2 2018 DESTINY-Lung01 unresectable and/or metastatic NSCLC • Enhertu • Secondary endpoints: DoR, PFS, OS • Data anticipated: H2 2021

NCT03505710 CVRM

Phase II HER2-Mutated, Unresectable and/or 150 Randomised parallel group assignment • Primary endpoint: ORR • FPCD: Q1 2021 DESTINY-Lung02 Metastatic NSCLC • Arm 1: Enhertu 6.4 mg/kg • Secondary endpoints: DoR, DCR, PFS, NCT04644237 • Arm 2: Enhertu 5.4mg/kg OS, PK

Phase Ib HER2-over-expressing, unresectable 120 Non randomised parallel group assignment • Primary endpoint: safety • Initiating R&I DESTINY-Lung03 and/or metastatic NSCLC • Arm 1: Enhertu + cisplatin + Imfinzi • Secondary endpoints: ORR, DoR, DCR, NCT04686305 • Arm 2: Enhertu + carboplatin + Imfinzi PFS, OS, range of PK endpoints • Arm 3: Enhertu + pemetrexed + Imfinzi

• Arm 4: Enhertu + Imfinzi

Other

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25 Approved medicines Late-stage development Enhertu (trastuzumab deruxtecan, HER2 ADC) Early development Other cancers Oncology

Trial Population Patients Design Endpoints Status Phase II HER2 expressing tumours 280 Non randomised single group assignment • Primary endpoint: ORR • FPCD: Q4 2020 DESTINY-PanTumour02 • Enhertu • Secondary endpoints: DoR, DCR, PFS,

NCT04482309 OS CVRM

Phase II HER2m expressing tumours 100 Non-randomised single group assignment • Primary endpoint: ORR • FPCD: Q1 2021 DESTINY-PanTumour01 • Enhertu • Secondary endpoints: DoR, DCR, PFS, NCT04639219 PK

Phase II HER2-overexpressing advanced or 120 Randomised parallel group assignment • Primary endpoint: ORR • FPCD: Q1 2021

DESTINY-CRC02 metastatic colorectal cancer • Arm 1: Enhertu 6.4 mg/kg • Secondary endpoint: PFS, OS, DoR, R&I NCT04744831 • Arm 2: Enhertu 5.4mg/kg range of PK endpoints

Phase I Advanced solid malignant tumours 278 Non randomised single group assignment • Primary endpoints: ORR, number of • FPCD: Q3 2015 J101 • Enhertu subjects with AEs, tumour response • Data readout: Q3 2018 NCT02564900 • Secondary endpoints PK

Phase I HER2-expressing locally 115 Non randomised parallel group assignment • Primary endpoints: DLT, ORR • FPCD: Q2 2020

U106 advanced/metastatic breast or NSCLC • Enhertu + pembrolizumab • Secondary endpoints: DoR, DCR, PFS, Other NCT04042701 Global trial 2 countries TTR, OS

Phase I HER2-expressing breast and urothelial 99 Non randomised sequential assignment • Primary endpoints: DLT, ORR, TEAEs • FPCD: Q3 2018

U105 cancer • Enhertu + nivolumab • Secondary endpoints: DoR, DCR, PFS, • Data anticipated H2 2021 19

NCT03523572 Global trial 7 countries TTR, OS, ORR (investigator) - COVID

26 Approved medicines Late-stage development Calquence (BTK inhibitor) Early development Blood cancers Oncology

Trial Population Patients Design Endpoint(s) Status Phase III Previously untreated CLL 535 • Arm A: chlorambucil + obinutuzumab • Primary endpoint: PFS (Arm A vs. Arm • FPCD: Q2 2015 ACE-CL-007 (ELEVATE-TN) • Arm B: Calquence + obinutuzumab B) • Data readout: Q2 2019 NCT02475681 • Arm C: Calquence • Secondary endpoints: IRC • Primary endpoint met (independent review committee) CVRM assessed ORR, OS (Arm A vs. Arm B vs. Arm C)

Phase III Previously untreated CLL 780 • Arm A; Calquence + venetoclax • Primary endpoint: IRC PFS (A vs C) • FPCD: Q1 2019 ACE-CL-311 fit • Arm B: Calquence + venetoclax + obinutuzumab • Secondary endpoint: IRC PFS (B vs C); • Data anticipated: 2022+ NCT03836261 • Arm C: FCR or BR INV PFS (A vs C; B vs C)

Phase III Relapsed/refractory CLL 306 • Arm A: Calquence • Primary endpoint: IRC assessed PFS • FPCD Q3 2016 ACE-CL-309 (ASCEND) • Arm B: rituximab + idelalisib or bendamustine (Arm A vs. Arm B) • Data readout: Q2 2019 R&I NCT02970318 (investigator’s choice) • Secondary endpoints: INV-assessed • Primary endpoint met ORR, OS, DoR, PROs Phase III Relapsed/refractory high risk 533 • Arm A: Calquence • Primary endpoint: PFS • FPCD: Q2 2015 ACE-CL-006 (ELEVATE-RR) CLL • Arm B: ibrutinib • Secondary endpoints: comparison of • Data readout: Q1 2021 NCT02477696 incidence of infections, RTs (Richter’s • Primary endpoint met Transformation) and atrial fibrillation, OS Phase III Previously untreated MCL 546 • Arm A: Calquence + bendamustine + rituximab • Primary endpoint: PFS by Lugano •

FPCD: Q1 2017 Other ACE-LY-308 • Arm B: bendamustine + rituximab Classification for NHL • Data anticipated: 2022+ NCT02972840 • Secondary endpoints: IA, PFS, ORR, DoR, time to response, OS

Phase III DLBCL 600 Calquence + rituximab, cyclophosphamide, doxorubicin, • Primary endpoints: safety, ORR • FPCD: Q2 2020 ESCALADE vincristine, and prednisone • Data anticipated: 2022+

NCT04529772 19 - Phase II Relapsed/refractory and 48 Calquence monotherapy • Primary endpoint: ORR • FPCD: Q4 2014 15-H-0016 treatment naïve/del17p • Arm A: lymph node biopsy • Data anticipated: 2022+

NCT02337829 CLL/SLL • Arm B: bone marrow biopsy COVID

27 Approved medicines Late-stage development Calquence (BTK inhibitor) Early development Blood cancers Oncology

Trial Population Patients Design Endpoint(s) Status Phase I/II CLL/SLL/Richter's 306 Calquence monotherapy • Primary endpoints: safety, PK, PD • FPCD: Q1 2014 ACE-CL-001 transformation Dose escalation and expansion • Data anticipated: H2 2021

NCT02029443 CVRM

Phase Ib MCL 70 Calquence in combination with bendamustine and rituxumab • Primary endpoint: safety • FPCD: Q1 2016 ACE-LY-106 • Arm A: treatment naive • Data anticipated: 2022+ NCT02717624 • Arm B: relapsed/refractory • Arm C: treatment naïve: Calquence + venetoclax + rituxumab Phase I Relapsed/refractory follicular 80 • Arm A: Calquence • Primary endpoint: safety • FPCD: Q1 2015 ACE-LY-003 lymphoma • Arm B: Calquence + rituximab • Data anticipated: 2022+ NCT02180711 • Arm C: Calquence + rituximab + lenolidomide R&I

Phase I CLL/SLL/PLL 69 Calquence + obinutuzumab • Primary endpoints: safety, ORR • FPCD: Q4 2014 ACE-CL-003 • Arm A: relapsed/refractory • Secondary endpoints: PD, PFS, TTNT, • Data anticipated: 2022+ NCT02296918 • Arm B: treatment naïve OS Calquence + venetoclax + rituxumab • Arm C: relapsed/refractory

• Arm D: treatment naïve

Other

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28 Approved medicines Late-stage development Calquence (BTK inhibitor) Early development Blood and other cancers Oncology

Trial Population Patients Design Endpoint(s) Status

Phase III CLL TN and R/R 600 • Arm A: treatment naïve • Primary endpoint: safety • Data anticipated: 2022+ CL-312 (ASSURE) • Arm B: relapsed/refractory NCT04008706 • Arm C: prior BTKi therapy • Arm D: concomitant vitamin K antagonists CVRM

Phase I/II Chinese adults R/R MCL and 105 Part 1: R/R B-cell Malignancies • Primary endpoints: safety, ORR • FPCD: Q2 2020 D8220C0007 R/R CLL Part 2: Cohort A: R/R MCL • Data anticipated: H1 2022 NCT03932331 Part 2: Cohort B: R/R CLL Phase I Japanese adults with 34 Dose confirmation and expansion • Primary endpoints: safety, PK • FPCD: Q2 2017 NCT03198650 advanced B-cell • Calquence • Data anticipated: 2022+ malignancies Dose confirmation • Calquence + obinutuzumab R&I

Phase I Healthy volunteers 28 • Part 1: Rel bioavailabilty for capsule vs. tablet • Primary endpoint: safety • FPCD: Q2 2019 D8220C00018 • Part 2: Rel bioavailabilty for oral solution of tablet • Data readout: Q1 2021 NCT04488016

Phase I Healthy volunteers 66 • Arm A: Calquence tablet • Primary endpoint: bioequivalence • FPCD: Q1 2021 D8223C00013 • Arm B: Calquence capsule • Data anticipated: H2 2021

NCT04768985

Other

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29 30 Paediatric neurofibromatosistumours1, solidtype Koselugo compared to fasted state state fasted to compared Koselugo Phase I NCT04590235 Efficacy study PK Phase IChina / / Safety Partnered NCT04495127 study PK Phase IJapan / Safety Lead (Merck Partnered trial) NCT03745989 inhibitor) Koselugo Phase NCT01362803 SPRINT Phase II Trial Partnered Ib witha low + MK - 8353 (ERK - fat meal fat relatedPN. of diagnosisNF1clinical years at trialentrywith a Adolescentsaged≥ 12 to < 18 adultNF1 Pediatric (2 patients Paediatric tumourssolidAdvanced Paediatric NF1 Population ( selumetinib inoperable - 17 old), years NF1 - PN completing T2) completing participantsevaluable (to achieve16 20 to enrolledbe 32 9 80 (dose escalation 25 (Stratum 2) 50 (stratum 1) Patients - 12 trial) , MEK inhibitor) • Single Long follow (60mthsupterm post LSD) Expansionphase(24mths post LSD) Dose confirmation phase(n=6 3 for cycles), arm withtrialSingle 3 phases; • Open • Open Single Design same dose given in a infasted samegiven dose state. Koselugo Koselugo MK • • - - - label trial label trial label arm: arm, multiple dose, sequential, two two sequential,dose, or periodtrialthree multiple arm, - enrolment Stratumpresentat 2: no PN morbidity related Stratumpresentat 1: enrolmentPN relatedmorbidity 8353 withcombination in Koselugo 25mg/m Japanesein paediatricNF1 25mg/m 2 BID given withgiven a low 2 BID BID with 2 strata: Koselugo - PN patients - fat theversusmeal • • • • • • • Endpoints GI toxicity) systemicexposure),safety (especially PK Primary endpoints:(steady state DoR Secondary efficacy endpoints:(ORR, and PK Primary endpoints: effect Secondary PK, endpoints:anti Primary endpoint: andue to drugdiscontinuationsAE Primary endpoints: outcomes/QoL andresponse functional MRI, volumetricby andrateresponse complete measured Primary endpoint: ; TTR; PFS) s Complete Duration of s afety DLTs, AEs, Trial afety, tolerability partial - tumour • • • • • • • • • Status Earlydevelopment Late Approved medicines FPCD: Q3 2021 FPCD: Q4 2020 LPCD: Q4 2020 FPCD: Q3 2020 FPCD: Q1 2019 met Primary endpoint Data readout: Q1 2019 LPCD: Q4 2016 FPCD: Q3 2015 - stage development

COVID-19 Other R&I CVRM Oncology Approved medicines Late-stage development Orpathys (savolitinib, MET inhibitor) Early development NSCLC and other cancers Oncology

Trial Population Patients Design Endpoints Status Phase II Lung PSC and other NSCLC 65 Single arm trial • Primary endpoint: ORR • FPCD: Q1 2017 NCT02897479 • Orpathys QD • Secondary endpoints: PFS, safety • Data readout: Q2 2020

Partnered China parameters CVRM

Phase II EGFRm/MET amplified 56 • Tagrisso and Orpathys contribution of components • Primary endpoint: ORR • FPCD: Q4 2020 NCT04606771 advanced NSCLC • Secondary endpoints: PFS, DoR, OS • Data anticipated: H2 2022

Phase I Advanced NSCLC 85 Dose escalation trial • Primary endpoints: safety and • FPCD: Q2 2013

NCT01985555 (all comers) China tolerability • Data readout: Q3 2019 R&I

Partnered • Secondary endpoints: PK profile

Other

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31 Approved medicines Late-stage development Capivasertib (AKT inhibitor) Early development Breast cancer, prostate cancer Oncology

Trial Population Patients Design Endpoints Status Phase III Locally advanced or 800 Double-blind randomised comparative trial • Primary endpoint: OS • FPCD: Q3 2019 CAPItello-290 metastatic TNBC • Arm 1: capivasertib + paclitaxel • Data anticipated: 2022+

NCT03997123 • Arm 2: placebo + paclitaxel CVRM

Phase III 2L and beyond in AI resistant 834 Double-blind randomised comparative trial • Primary endpoint: PFS • FPCD Q2 2020 CAPItello-291 locally advanced (Inoperable) • Arm 1: capivasertib + Faslodex • Data anticipated: 2022+ NCT04305496 or metastatic HR+/HER2− • Arm 2: placebo + Faslodex breast cancer

Phase III De novo PTEN deficient 1,000 Double-blind randomised comparative trial • Primary endpoint: rPFS • FPCD: Q3 2020 CAPItello-281 metastatic hormone sensitive • Arm 1: capivasertib + abiraterone • Data anticipated: 2022+ NCT04493853 prostate cancer • Arm 2: placebo + abiraterone R&I

Phase III 1L triplet in early 700 Double-blind randomised comparative trial • Primary endpoint: PFS • FPCD Q2 2021 CAPItello-292 relapse/endocrine-resistant • Arm 1: capivasertib + palbociclib + Faslodex • Data anticipated 2022+ NCT04862663 locally advanced (inoperable) • Arm 2: placebo + palbociclib + Faslodex or metastatic HR+/HER2-

breast cancer

Other

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32 Approved medicines Late-stage development Monalizumab (NKG2a mAb) Early development Cancers Oncology

Trial Population Patients Design Endpoints Status Phase III Recurrent or metastatic 600 • Arm A: monalizumab + cetuximab i.v. • Primary: OS • FPCD: Q4 2020 INTERLINK-1 SCCHN, 2L • Arm B: placebo + cetuximab i.v. • Secondary: PFS, ORR, DoR • Data anticipated: 2022+

NCT04590963 CVRM

Global trial

Phase I/II Advanced solid tumours 381 Escalation phase • Primary endpoints: safety • FPCD: Q2 2016 NCT02671435 • monalizumab + Imfinzi i.v. • Exploration phase primary endpoint: • Data anticipated: 2022+ Expansion phase Objective Response per RECIST • monalizumab + Imfinzi i.v. recommended dose • Secondary endpoints include: tumour Exploration phase response (OR, DC, DoR, PFS and OS), • monalizumab + Imfinzi i.v. recommended dose + SoC immunogenicity, pharmacokinetics, R&I systemic therapy with or without biologic agent and pharmacodynamics monalizumab in combination with a biologic agent in adult subjects with CRC

Global trial

Other

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33 Approved medicines Late-stage development Camizestrant (AZD9833, next generation oral SERD) Early development Breast cancer Oncology

Trial Population Patients Design Endpoints Status Phase III HR+ HER2- breast cancer 1342 Randomised, double-blind, comparative trial • Primary endpoint: PFS • FPCD: Q1 2021 SERENA-4 • Arm A: camizestrant + palbociclib • Secondary endpoint: OS, PFS2 • Data anticipated: 2022+

NCT04711252 • Arm B: anastrazole + palbociclib CVRM Phase III HR+ HER2- breast cancer 300 Randomised, double-blind, comparator trial • Primary endpoint: PFS • Initiating SERENA-6 • Arm A: camizestrant (AZD9833) plus Palbociclib or Abemaciclib • Secondary endpoint: OS, PFS2 • Data anticipated: 2022+ NCT04964934 • Arm B: anastrazole or letrozole plus Palbociclib or Abemaciclib

Phase II HR+ breast cancer 236 Randomised, open-label, parallel-group, multicentre trial • Primary outcome: mPFS • FPCD: Q2 2020 NCT04214288 • camizestrant vs. i.m. Faslodex in women with advanced breast cancer. Phase II HR+ breast cancer 84 Randomised, open-label, parallel-group, multicentre trial • Primary outcome: change in ER • FPCD: Q4 2020

NCT04588298 expression between pre- and on- R&I treatment tumour biopsies Phase I HR+ breast cancer 18 Open-label • Primary outcomes: safety and • FPCD: Q4 2020 NCT04541433 • anti-tumour activity of camizestrant in Japanese women with endocrine tolerability resistant HR+ HER2- breast cancer that is not amenable to treatment • Secondary outcome: PK with curative intent. Phase I HR+ breast cancer 304 Escalation phase - open label multicentre trial • Primary outcomes: safety and • FPCD: Q4 2018 NCT03616587 • camizestrant tolerability • camizestrant +Palbociclib, everolimus or abemeciclib. • Secondary outcomes: PK, antitumour

Expansion phase - randomised expansion cohort(s) at potential therapeutic activity Other dose(s) • camizestrant • camizestrant +Palbociclib, everolimus or abemeciclib. Phase I Healthy volunteers 32 Randomsied, open-label • Primary outcome: relative • FPCD: Q3 2020

NCT04546347 bioavailability of different tablet • LPCD: Q4 2020 19

formulations and the effect of food • Data anticipated: H1 2021 - Phase I HR+ HER2- breast cancer 42 Dose escalation • Primary outcomes: safety and • FPCD: Q1 2021 NCT04818632 Chinese patients • camizestrant tolerability, PK • Data anticipated: 2022+ Dose expansion • Secondary outcome: antitumour • camizestrant activity COVID • camizestrant + palbociclib • camizestrant + everolimus

34 Approved medicines Late-stage development Datopotamab deruxtecan (TROP2 ADC) Early development NSCLC Oncology

Trial Population Patients Design Endpoints Status Phase III Previously treated advanced 590 Randomised, open label, parallel assignment • Primary endpoints: PFS, OS • FPCD: Q1 2021 TROPION-Lung01 or metastatic NSCLC without • datopotamab deruxtecan • Secondary endpoints: ORR, DoR, TTR, • Data anticipated: 2022+ NCT04656652 actionable genomic • docetaxel DCR, PK, ADA Partnered alterations Global trial CVRM

Phase II Advanced or metastatic 150 Single-arm, open label • Primary endpoint: ORR • FPCD: Q1 2021 TROPION-Lung05 NSCLC with actionable • datopotamab deruxtecan • Secondary endpoint: DOR, PFS, OS, • Data anticipated: 2022+ NCT04484142 genomic alterations and Global trial safety, PK, ADA Partnered progressed on or after kinase inhibitor therapy and platinum-based chemotherapy R&I Phase I Advanced or metastatic 120 Open label, two-part (dose escalation, dose expansion), • Primary endpoint: DLT, safety • FPCD: Q4 2020 TROPION-Lung02 NSCLC sequential assignment • Secondary endpoint: ORR, DOR, PFS, • Data anticipated: 2022+ NCT04526691 • datopotamab deruxtecan + pembrolizumab +/- platinum OS, PK, ADA Partnered chemotherapy US, Japan

Phase I Advanced or metastatic 120 Open label, two-part (dose escalation, dose expansion), • Primary endpoint: DLT, safety • FPCD: Q1 2021 TROPION-Lung04 NSCLC sequential assignment • Secondary endpoint: ORR, DOR, PFS, • Data anticipated: 2022+ NCT04612751 • datopotamab deruxtecan + Imfinzi +/- platinum OS, PK, ADA Other Partnered chemotherapy

US, Japan

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35 Approved medicines Late-stage development Datopotamab deruxtecan (TROP2 ADC) Early development NSCLC and other cancers Oncology

Trial Population Patients Design Endpoints Status Phase I Subjects with advanced solid 770 Open label, two-part (dose escalation, dose expansion), • Primary endpoint: DLT, safety • FPCD: Q1 2018 TROPION-PanTumor01 tumours sequential assignment • Secondary endpoints: PK, anti-tumour • Data anticipated: H1 2022 NCT03401385 NSCLC • datopotamab deruxtecan activity, ADA Partnered TNBC Japan, US CVRM

HR+ BC

R&I

Other

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36 Oncology – early-stage development Approved medicines Late-stage development MEDI0457 (DNA HPV Vaccine) Early development + Imfinzi (PD-L1 mAb) Oncology Head and neck squamous cell carcinoma (HNSCC)

Trial Population Patients Design Endpoints Status CVRM Phase Ib/IIa HPV associated 50 Multicentre, open label • Primary endpoints: safety and • FPCD: Q3 2017 NCT03162224 recurrent/metastatic head • MEDI0457 and Imfinzi tolerability, ORR • Data anticipated: H2 2021 and neck cancer • Secondary endpoints: PK, ADA, DCR,

OS, PFS

R&I

Other

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38 Approved medicines Late-stage development AZD0466 (Bcl2/xL inhibitor) Early development Cancer Oncology

Trial Population Patients Design Endpoints Status Phase I Advanced haematologic 9 Monotherapy dose escalation, consisting of two arms: • Primary endpoint: safety • FPCD: Q4 2019 NCT04214093 malignancies • Arm A: patients with low risk for tumour lysis syndrome • Secondary endpoints: PK, anti-tumour • Data anticipated: H2 2021 (solid tumours, lymphomas, myelomas) activity • Arm B: patients with high risk for tumour lysis syndrome CVRM (relapsed/refractory haem malignancies)

Phase I/II Advanced haematologic 64 Module 1 • Primary endpoint: safety • FPCD: Q2 2021 NCT04865419 malignancies Part A: Dose escalation • Secondary endpoints: PK, anti-tumour • Data anticipated: 2022+ • AZD0466 activity R&I Part B: Dose expansion • AZD0466 Module 2 - DDI study

• AZD0466 with voriconazole

Other

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39 Approved medicines Late-stage development MEDI1191 (IL12 modRNA) Early development Cancer Oncology

Trial Population Patients Design Endpoints Status Phase I Advanced solid tumours 87 Open-label, dose-escalation and expansion trial of MEDI1191 • Primary endpoints: safety and • FPCD: Q2 2019 NCT03946800 administered intratumourally as monotherapy and in tolerability • Data anticipated: H2 2022 combination with Imfinzi • Secondary endpoints: PK,

immunogenicity and efficacy CVRM

R&I

Other

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40 Approved medicines Late-stage development AZD1390 (ATM inhibitor) Early development Cancer Oncology

Trial Population Subjects Design Endpoints Status

Phase I Recurrent glioblastoma 186 Open label trial • Primary endpoints: safety, • FPCD: Q2 2018 NCT03423628 eligible for re-irradiation, • Arm A: recurrent GBM, AZD1390 +RT in dose escalation tolerability, MTD • Data anticipated: 2022+ brain metastases and cohorts • Secondary endpoint: EFS leptomeningeal disease, • Arm B: brain metastases, AZD1390 +RT in dose escalation CVRM newly-diagnosed cohorts glioblastoma patients • Arm C: primary GBM, AZD1390 +RT in dose escalation

cohorts

R&I

Other

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41 Approved medicines Late-stage development Adavosertib (WEE-1 inhibitor) Early development

Ovarian cancer, uterine serous cancer, solid tumours Oncology

Trial Population Patients Design Endpoints Status Phase II Platinum-resistant (PR) 95 • Arm B: paclitaxel + adavosertib • Primary endpoint: ORR • FPCD: Q1 2015 D6010C00004 ovarian cancer • Arm C: carboplatin + adavosertib • Secondary endpoints: DoR, PFS, OS, • LPCD: Q2 2018

NCT02272790 Global trial DCR, safety and tolerability • Data readout: Q3 2019 CVRM

Phase II Uterine serous carcinoma 120 • adavosertib monotherapy • Primary endpoint: ORR • FPCD: Q4 2020 D601HC00002 • Phase IIb, open-label, single-arm, multicentre study • Secondary endpoints: DoR, depth of NCT04590248 Global trial response, PFS

Phase I Advanced solid tumours 56 Dose escalation trial • Primary endpoints: safety and • FPCD: Q4 2015

D6015C00002 • adavosertib + Imfinzi tolerability, MTD • LPCD: Q4 2018 R&I

NCT02617277 US • Data readout: Q4 2019

Other

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42 Approved medicines Late-stage development AZD2811 (nanoparticle, Aurora B kinase inhibitor) Early development Cancer Oncology

Trial Population Patients Design Endpoints Status

Phase II Extensive-stage small cell 100 Experimental: • Primary endpoints: APF12 per RECIST • FPCD: Q1 2021 NCT04745689 lung cancer • AZD2811 + Imfinzi Induction: 1.1, efficacy • Data anticipated 2022+ • Imfinzi + platinum chemotherapy (carboplatin or cisplatin & CVRM etoposide) Maintenance: • AZD2811 + Imfinzi

Phase I Solid tumours 72 • Arm 1: AZD2811 (NP) dose escalation • Primary endpoints: safety and • FPCD: Q4 2015

NCT02579226 • Arm 2: AZD2811 (NP) dose expansion SCLC tolerability, PK and efficacy • Data readout: Q2 2021

R&I

Other

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43 Approved medicines Late-stage development AZD4573 (CDK9 inhibitor) Early development Blood cancers Oncology

Trial Population Patients Design Endpoints Status Phase I/II R/R haematologic 78 Open label, non-randomised trial • Primary endpoint Part A: safety • FPCD: Q1 2021 NCT04630756 malignancies Module 1 Part A: Dose setting • Primary endpoint Part B: ORR • Data anticipated: 2022+ • AZD4573 + Calquence (100mg twice daily) combination in • Secondary endpoint Part A: safety,

DLBCL, all comers; ramp-up across 3 dose levels anti-tumour activity, PK CVRM Module 1 Part B: Dose expansion • AZD4573 + Calquence (100mg twice daily) combination in GCB and non-GCB DLBCL i.v. route of administration 10 countries across North America, EU, ROW Phase I R/R haematologic 45 • Arm 1: dose escalation in haematological malignancies • Primary endpoints: safety, PK • FPCD: Q4 2017 NCT03263637 malignancies excluding AML/ALL/high-risk MDS/CMML/CLL • Secondary endpoint: efficacy • Data anticipated: H2 2021

• Arm 2: dose escalation in relapsed or refractory AML, ALL, R&I high-risk MDS, CMML, CLL and Richter's syndrome i.v. route of administration

The Netherlands, UK, Germany

Other

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44 Approved medicines Late-stage development Imaradenant (AZD4635, A2AR inhibitor) Early development Cancer Oncology

Trial Population Patients Design Endpoints Status Phase II Prostate cancer 60 • Arm 1: imaradenant + Imfinzi • Primary outcome: efficacy (ORR and • FPCD: Q3 2019 NCT04089553 • Arm 2: imaradenant + oleclumab PSA response) • Data anticipated: 2022+ US • Secondary outcomes: efficacy, PK, safety and tolerability CVRM Phase II Prostate cancer 80 • Arm A: imaradenant + Imfinzi • Primary outcomes: efficacy (rPFS) • FPCD: Q3 2020 NCT04495179 • Arm B: imaradenant+ Imfinzi + cabazitaxel • Secondary outcomes: efficacy (OS, • Data anticipated: 2022+ US, Europe, UK and Korea PSA response, ORR, DoR)

Phase I Phase Ia: patients with 313 Phase Ia – solid tumours or mCPRC: • Primary outcomes: safety and • FPCD: Q2 2016

NCT02740985 advanced solid tumours • imaradenant monotherapy tolerability • Data anticipated: H2 2021 R&I • imaradenant + Imfinzi • Secondary outcomes: preliminary Phase Ib: • imaradenant + abiraterone assessment of anti-tumour activity Post-IO NSCLC • imaradenant + enzalutamide Other post-IO solid tumours • imaradenant + Imfinzi + oleclumab • Immune checkpoint-naïve imaradenant + docetaxel Phase Ib: dose expansions in NSCLC, mCRPC, CRC and other mCRPC, CRC and other solid post-immunotherapy and immune checkpoint-naïve solid tumours tumours • imaradenant monotherapy • imaradenant + Imfinzi

US Other

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45 Approved medicines Late-stage development AZD5305 (selective PARP1 inhibitor) Early development Solid tumours Oncology

Trial Population Patients Design Endpoints Status Phase I/IIa Advanced, metastatic HER2- 612 A modular, open-label, multicentre trial dose escalation • Primary endpoints: safety and • FPCD: Q4 2020 NCT04644068 breast cancer (BRCAm, PALB2m • Module 1: AZD5305 tolerability, PK • Data anticipated: 2022+

or RAD51C/Dm) • Module 2: AZD5305 + paclitaxel • Secondary endpoints: efficacy CVRM Advanced, metastatic TNBC • Module 3: AZD5305 + carboplatin +/- paclitaxel PSR ovarian cancer (BRCAm, PALB2m or RAD51C/Dm) PSR ovarian cancer (HRD+) Prostate (mCRPC, BRCAm)

Prostate (mCRPC, HRRm)

R&I

Other

19

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46 Approved medicines Late-stage development MEDI5395 (rNDV GMCSF) Early development Cancer Oncology

Trial Population Patients Design Endpoints Status Phase I Select advanced solid 188 Open-label dose escalation and dose expansion trial • Primary endpoints: safety and • FPCD: Q4 2019 NCT03889275 tumours • MEDI5395 + Imfinzi tolerability • Data anticipated: 2022+ • Secondary endpoints: PK, PD,

immunogenicity and efficacy CVRM

R&I

Other

19

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47 Approved medicines Late-stage development MEDI5752 (PD-1/CTLA-4 bispecific mAb) Early development Cancer Oncology

Trial Population Patients Design Endpoints Status Phase I/IIa Advanced solid tumours 261 Open-label, dose-escalation and dose-expansion trial • Dose escalation primary endpoints: • FPCD: Q2 2018 NCT03530397 Dose escalation: MEDI5752 i.v. safety, MTD • Data anticipated: 2022+ Dose expansion: MEDI5752 i.v. as monotherapy and in • Dose expansion primary endpoint: combination with chemotherapy antitumour activity based on OR CVRM • Arm A: MEDI5752 i.v. • Secondary endpoints: PK, ADA, • Arm B: MEDI5752 i.v., pemetrexed and carboplatin tumoural baseline PD-L1, antitumour • Arm C: pembrolizumab, pemetrexed and carboplatin activity (OR, DoR, DCR, PFS, OS)

Phase Ib Advanced renal cell 77 Open-label, dose-escalation and dose-expansion trial • Dose escalation primary endpoints: • FPCD: Q3 2020 NCT04522323 carcinoma • MEDI5752 and axitinib safety & tolerability • Data anticipated: 2022+

• Secondary endpoints: PK, ADA and R&I antitumour activity (PFS, OR, DoR,

DCR, TTR, OS)

Other

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48 Approved medicines Late-stage development AZD5991 (MCL1 inhibitor) Early development Blood cancers Oncology

Trial Population Patients Design Endpoints Status Phase I/Ib/IIa Relapsed/refractory 144 • Arm 1: AZD5991 dose escalation and expansion in R/R • Primary endpoint: safety • FPCD: Q3 2017 NCT03218683 haematologic malignancies haematological malignancies • Secondary endpoints: PK, efficacy • Data anticipated: 2022+ • Arm 2: AZD5991 + venetoclax combination dose escalation in R/R AML/MDS CVRM i.v. route of administration

US only

R&I

Other

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49 Approved medicines Late-stage development Ceralasertib (AZD6738, ATR inhibitor) Early development Cancer Oncology

Trial Population Patients Design Endpoints Status

Phase II Solid tumours 52 • Cohort A: ceralasertib; ATM-altered AST • Cohort A primary endpoint: ORR • FPCD: Q1 2021 PLANETTE mCRPC • Cohort B: ceralasertib; ATM-altered mCRPC • Cohort B primary endpoint: • Data anticipated: 2022+

NCT04564027 Composite RR CVRM

Phase I Solid tumours 250 • Arm 1: ceralasertib + carboplatin • Primary endpoints: safety and • FPCD: Q4 2014 NCT02264678 • Arm 2: ceralasertib dose escalation, ceralasertib + Lynparza tolerability, • Data anticipated: 2022+ • Arm 3: ceralasertib + Imfinzi • PK and efficacy North America, Europe and South Korea

Phase I HNSCC 44 Window of opportunity • Primary endpoint: Biomarker • FPCD: Q4 2017 NCT03022409 • Arm 1: ceralasertib change • Data anticipated: H2 2021 R&I • Arm 2: Lynparza

US, France, Taiwan and the UK

Other

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50 Approved medicines Late-stage development AZD7648 (selective DNA-PK inhibitor) Early development Advanced solid tumours Oncology

Trial Population Patients Design Endpoints Status Phase I Advanced malignancies 234 Modular dose escalation and dose expansion trial • Primary outcomes: safety and • FPCD: Q4 2019 NCT03907969 • Arm 1: AZD7648 monotherapy tolerability • Data anticipated: 2022+ • Arm 2: AZD7648 + pegylated liposomal doxorubicin • Secondary outcomes: PK, • Arm 3: AZD7648 + Lynparza Cytochromes P450, preliminary anti- CVRM

US, UK tumour activity

R&I

Other

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51 Approved medicines Late-stage development AZD8701 (FOXP3 antisense oligonucleotide) Early development Solid tumours Oncology

Trial Population Patients Design Endpoints Status Phase I/Ib Advanced solid tumours 123 Dose escalation and dose expansion trial • Primary endpoints: safety & tolerability • FPCD: Q3 2020 NCT04504669 • Arm 1: AZD8701 monotherapy • Secondary endpoints: PK, PD, preliminary • Data anticipated: 2022+

• Arm 2: AZD8701 & Imfinzi combination therapy anti-tumour activity CVRM i.v. route of administration

US, CA, FR, ES

R&I

Other

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52 Approved medicines Late-stage development MEDI9253 (rNDV-IL12) Early development Solid tumours Oncology

Trial Population Patients Design Endpoints Status Phase I Advanced solid tumours 86 Open-label, dose-escalation and expansion trial • Primary endpoint: safety and • FPCD: Q4 2020 NCT04613492 • MEDI9253 + Imfinzi tolerability • Data anticipated: 2022+ • Secondary endpoints: PK, PD,

immunogenicity and efficacy CVRM

R&I

Other

19

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53 Approved medicines Late-stage development Oleclumab (CD73 mAb) Early development Cancer Oncology

Trial Population Patients Design Endpoints Status

Phase Ib/II Pancreatic 339 • Arm A1: gemcitabine and nab paclitaxel i.v. • Primary endpoints: safety and anti- • FPCD: Q2 2018 NCT03611556 1L and 2L with prior • Arm A2: gemcitabine and nab paclitaxel i.v. + oleclumab i.v. tumour activity • Data anticipated: H2 2021

gemcitabine-based • Arm A3: gemcitabine and nab paclitaxel i.v. + oleclumab i.v. • Secondary endpoints include: PFS, PK, CVRM chemotherapy + Imfinzi i.v. immunogenicity, safety and anti- • Arm B1: mFOLFOX (oxaliplatin, leucovorin, 5-FU) i.v. tumour activity • Arm B2: mFOLFOX (oxaliplatin, leucovorin, 5-FU) i.v. + oleclumab i.v. • Arm B3: mFOLFOX (oxaliplatin, leucovorin, 5-FU) i.v. + oleclumab i.v. + Imfinzi i.v.

US, Norway, Spain and Australian trial centres

R&I

Other

19

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54 Approved medicines Late-stage development IPH5201 (CD39 mAb) Early development Solid tumours Oncology

Trial Population Patients Design Endpoints Status Phase I Advanced solid tumours 204 Open-label, dose-escalation trial to determine MTD of IPH5201 • Primary endpoints: AE, SAE, DLT • FPCD: Q1 2020 NCT04261075 as monotherapy, or in combination with Imfinzi +/- oleclumab. • Secondary endpoints: OR, DC, PK, ADA • Data anticipated: 2022+ Partnered • Part 1: IPH5201 monotherapy dose escalation to MTD • Part 2: IPH5201 + Imfinzi dose escalation to MTD CVRM • Part 3: IPH5201 + Imfinzi + oleclumab dose escalation to MTD Route of administration: i.v.

4 countries - US and 3 in EU.

R&I

Other

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55 BioPharmaceuticals – approved medicines and late-stage pipeline Approved medicines Late-stage development Farxiga (SGLT2 inhibitor) Early development Heart failure and chronic kidney disease Oncology

Trial Population Patients Design Endpoints Status Phase IIIIII Patients Withwith CKD 43044,304 • ArmArm 1: 1:Farxiga Farxiga10mg10mg or or5 mg5 mg QD QD • PrimaryPrimaryendpoint:endpoint:timetime to theto thefirst first • FPCD:FPCD: Q1 Q1 2017 2017 DAPADapa--CKDCKD • ArmArm 2: 2:placebo placebo occurrenceoccurrence of ofany any of ofthe the components components of • LPCD:LPCD: Q1 Q1 2020 2020 NCT03036150 theof composite: the composite: ≥50% ≥50% sustained sustained decline • Data readout: Q2 2020 Global trial --2121 countriescountries • PrimaryData readout: endpoint Q2 met 2020

NCT03036150 in eGFR or reaching ESRD or CV death CVRM ordecline renal death in eGFR or reaching ESRD or • Primary endpoint met CV death or renal death

Phase IIIIII CHF patients patients with HFpEF 61006,100 • ArmArm 1: 1:Farxiga Farxiga10mg10mg QD QD • PrimaryPrimaryendpoint:endpoint: time time to theto thefirst first • FPCD:FPCD: Q4 Q4 2018 2018 DELIVER • ArmArm 2: 2:placebo placebo occurrenceoccurrence of ofany any of ofthe the components components of • LPCD:LPCD: Q4 Q4 2020 2020 NCT03619213 theof composite: the composite: CV death CV death or or • Data anticipated: H2 2021 NCT03619213 •GlobalGlobal trial trial - 21- 21 countries countries hospitalisation for HF or an urgent HF Data anticipated: H1 2022 visithospitalisation for HF or an urgent HF visit

Phase IIIIII Patients with myocardial myocardial 64006,400 • ArmArm 1: 1:Farxiga Farxiga10mg10mg QD QD • PrimaryPrimary endpoint:endpoint: time time to theto thefirst first • FPCD:FPCD: Q4 Q4 2020 2020 R&I DAPA--MI infarction • ArmArm 2: 2:placebo placebo occurrenceoccurrence of ofany any of ofthe the components components of • DataData anticipated: anticipated: 2022+ 2022+ NCT04564742 theof composite: the composite: hospitalization hospitalisation for HFfor or NCT04564742 •GlobalGlobal trial trial - 2- 2countries countries CV death HF or CV death

Phase I Healthy Chinese volunteers 80 • Arm 1: Farxiga 5 mg + metformin 500 mg XR • Primary endpoint: Plasma AUCinf, • FPCD: Q2 2021 NCT04856007 • Arm 2: Farxiga/metformin XR FDC 5/500 mg AUClast and Cmax of Farxiga and • LPCD: Q2 2021 • Arm 3: Farxiga 10 mg + metformin 1000 mg XR metformin respectively. • Data anticipated: H2 2021 • Arm 4: Farxiga/metformin XR FDC 10/1000 mg

China only Other

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57 Approved medicines Late-stage development Brilinta (P2Y12 receptor antagonist) Early development Cardiovascular risk reduction Oncology

Trial Population Patients Design Endpoints (primary) Status Phase III Patients with acute ischaemic 11000 • Arm 1: Brilinta 90mg BID • Primary endpoint: prevention of the • FPCD: Q1 2018 THALES stroke or transient ischaemic • Arm 2: placebo BID composite of subsequent stroke and • LPCD: Q4 2019 NCT03354429 attack On a background of acetylsalicylic acid if not contra-indicated or death at 30 days • Data readout: Q1 2020 not tolerated • Secondary endpoints include: • Primary endpoint met CVRM Global trial – 28 countries prevention of subsequent ischaemic stroke at 30 days; reduction of overall

disability at 30 days

R&I

Other

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58 Approved medicines Late-stage development Lokelma (sodium zirconium cyclosilicate) Early development Hyperkalaemia Oncology

Trial Population Patients Design Endpoints Status Phase IIIb Patients with ESRD with 134 • Arm 1: Lokelma 5g QD for 8 weeks on non-dialysis days. • Primary endpoint: proportion of • FPCD: Q4 2020 DIALIZE China hyperkalemia and on stable Option to uptitrate to 10 and15g QD. patients who maintain a pre-dialysis • Data readout: H1 2022 NCT04217590 haemodialysis • Arm 2: placebo QD for 8 weeks on non-dialysis days serum K between 4.0-5.0 mmol/L on 3 China out of 4 dialysis treatments following CVRM the long interdialytic interval Phase III Hyperkalaemia 250 Open-label Lokelma 10g TID for 48 hours followed by: • Primary endpoint: maintenance of • FPCD: Q2 2021 HARMONIZE Asia • Arm 1: Lokelma 5g QD for 28 days normokalaemia • Data readout: H2 2022 NCT03528681 • Arm 2: Lokelma 10g QD for 28 days • Arm 3: placebo QD for 28 days China, India

Phase III Patients with with recurrent 2300 • Arm 1: Lokelma 5g-15g QD for 4 weeks on non-dialysis days, • Primary endpoint: Time to first • FPCD: Q3 2021 R&I DIALIZE-Outcomes hyperkalaemia on chronic thereafter adjusted monthly occurrence of SCD, stroke, or • Data readout: 2022+ NCT04847232 haemodialysis • Arm 2: placebo QD hospitalisation/intervention/ED visit

Global trial – 22 countries due to arrhythmias

Other

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59 Approved medicines Late-stage development Roxadustat (HIF-PH inhibitor) Early development Anaemia Oncology

Trial Population Patients Design Endpoints Status

Phase III Anaemia in CKD in patients 922 • Arm 1: roxadustat • Primary endpoint: haemoglobin • FPCD: Q4 2012 ANDES not receiving dialysis • Arm 2: placebo response • LPCD: Q3 2018 NCT01750190 Global trial • Data readout: Q4 2018 Partnered • Primary endpoint met CVRM Sponsored by FibroGen

Phase III Anaemia in CKD in patients 597 • Arm 1: roxadustat • Primary endpoint: haemoglobin • FPCD: Q2 2013 ALPS not receiving dialysis • Arm 2: placebo response • LPCD: Q4 2017 NCT01887600 Global trial • Data readout: Q3 2018 Partnered • Primary endpoint met

Sponsored by Astellas R&I Phase III Anaemia in CKD in patients 616 • Arm 1: roxadustat • Primary endpoint: haemoglobin • FPCD: Q1 2014 DOLOMITES not receiving dialysis • Arm 2: darbepoetin alfa response • LPCD: Q4 2019 NCT02021318 Global trial • Data readout: Q1 2020 Partnered • Primary endpoint met Sponsored by Astellas

Phase III Anaemia in CKD in patients 2781 • Arm 1: roxadustat • Primary efficacy endpoint: • FPCD: Q3 2014 OLYMPUS not receiving dialysis • Arm 2: placebo haemoglobin response • LPCD: Q4 2018 NCT02174627 Global trial • Primary safety objective: contribute • Data readout: Q4 2018 CV safety data to pooled safety • Primary endpoint met analyses across the Phase III program Sponsored by AstraZeneca Other

Phase III Anaemia in CKD in patients 2133 • Arm 1: roxadustat • Primary efficacy endpoint: • FPCD: Q3 2014 ROCKIES receiving dialysis • Arm 2: epoetin alfa haemoglobin response • LPCD: Q3 2018 NCT02174731 Global trial • Data readout: Q4 2018

• Primary safety objective: contribute • Primary endpoint met 19

CV safety data to pooled safety Sponsored by AstraZeneca - analyses across the Phase III

programme COVID

60 Approved medicines Late-stage development Roxadustat (HIF-PH inhibitor) Early development Anaemia Oncology

Trial Population Patients Design Endpoints Status

Phase III Anaemia in CKD in patients 741 • Arm 1: roxadustat • Primary endpoint: haemoglobin • FPCD: Q4 2014 SIERRAS receiving dialysis • Arm 2: epoetin alfa response • LPCD: Q3 2018 NCT02273726 Global trial • Data readout: Q4 2018 Partnered • Primary endpoint met CVRM Sponsored by FibroGen

Phase III Anaemia in CKD in patients 838 • Arm 1: roxadustat • Primary endpoint: haemoglobin • FPCD: Q4 2014 PYRENEES receiving dialysis • Arm 2: epoetin alfa or darbepoetin alfa response • LPCD: Q3 2018 NCT02278341 Global trial • Data readout: Q3 2018 Partnered • Primary endpoint met Sponsored by Astellas

Phase III Anaemia in newly initiated 1,043 • Arm 1: roxadustat • Primary endpoint: haemoglobin • FPCD: Q4 2013 R&I HIMALAYAS dialysis patients • Arm 2: epoetin alfa response • LPCD: Q3 2018 NCT02052310 Global trial • Data readout: Q4 2018 Partnered • Primary endpoint met Sponsored by FibroGen

Phase III Anaemia in lower risk MDS 184 Open label roxadustat lead-in • Primary endpoint: proportion of • FPCD: Q3 2017 NCT03263091 patients • Arm 1: roxadustat patients achieving transfusion • Data anticipated: H1 2022 Partnered • Arm 2: placebo independence Sponsored by FibroGen

US/global trial Other

Phase II/III Anaemia in lower risk MDS 175 Open label roxadustat lead-in • Primary endpoint: haemoglobin NCT03303066 patients • Arm 1: roxadustat response • FPCD: Q2 2018 Partnered • Arm 2: placebo • Data anticipated: 2022+

China Sponsored by FibroGen 19 Phase II Anaemia in patients 100 Open label trial • Primary endpoint: maximum change • FPCD: Q3 2019 - NCT04076943 receiving chemotherapy • roxadustat 3x week in haemoglobin within 16 weeks from • LPCD: Q3 2020 Partnered treatment for non-myeloid 16 weeks baseline without RBC transfusion • Data anticipated: H2 2021

malignancies US Sponsored by FibroGen COVID

61 Approved medicines Late-stage development Eklira/Tudorza (LAMA, DPI) Early development COPD Oncology

Trial Population Number of patients Design Endpoints Status Phase I Healthy Chinese 20 Open-label trial in healthy Chinese male and female participants. • Primary endpoints: safety and • Initiating NCT03276052 volunteers • aclidinium bromide 400 μg DPI - single and multiple twice daily tolerability, PK • Data anticipated: 2022+ doses

China CVRM

R&I

Other

19

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62 Approved medicines Late-stage development Duaklir Genuair (LAMA/LABA, DPI) Early development COPD Oncology

Trial Population Patients Design Endpoints Status

Phase III Patients with stable COPD 1060 • Arm 1: Duaklir Genuair 400/12 μg DPI • Primary endpoints: • FPCD: Q1 2017 AVANT • Arm 2: aclidinium bromide 400 μg DPI • Change from baseline in one hour • Data anticipated: 2022+

NCT03022097 • Arm 3: formoterol fumarate 12 μg DPI morning post-dose dose FEV1 Duaklir CVRM • Arm 4: tiotropium 18 μg DPI Genuair 400/12 μg compared to Global trial – five countries Aclidinium bromide at Week 24 • Change from baseline in morning pre- dose (trough) FEV1 of Duaklir Genuair 400/12 μg compared to Formoterol fumarate at Week 24 • Change from baseline in trough FEV1 of Aclidinium bromide 400 µg

compared to placebo at Week 24 R&I

Other

19

- COVID

63 Approved medicines Late-stage development Breztri, Trixeo (PT010, LAMA/LABA/ICS, pMDI) Early development Asthma Oncology

Trial Population Patients Design Endpoints Status Phase III Severe asthma 2800 Randomised, double-blind, double dummy, parallel group and • Primary endpoint: Change from • FPCD: Q1 2021 KALOS multicentre baseline in forced expiratory volume • Data anticipated: 2022+ NCT04609878 Treatments (24 to 52 week variable length) in 1 second (FEV1) area under the • BGF MDI 320/28.8/9.6µg BID pMDI curve 0 to 3 hours (AUC0-3) at Week CVRM • BGF MDI 320/14.4/9.6µg BID pMDI 24 • BFF MDI 320/9.6µg BID pMDI • Primary endpoint of pooled trials • Symbicort 320/9µg BID pMDI D5982C00007 and D5982C00008: Rate Multi-country of severe asthma exacerbations • Secondary endpoint: Change from baseline in morning pre-dose trough FEV1 at Week 24

Phase III Severe asthma 2800 Randomised, double-blind, double dummy, parallel group and • Primary endpoint: Change from • FPCD: Q1 2021 R&I LOGOS multicentre baseline in forced expiratory volume • Data anticipated: 2022+ NCT04609904 Treatments (24 to 52 week variable length) in 1 second (FEV1) area under the • BGF MDI 320/28.8/9.6µg BID pMDI curve 0 to 3 hours (AUC0-3) at Week • BGF MDI 320/14.4/9.6µg BID pMDI 24 • BFF MDI 320/9.6µg BID pMDI • Primary endpoint of pooled trials • Symbicort 320/9µg BID pMDI D5982C00007 and D5982C00008: Rate Multi-country of severe asthma exacerbations • Secondary endpoint: Change from baseline in morning pre-dose trough

FEV1 at Week 24 Other

19

- COVID

64 Approved medicines Late-stage development Daliresp/Daxas (PDE4 inhibitor, oral) Early development COPD Oncology

Trial Population Patients Design Endpoints Status Post Launch COPD 124,080 A retrospective cohort trial comparing COPD patients aged 40 • Primary endpoint: all-cause mortality • Data anticipated: 2022+ PASS years and older with new exposure to roflumilast with up to 5 (up to five years) NCT03381573 unexposed (i.e., not roflumilast-exposed) COPD controls matched by propensity score (PS), age, sex, and year of cohort CVRM entry. The trial is using electronic healthcare databases in the US (Military Health System database), Germany (German Pharmacoepidemiological Research Database), and Sweden (national databases including healthcare, death, and

demographics data) and Norway.

R&I

Other

19

- COVID

65 Approved medicines Late-stage development Fasenra (IL5R mAb) Early development Severe, uncontrolled asthma Oncology

Trial Population Patients Design Endpoints Status Phase III A multicentre, open-label, 447 • Arm 1: Fasenra 30mg Q4W s.c. • Primary endpoint: safety and • FPCD: Q2 2016 MELTEMI safety extension trial with • Arm 2: Fasenra 30mg Q8W s.c. tolerability • LPCD: Q3 2019 NCT02808819 Fasenra for asthmatic adults Global trial - 15 countries • Data readout: Q3 2020 on ICS plus LABA2 Agonist • Primary endpoint met CVRM Age 18-75 years Phase IIIb Severe eosinophilic 598 • Arm 1: Fasenra 30mg Q8W s.c. • Primary endpoint: reduction of oral • FPCD: Q3 2018 PONENTE asthmatics receiving HD ICS + 38-week trial corticosteroid dose • LPCD: Q3 2019 NCT03557307 LABA and chronic OCS with or Global trial – 16 countries • Data readout: Q4 2020 without additional asthma • Primary endpoint met controller(s).

Age 18 Years and older R&I Phase III Severe, uncontrolled asthma, 666 • Arm 1: Fasenra 30mg Q8W s.c. • Primary endpoint: annual asthma • FPCD: Q4 2017 D3250C00036 China despite background • Arm 2: placebo s.c. exacerbation rate • Data readout: 2022+ ICS/LABA Trial (MIRACLE) controller medication, MD & 56-week trial • Secondary endpoints: assess NCT03186209 HD ICS + LABA ± chronic OCS Global trial – 4 countries pulmonary function, asthma Age 12-75 years symptoms, other asthma control

metrics

Other

19

- COVID

66 Approved medicines Late-stage development Fasenra (IL5R mAb) Early development Severe, uncontrolled asthma Oncology

Trial Population Patients Design Endpoints Status Phase III Severe asthma, inadequately 2133 Randomised double-blind safety extension trial • Primary endpoint: safety and • FPCD: Q4 2014 BORA controlled despite • Arm 1: Fasenra 30mg Q4W s.c. tolerability • Data readout: Q3 2018 NCT02258542 background controller • Arm 2: Fasenra 30mg Q8W s.c. • Primary endpoint met medication, MD & HD 56-week (adults) CVRM ICS/LABA ± chronic OCS 108-week (adolescents) Age 12-75 years Global trial – 24 countries

Phase III Severe asthma, inadequately 162 • Arm 1: Fasenra 30mg Q4W s.c. • Primary endpoint: functionality, • FPCD: Q2 2015 GREGALE controlled despite 28-week (adults) reliability, and performance of a pre- • Data readout: Q2 2016 NCT02417961 background controller Global trial – two countries filled syringe with Fasenra • Primary endpoint met R&I medication, MD & HD ICS + administered at home LABA ± chronic OCS Age 18-75 years

Phase lll Allergen-induced 46 A double-blind, randomised, parallel group, placebo-controlled • Primary endpoint: safety and • FPCD Q4 2016 ARIA inflammation in mild, atopic multicentre trial to evaluate the effect of Fasenra on allergen- tolerability • LPCD: Q2 2019 NCT02821416 asthma induced inflammation in mild, atopic asthma patients • Primary endpoint: the effect of • Data readout: Q4 2020 Age 18-65 years • Arm 1 : Fasenra 30mg Q4W s.c. Fasenra on allergen induced • Primary endpoint met • Arm 2: placebo Q4W s.c. eosinophil changes in sputum and 37-week trial allergen-induced late asthmatic Other response

Phase lll Adolescent and young adult 103 A multicentre, randomised, double-blind, parallel group, • Primary endpoints: • FPCD: Q3 2016 ALIZE patients with severe asthma placebo-controlled trial • Post-dose strain-specific HAI) antibody • Data readout: Q3 2017

NCT02814643 receiving a seasonal influenza • Arm 1: Fasenra 30mg Q4W s.c. with one dose of seasonal GMFRs • Primary endpoint met 19 vaccine influenza virus vaccine i.m. • Post-dose strain-specific serum HAI - Ages 12-21 years • Arm 2: placebo Q4W s.c. with one dose of seasonal antibody GMTs influenza virus vaccine i.m. • Proportion of patients who experience 12-week trial a strain-specific post-dose antibody response with antibody response COVID defined as a ≥4-fold rise in HAI antibody titre

67 Approved medicines Late-stage development Fasenra (IL5R mAb) Early development Severe, uncontrolled asthma, COPD and other eosinophilic diseases Oncology

Trial Population Patients Design Endpoints Status Phase III Severe asthma on ICS/LABA 121 Open label • Primary endpoint: percentage of • FPCD: Q4 2016 GRECO Age 18-75 years • Fasenra 30mg Q4W patients/caregivers who successfully • Data readout: Q4 2017 NCT02918071 28-week trial self administer at home • Primary endpoint met Global trial - two countries CVRM

Phase lllb Patients with severe asthma 659 • Arm 1: Fasenra 30mg Q8W s.c. • Primary endpoint: rate of asthma • FPCD: Q3 2017 ANDHI uncontrolled on SoC • Arm 2: placebo Q8W s.c. exacerbations • LPCD: Q1 2019 NCT03170271 treatment. 24-week trial • Secondary outcome measures: Saint • Data readout: Q4 2019 Age 18-75 Global trial – 15 countries George Respiratory Questionnaire • Primary endpoint met

(SGRQ) R&I

Phase III Patients with moderate to 868 Double-blind, placebo controlled • Primary endpoint: annualized rate of • FPCD Q4 2019 RESOLUTE very severe COPD with a • Arm 1: Fasenra 100mg Q8W s.c. moderate or severe exacerbations • Data anticipated: 2022+ NCT04053634 history of frequent • Arm 2: placebo Q8W s.c. over 56 weeks exacerbations on a 56-week treatment background triple therapy Global trial – 26 countries (ICS/LABA/LAMA) Age 40-85 years Phase III Patients With non-cystic 420 Double blind treatment period and open label extension study • Primary endpoint: annualised • Initiating MAHALE fibrosis bronchiectasis (NCFB) • Arm 1: Fasenra 30mg Q4W s.c. bronchiectasis exacerbation rate at • Data anticipated: 2022+ Other with eosinophilic • Arm 2: placebo Q4W s.c. week 52 inflammation 52-week Global trial – 17 countries Age 18 years and older

Phase I Healthy volunteers 180 Open label trial • Primary endpoint: PK comparability • FPCD: Q1 2017 19 AMES age 18-55 years • Fasenra 30 mg PK administered by APFS device • Data readout: Q3 2017 - NCT02968914 • Fasenra 30 mg PK administered by AI device 8-week trial

Global trial – two countries COVID

68 Approved medicines Late-stage development Fasenra (IL5R mAb) Early development Nasal polyposis and other eosinophilic diseases Oncology

Trial Population Patients Design Endpoints Status Phase III Patients with severe bilateral 413 • Arm 1: Fasenra 30mg Q8W s.c. • Primary endpoint: effect of Fasenra • FPCD: Q1 2018 OSTRO nasal polyps who are still • Arm 2: placebo s.c. on nasal polyp burden and on patient • LPCD: Q2 2019 NCT03401229 symptomatic despite 56-week trial reported nasal blockage • Data readout: Q3 2020 standard of care therapy Global trial- 8 countries • Co-primary endpoints met CVRM

Age 18-75 years

Phase III Patients with eosinophilic 148 • Arm 1: Fasenra 30mg Q8W s.c. • Primary endpoint: Change in • FPCD: Q4 2019 ORCHID chronic rhinosinusitis with • Arm 2: placebo Q8W s.c. endoscopic total nasal polyp score • Data anticipated: 2022+ NCT04157335 severe nasal polyposis 56-week trial and change in mean nasal blockage Global trial - 10 countries score Age 18-75 years R&I

Phase III Patients with relapsing or 140 • Arm 1: Fasenra 30mg Q4W s.c. • Primary endpoint: Proportion of • FPCD: Q4 2019 MANDARA refractory EGPA on • Arm 2: mepolizumab 300mg Q4W s.c. patients achieving remission (BVAS=0 • Data anticipated: 2022+ NCT04157348 corticosteroid therapy with 52-week trial with a minimum 1-year open label extension and OCS dose ≤ 4mg/day) at both or without stable Global trial- 9 countries weeks 36 and 48. immunosuppressive therapy

Age 18 years and older Other Phase III Patients with HES (history of 120 • Arm 1: Fasenra 30mg Q4W s.c. • Primary endpoint: Time to first HES • FPCD :Q3 2020 NATRON persistent eosinophilia >1500 • Arm 2: placebo Q4W s.c. worsening/flare • Data anticipated: H2 2022 NCT04191304 cells/μL with evidence of 24-week trial with a minimum 1-year open label extension end organ manifestations Global trial- 9-12 countries attributable to eosinophilia)

and signs or symptoms of HES 19

worsening/flare at visit 1 -

Age 12 years and older COVID

69 Approved medicines Late-stage development Fasenra (IL5R mAb) Early development Gastrointestinal diseases Oncology

Trial Population Patients Design Endpoints Status Phase III Documented diagnosis of EoE 170 Double blind treatment period and open label period(s) • Primary endpoints: Histologic • FPCD: Q4 2020 MESSINA Age 12 to 65 years • Arm 1: Fasenra 30mg Q4W s.c. response at week 24, change from • Data anticipated: H2 2022 NCT04543409 • Arm 2: placebo Q4W s.c. baseline in DSQ score at week 24 24-week Global trial – 12 countries CVRM

Phase III Patients with eosinophilic 220 Double blind treatment period and open label extension • Dual primary endpoints at week 24: • Initiating HUDSON gastritis and/or • Arm 1: Fasenra s.c. • Proportion of patients achieving a • Data anticipated: 2022+ gastroenteritis. Age >=12yrs • Arm 2: placebo s.c. histological response in the stomach 24-week and/or in the duodenum Global trial • Absolute change in symptoms of

EG/EGE R&I

Other

19

- COVID

70 Approved medicines Late-stage development Fasenra (IL5R mAb) Early development Dermatology Oncology

Trial Population Patients Design Endpoints Status Phase III Patients with symptomatic 120 Double blind treatment period and open label period • Primary endpoint: Proportion of • FPCD: Q2 2021 FJORD (newly diagnosed or • Arm 1: Fasenra patients with complete sustained (≥2 • Data anticipated: 2022+ NCT04612790 relapsing) bullous pemphigoid • Arm 2: placebo months) remission off OCS at 36 weeks

36-week CVRM Global trial

Phase II Patients with 160 Double blind treatment period and open label period • Primary endpoint: Change from • FPCD: Q4 2020 ARROYO moderate/severe chronic • Arm 1: Fasenra regimen 1 baseline in ISS7 at week 12 • Data anticipated: H1 2022 NCT04612725 spontaneous urticaria, and • Arm 2: Fasenra regimen 2 resistant to H1 treatment • Arm 3: placebo 24-week Global trial R&I

Phase II Patients with moderate to 160-200 Double blind treatment period and open label periods • Primary endpoint: Proportion of • FPCD: Q4 2020 HILLIER severe atopic dermatitis • Arm 1: Fasenra patients with an IGA 0/1 and a • Data anticipated: 2022+ NCT04605094 despite treatment with topical • Arm 2: placebo decrease in IGA of ≥ 2 points at week medications 16-week 16

Global trial

Other

19

- COVID

71 Approved medicines Late-stage development Tezepelumab (TSLP mAb) Early development Severe, uncontrolled asthma Oncology

Trial Population Patients Design Endpoints Status Phase III Severe asthma 1,061 • Arm 1: tezepelumab s.c. • Primary endpoint: Annual asthma • FPCD: Q1 2018 NAVIGATOR Age 12-80 years • Arm 2: placebo s.c. exacerbation rate • LPCD: Q3 2019 NCT03347279 52 week trial • • Secondary endpoints: Change from Data readout: Q4 2020 CVRM Partnered Global trial – 18 countries baseline in pre-BD FEV1, asthma • Primary endpoint met related QoL (AQLQ(S)+12), asthma control (ACQ-6) Phase III Severe asthma 150 • Arm 1: tezepelumab s.c. • Primary endpoint: Reduction from • FPCD: Q2 2018 SOURCE Age 18-80 years • Arm 2: placebo s.c. baseline in daily OCS dose while not • LPCD: Q4 2019 NCT03406078 48 week trial losing asthma control • Data readout: Q4 2020 Partnered Global trial – seven countries • Secondary endpoint: Annual asthma • Primary endpoint not met

exacerbation rate R&I

Phase III Severe asthma 951 Extension trial to NAVIGATOR and SOURCE • Primary endpoint: Exposure adjusted • FPCD: Q1 2019 DESTINATION Age 12-80 years • Arm 1: tezepelumab s.c. rates of AEs/SAEs • LPCD: Q4 2020 NCT03706079 • Arm 2: placebo s.c. • Secondary endpoints: Annual asthma • Data anticipated: H2 2022 Partnered 52 week trial (subjects from NAVIGATOR); 56 week trial (subjects exacerbation rate from SOURCE)

Global trial – 18 countries Other Phase III Severe asthma 216 • Arm 1: tezepelumab s.c. via AI • Primary endpoint: Proportion of health • FPCD: Q2 2019 PATH-HOME Age 12-80 years • Arm 2: tezepelumab s.c. via APFS care professionals and patients • LPCD: Q3 2019 NCT03968978 24 week trial /caregivers who successfully • Data readout: Q4 2020 • Partnered Global trial – 4 countries administrated tezepelumab in clinic Primary endpoint met

and at home with an APFS or an AI, 19

respectively - COVID

72 Approved medicines Late-stage development Tezepelumab (TSLP mAb) Early development Severe, uncontrolled asthma, COPD & CRSwNP Oncology

Trial Population Patients Design Endpoints Status

Phase III Severe chronic rhinosinusitis 400 • Arm 1: tezepelumab s.c. • Co-primary endpoint: Nasal Polyp • FPCD: Q2 2021

WAYPOINT with nasal polyps (CRSwNP) • Arm 2: placebo s.c. Score and Participant Reported Nasal • Data anticipated: 2022+ CVRM NCT04851964 Age 18+ 52 week trial Congestion Partnered Global trial – 11 countries Phase III Severe asthma 396 • Arm 1: tezepelumab s.c. • Primary endpoint: Annual asthma • FPCD: Q3 2019 DIRECTION Age 18-80 years • Arm 2: placebo s.c. exacerbation rate • Data anticipated: 2022+ NCT03927157 52 week trial • Secondary endpoints: Change from Partnered Regional Asia trial – three countries baseline in pre-BD FEV1, asthma related QoL (AQLQ(S)+12), asthma

control (ACQ-6) R&I

Phase III Severe asthma 65 • Arm 1: tezepelumab s.c. • Primary endpoint: Number of patients • FPCD: Q2 2019 NOZOMI 12-80 years 52 week trial with adverse events • LPCD: Q4 2019 NCT04048343 Local trial - Japan • Data readout: Q2 2021 Partnered

Phase II Severe asthma 116 • Arm 1: tezepelumab s.c. • Primary endpoint: number of airway • FPCD: Q4 2018 CASCADE Age 18-75 years • Arm 2: placebo s.c. submucosal inflammatory cells/mm2 • LPCD: Q4 2019

NCT03688074 28 week trial of bronchoscopic biopsies • Data readout: Q2 2021 Other Partnered Global trial – five countries • Primary endpoint met

Phase IIa Moderate to very severe 338 • Arm 1: tezepelumab s.c. • Primary endpoint: Rate of moderate or • FPCD: Q3 2019 COURSE COPD • Arm 2: placebo s.c. severe COPD exacerbations • Data anticipated: 2022+ NCT04039113 52 week trial

Age 40-80 19

Partnered -

Global trial – 10 countries COVID

73 Approved medicines Late-stage development PT027 (SABA/ICS, pMDI) Early development Asthma Oncology

Trial Population Patients Design Endpoints Status Phase III Moderate to severe asthma 3100 Randomised, double-blind, multicentre, parallel group • Primary endpoint: Time to first severe • FPCD: Q4 2018 MANDALA Treatments (minimum 24-week treatment period) asthma exacerbation • Data anticipated: H2 2021 • NCT03769090 • BDA (budesonide albuterol) MDI 80/180 μg prn Secondary endpoints: Severe CVRM Managed by Avillion • BDA MDI 160/180 μg prn exacerbation rate (annualised); total • AS (albuterol sulphate) MDI 180 μg prn corticosteroid exposure over the Multi-country treatment period; asthma Control Questionnaire -5 change from baseline and responder analysis at Week 24; asthma quality of life questionnaire for 12 years and older/paediatric asthma quality of life questionnaire change

from baseline and responder analysis R&I at week 24

Phase III Mild to moderate asthma 1000 Randomised, double-blind, multicentre and parallel-group • Dual primary endpoints: Change from • FPCD: Q2 2019 DENALI Treatments (12 week treatment period) baseline in FEV1 AUC0-6 hours over 12 • LPCD: Q2 2021 NCT03847896 • BDA MDI 80/180 μg QID weeks; change from baseline in trough • Data anticipated: H2 2021 Managed by Avillion • BDA MDI 160/180 μg QID FEV1 at week 12 • BD MDI 160 μg QID • AS MDI 180 μg QID • placebo MDI QID Other Multi-country

Phase III Asthma with exercise induced 60 Randomised, double-blind, multicentre crossover • Primary endpoint: The maximum • FPCD: Q1 2020 TYREE bronchoconstriction Treatments (single dose) percentage fall from post-dose, pre- • LPCD: Q3 2020 NCT04234464 • exercise baseline in forced expiratory • Data readout: Q4 2020 BDA MDI 160/180 μg 19 Managed by Avillion • placebo MDI QID volume in 1 second (FEV1) observed • Primary endpoint met - US up to 60 minutes post-exercise

challenge COVID

74 Approved medicines Late-stage development Anifrolumab (type I interferon receptor mAb) Early development Lupus (SLE / LN) Oncology

Trial Population Patients Design Endpoints Status Phase III Moderate to severe SLE 450 • Arm 1: 300mg i.v. anifrolumab Q4W for 48 weeks • Primary endpoint: response in SLE • FPCD: Q4 2015 TULIP-1 SLE • Arm 2: 150mg i.v. anifrolumab Q4W for 48 weeks responder index at week 52 • LPCD: Q4 2017 NCT02446912 • Arm 3: placebo i.v. Q4W for 48 weeks • Data readout: Q3 2018 • Primary endpoint not met CVRM Phase III Moderate to severe SLE 360 • Arm 1: 300mg i.v. anifrolumab Q4W for 48 weeks • Primary endpoint: response in SLE • FPCD: Q4 2015 TULIP-2 SLE • Arm 2: placebo i.v. Q4W for 48 weeks responder index at week 52 • LPCD: Q4 2017 NCT02446899 BICLA at week 52 • Data readout: Q3 2019 • Primary endpoint met

Phase III Moderate to severe SLE 630 • Arm 1: 300mg i.v. anifrolumab Q4W for 152 weeks • Primary endpoint: extension to • FPCD: Q2 2016

TULIP LTE • Arm 2: placebo i.v. Q4W for 152 weeks evaluate long-term safety and • LPCD: Q4 2018 R&I NCT02794285 tolerability • Data anticipated: H1 2022 Phase ll Moderate to severe SLE 307 • Arm 1: 300mg i.v. anifrolumab Q4W for 48 weeks • Primary endpoint: response in SLE • FPCD: Q1 2012 NCT01438489 patients • Arm 2: 1000mg i.v. anifrolumab Q4W for 48 weeks responder index at 6 months • LPCD: Q1 2015 • Arm 3: placebo i.v. Q4W for 48 weeks • Data readout: Q3 2014 Phase II Moderate to severe SLE 218 • Arm 1: anifrolumab, i.v. Q4W for 104 weeks • Primary endpoint: open-label • FPCD: Q1 2013 NCT01753193 patients extension to evaluate long-term • Data readout: Q4 2018 safety and tolerability

Phase II​​ Moderate to severe SLE 32​ • Arm 1: 150mg s.c. every other week​ • PK/PD, safety, tolerability, primary • FPCD: Q1 2017​ Other NCT02962960​ patients​ • Arm 2: 300mg s.c. every other week​ analysis at week 12, secondary • LPCD: Q4 2017 • Arm 3: placebo s.c. every other week​​ analysis at week 52​ • Data readout: Q1 2018​

Phase II Active proliferative LN 150 • Arm 1: 900 mg i.v. Q4W for 12 weeks then 300mg i.v. • Response in proteinuria at week 52 • FPCD: Q4 2015

TULIP-LN1 anifrolumab Q4W for 36 weeks • LPCD: Q4 2018 19

NCT02547922 • Arm 2: 300 mg i.v. anifrolumab Q4W for 48 weeks • Primary endpoint not met -

• Arm 3: placebo i.v. Q4W for 48 weeks COVID

75 Approved medicines Late-stage development Anifrolumab (type I interferon receptor mAb) Early development Lupus (SLE / LN) Oncology

Trial Population Patients Design Endpoints Status

Phase III Moderate to severe SLE 360 • Arm 1: 120 mg SC QW, 52 wk in aPFS • Primary endpoint: reduction in overall • Initiating TULIP-SC patients • Arm 2: placebo comparator injection in aPFS disease activity, as measured by BICLA • Data anticipated: 2022+

NCT04877691 at week 52 CVRM Phase III Moderate to severe SLE 328 • Arm 1: 300 mg anifrolumab i.v. Q4W • Primary endpoint: BICLA response at • FPCD: Q3 2021 AZALEA-SLE patients • Arm 2: 300 mg placebo i.v.Q4W week 52 • Data anticipated: 2022+

NCT04931563 Asia

R&I

Other

19

- COVID

76 Approved medicines Late-stage development Brazikumab (IL23 inhibitor) Early development Inflammatory bowel disease (Crohn’s disease, ulcerative colitis) Oncology Trial Population Patients Design Endpoints Status Phase IIb / III Crohn’s disease 928 Stage 1 • Stage 1 primary endpoints: percentage of patients • FPCD: Q4 2018 INTREPID • Arm 1: brazikumab high i.v. dose on day 1, 29 and 57 + s.c. with CDAI remission at week 12 • Data anticipated: 2022+ NCT03759288 brazikumab on day 85 and every 4 weeks through week 48 • Stage 1 secondary endpoints: Percentage of patients • Arm 2: brazikumab low i.v. dose on day 1, 29 and 57 s.c. with endoscopic response at week 12, Percentage of

brazikumab on day 85 and every 4 weeks through week 48 patients with clinical remission at week 12 CVRM • Arm 3: placebo • Stage 2 Primary endpoints: Percentage of patients Stage 2 with endoscopic response at week 52; Percentage of • Arm 1: brazikumab high i.v. dose on day 1, 29 and 57 + s.c. patients with clinical remission at week 52 brazikumab on day 85 and every 4 weeks through week 48 • Stage 2 Secondary endpoints: percentage of patients • Arm 2: brazikumab low i.v. dose on day 1, 29 and 57 s.c. with endoscopic response at both Week 12 and brazikumab on day 85 and every 4 weeks through week 48 Week 52; percentage of patients with clinical • Arm 3: adalimumab s.c. on day 1, 15, 29 and every 2 weeks remission at both Week 12 and Week 52

through week 50 R&I Phase III Crohn’s Disease 161 Open label extension • Primary endpoint: safety of long-term treatment • FPCD: Q2 2019 NCT03961815 with brazikumab • Data anticipated: 2022+

Phase II Ulcerative Colitis 375 • Arm 1: brazikumab dose 1 i.v. on day 1, 15 and 43 + s.c. • Primary endpoint: clinical remission at week 10 • FPCD: Q3 2018 EXPEDITION brazikumab from day 71 and every 4 weeks • Secondary endpoint: sustained clinical remission at • Data anticipated: 2022+ NCT03616821 • Arm 2: brazikumab dose 2 i.v. on day 1, 15 and 43 + s.c. week 10 and 54 brazikumab from day 71 and every 4 weeks • Arm 3: brazikumab dose 3 i.v. on day 1, 15 and 43 + s.c.

brazikumab from day 71 and every 4 weeks Other • Arm 4: vedolizumab 300 mg i.v. on day 1, 15 and 43 + i.v. vedolizumab from day 99 and every 8 weeks • Arm 5: placebo Phase II Ulcerative Colitis 150 Open label extension • Clinically significant adverse events • FPCD: Q1 2020

NCT04277546 • Data anticipated: 2022+

19

- COVID

77 Approved medicines Late-stage development Nirsevimab (Respiratory syncytial virus mAb-YTE ) Early development Infection Oncology

Trial Population Patients Design Endpoints Status Phase III Healthy infants (born 35 3000 (total) Randomised, Double-blind, placebo-controlled • Primary endpoints: efficacy • FPCD: Q3 2019 (efficacy cohort) MELODY weeks 0 days or greater GA) 1500 (efficacy cohort) Arm 1: nirsevimab i.m. • Secondary endpoints: safety, PK, ADA • LPCD: Q3 2020 (efficacy cohort) • NCT03979313 1500 (safety cohort) Arm 2: placebo i.m. Data readout: Q1 2021 (efficacy CVRM Global trial – 31 countries cohort) • Primary endpoint met • FPCD: Q2 2021 (safety cohort) • Data anticipated: H2 2022 (safety cohort) Phase II/III High risk preterm (born 35 925 Randomised, Double-blind, palivizumab-controlled • Primary endpoints: safety and • FPCD: Q3 2019 MEDLEY weeks 0 day or less GA), CHD Arm 1: nirsevimab i.m. tolerability • LPCD: Q4 2020 • • NCT03959488 and CLD infants eligible to Arm 2: Synagis i.m. Secondary endpoints: PK, ADA and Data readout: Q2 2021 R&I receive palivizumab Global trial – 32 countries descriptive efficacy • Safety objective met Phase IIb 29-35 WK GA (Gestational 1453 Randomised, double-blind, placebo-controlled trial • Primary endpoints: safety and efficacy • FPCD: Q4 2016 NCT02878330 age) infants Arm 1: nirsevimab 50mg i.m. • LPCD: Q4 2017 Arm 2: placebo i.m. • Data readout: Q4 2018 • Primary endpoint met Phase II Immunocompromised 100 Open-label, Uncontrolled, single-dose Study • Primary endpoints: safety and • FPCD: Q3 2020 Global IC children who are ≤ 24 months • nirsevimab i.m. tolerability • Data anticipated 2022+ NCT04484935 of age at the time of dose Route of administration: i.m. • Secondary endpoints: PK, ADA,

administration efficacy Other Phase I Healthy Chinese adults, 18-45 24 Randomised, Double-blind, placebo-controlled • Primary endpoint: PK • FPCD: Q2 2021 China years of age Arm 1: nirsevimab 50mg i.m. • Secondary endpoints: ADA, safety • LPCD: Q2 2021 NCT04840849 Arm 2: placebo i.m. • Data anticipated H1 2022 Route of administration: i.m.

China only

19

- COVID

78 Approved medicines Late-stage development AZD1222/AZD2816 (SARS-CoV-2) Early development Prevention of COVID-19 Oncology

Trial Population Patients Design Endpoints Status

Phase II/III Main efficacy trial: healthy 10812 Single-blinded, randomised, controlled, multicentre trial with • Primary endpoint: efficacy and safety • FPCD: Q2 2020 COV002 (UK) adults aged ≥18 years sequential age escalation/de-escalation immunogenicity sub- • Secondary endpoints: safety, • LPCD: Q4 2020 NCT04400838 studies that include prime boost tolerability, reactogenicity, and CVRM • Partnered Healthy adults 56 - <70 years AZD1222 immunogenicity Healthy adults 70 years • Control vaccine: MenACWY Healthy children 5 – 12 years UK

Phase III Healthy adults 32429 Adaptive, double-blinded, randomised placebo-controlled trial • Primary endpoints: efficacy, safety, • FPCD: Q3 2020 D8110C00001 (US, global) Aged 18-65 years • AZD1222 tolerability, and reactogenicity • LPCD: Q1 2021 NCT04516746 • placebo • Secondary endpoints: immunogenicity • Data readout: Q1 2021 US, Peru, Chile

Phase III Health professionals and 10416 Single-blinded, randomised, controlled multicentre trial • Primary endpoint: efficacy • FPCD: Q2 2020 R&I COV003 (Brazil) adults with high potential for • AZD1222 • Secondary endpoints: safety, • LPCD: Q4 2020 NCT04536051 exposure to SARS-CoV-2 • Control vaccine: MenACWY tolerability, reactogenicity, and Partnered Age 18-55 years Brazil immunogenicity

Phase III Healthy adults 100 Open-label, non-comparative trial • Primary endpoints: safety, tolerability • Paused D8111C00001 Age ≥18 years Russia • Secondary endpoints: immunogenicity NCT04540393 Phase I/II Healthy adults 1077 Single-blinded, randomised, controlled, multicentre trial • Primary endpoint: efficacy and safety • FPCD: Q2 2020 COV001 (UK) Age 18-55 years • AZD1222 • Secondary endpoints: safety, • LPCD: Q2 2020 Other NCT04324606 • Control vaccine: MenACWY tolerability, reactogenicity, and Partnered UK immunogenicity Phase I/II Healthy adults 2130 Adaptive, double-blinded, randomised placebo-controlled trial • Primary endpoint: efficacy, safety, and • FPCD: Q2 2020 COV005 (SA) Age 18-65 years • AZD1222 immunogenicity • LPCD: Q4 2020

NCT04444674 • placebo 19

Partnered HIV+ subgroup South Africa - COVID

79 Approved medicines Late-stage development AZD1222/AZD2816 (SARS-CoV-2) Early development Prevention of COVID-19 Oncology

Trial Population Patients Design Endpoints Status

Phase II/III AZD2816 Healthy adults 2590 Partially double-blinded, randomized, active-controlled trial in • Primary endpoint: safety, tolerability • FPCD: Q2 2021 (UK, Brazil, South Africa, Aged > 18 years unvaccinated or previously vaccinated participants • Secondary endpoint: immunogenicity • LPCD: Q3 2021

Poland) • AZD2816 CVRM D7220C00001 • AZD1222

Phase I/II Healthy adults 256 Double-blinded, randomised, placebo-controlled multicentre • Primary endpoints: safety, tolerability, • FPCD: Q3 2020 D8111C00002 Age ≥18 years trial reactogenicity, immunogenicity • LPCD: Q4 2020 NCT04568031 • AZD1222 • Secondary endpoints: immunogenicity • Data readout: Q4 2020 • placebo Japan Phase I/II Healthy adults 400 Double-blinded, randomised, placebo-controlled multicentre • • FPCD: Q4 2020

Primary endpoints: safety, tolerability, R&I COV004 (Kenya) trial reactogenicity, immunogenicity • AZD1222 • Secondary endpoints: immunogenicity • Control vaccine: rabies Kenya

Phase II Healthy children and 261 Single-blinded, randomized muilt-centre trial • Primary endpoints: safety, tolerability, • FPCD: Q1 2021 COV006 (UK) adolescents age 6-17 years • AZD1222 reactogenicity ISRCTN15638344 • Meningococcal Group B vaccine • Secondary endpoints: immunogenicity Partnered UK

Phase I Healthy adults 54 Open label, randomized, dose-escalation trial of AZD1222 • Primary endpoint: safety, tolerability • FPCD: Q1 2021 Other COV008 (UK) Age 18-55 administered intranasally • Secondary endpoint: immunogenicity • LPCD: Q4 2020 • AZD1222 NCT04816019 UK

Partnered

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80 Approved medicines Late-stage development AZD7442 (LAAB combination of AZD8895 & AZD1061) Early development Prevention and treatment of COVID-19 Oncology

Trial Population Patients/Subjects Design Endpoints Status

Phase III Adults having 5,000 Double-blinded, randomised, placebo controlled, multi centre • Primary endpoint: positive • FPCD: Q4 2020 PROVENT increased risk for inadequate study to determine safety and efficacy in pre-exposure symptomatic illness post –dose • LPCD: Q1 2021 D8850C00002 response to prophylaxis • Secondary endpoints: Incidence of • Data anticipated: H2 2021 CVRM • NCT04625725 active immunisation or Arm 1: AZD7442 nucleocapsid antibodies, incidence of having increased risk for • Arm 2: placebo SARS-CoV-2 infection AZD7442/placebo (2:1) emergency visits, incidence of PCR USA, UK, Belgium, France, Spain positive, incidence of ADA to AZD7442 in serum and AZD7442 serum concentrations Phase III Adults with potential 1,125 Double-blinded, randomised, placebo controlled, multi centre • Primary endpoint: positive • FPCD: Q4 2020

STORM CHASER exposure to an identified study to determine safety and efficacy in post-exposure symptomatic illness post –dose • LPCD: Q1 2021 R&I D8850C00003 individual with confirmed prophylaxis • Secondary endpoints: Incidence of • Data readout: Q2 2021 • • NCT04625972 SARS-COV2 infection and at Arm 1: AZD7442 nucleocapsid antibodies, incidence of Primary endpoint not met risk of developing COVID-19 • Arm 2: placebo AZD7442/placebo (2:1) COVID-19 related death, incidence of USA and UK all cause mortality, incidence of ADA to AZD7442 in serum and ZD7442 serum concentrations PHASE III Adults with confirmed mild to 1,700 Double-blinded, randomised, placebo controlled, multi centre • Primary endpoint: efficacy in the • FPCD: Q1 2021 TACKLE moderate SARS-COV2 study to determine safety and efficacy for treatment of Covid-19 prevention of the composite endpoint • Data anticipated: H2 2021 NCT04723394 infection. Symptomatic in non-hospitalised patients of either severe COVID-19 or death Other patients with documented • Arm 1: AZD7442 from any cause through study day 29 positive SARS-Cov-2 • Arm 2: placebo molecular test AZD7442/placebo (1:1) UK, Germany, Spain, Italy, Hungary, Russia, US, Mexico, Japan, Poland, Czech Republic, Peru, Argentina, Brazil, Bulgaria and

Ukraine 19 - Phase I Healthy adults 60 Double-blinded, randomised, placebo controlled, single • Primary endpoint: safety, tolerability • FPFD: Q3 2020 NCT04507256 Aged 18-55 years ascending dose study and PK • LPCD: Q3 2020 • Arm 1: AZD7442 • Secondary endpoint: immunogenicity

• Arm 2: placebo COVID AZD7442/placebo (10:2) UK

81 Approved medicines Late-stage development Other COVID-19 trials Early development Treatment of COVID-19 Oncology

Trial Population Patients/Subjects Design Endpoints Status Phase III COVID-19 1250 • Current SoC or current SoC + Farxiga • Primary outcome measures: time to • FPCD: Q2 2020 DARE-19 first occurrence of either death from • LPCD: Q1 2021 NCT04350593 any cause or new/worsened organ • Data readout: Q1 2021 dysfunction through 30 days of follow • Primary endpoint not met CVRM up or improving clinical recovery.

Phase IIIa COVID-19 300 • Current SoC or SoC + Pulmicort • Primary outcome measures: • FPCD: Q2 2020 TACTIC-COVID proportion of patients in both arms • Data anticipated: Q2 2021 NCT04355637 fulfilling the criteria for treatment failure Phase IIIa COVID-19 478 • Current SoC or SoC + Pulmicort • Primary outcome measures: • FPCD: Q2 2020

STOIC emergency department attendance of • Data readout: Q1 2021 R&I NCT04416399 hospitalisation related to COVID-19

Phase IIIa COVID-19 436 • Current SoC or SoC + Symbicort • Primary outcome measures: time (in • FPCD: Q2 2020 INHASCO days) to clinical improvement within • Data anticipated: Q2 2021 NCT04331054 30 days after randomisation

Phase II COVID-19 1407 • Current SoC or current SoC + Farxiga + ambrisentan • Primary outcome measures: time to • FPCD: Q4 2020 TACTIC-E incidence of the composite endpoint • Data anticipated: H1 2022 NCT04393246 of: death, mechanical ventilation, extracorporeal membrane Other oxygenation, cardiovascular organ support, or renal failure Phase II COVID-19 180 • Current SoC or current SoC + MEDI3506 • Primary endpoints: time to a 2-point • FPCD: Q2 2020 ACCORD improvement on a 9-point category • Data anticipated: H2 2021

ordinal scale, discharge from hospital, 19 or considered fit for discharge -

whichever comes first by Day 29 COVID

82 BioPharmaceuticals – early-stage development Approved medicines Late-stage development Cotadutide (GLP-1-glucagon agonist) Early development Diabetes/CKD, NASH Oncology

Trial Population Patients Design Endpoints Status Phase II Adults with type-2 44 • Part A: cotadutide or placebo s.c. • Primary endpoint: change in hepatic glycogen concentration • FPCD: Q2 2018 NCT03555994 diabetes • Part B: cotadutide s.c. or placebo s.c. or postprandially, adjusted by liver volume • Part A LPCD: Q4 2018 liraglutide s.c. • Secondary endpoints: safety, tolerability, immunogenicity • Data readout: Q1 2019 Sweden, Netherlands, UK • Part B FPCD: Q1 2020 CVRM • LPCD: Q1 2021 • Data readout: Q2 2021 Phase IIb Overweight and 27 • Cotadutide or placebo s.c. • Primary endpoints: efficacy body weight loss • FPCD: Q4 2018 NCT03596177 obese patients with UK • Secondary endpoint: change in total energy intake; change in total • LPCD: Q4 2019 type-2 diabetes energy expenditure, active energy expenditure, resting energy • Data readout: Q4 2020 expenditure; safety

Phase IIb Obese patients with 74 • Arm 1: cotadutide high dose s.c. • Primary endpoints: safety and tolerability • FPCD: Q4 2019 R&I NCT04019561 non-alcoholic fatty • Arm 2: placebo high dose s.c. • Secondary endpoints: change in hepatic fat fraction; change in • Data anticipated: H2 2021 liver disease • Arm 3: cotadutide low dose s.c. liver fat volume; change in visceral adipose tissue (NAFLD)/non- • Arm 4: placebo low dose s.c. alcoholic US steatohepatitis (NASH) Phase II Chronic kidney 225 • Arm 1: cotadutide 100 micrograms • Primary endpoint: efficacy change in UACR • FPCD: Q4 2020 NCT04515849 disease with type 2 • Arm 2: cotadutide 300 micrograms • Secondary endpoints: Change in HbA1c; change in glucose • LPCD: H2 2021

diabetes mellitus • Arm 3: cotadutide 600 micrograms measured by CGM; effects on body weight; safety, tolerability, • Data anticipated: H2 2022 Other • Arm 4: semaglutide Immunogenicity • Arm 5: placebo Phase I Healthy adult 36 • Primary endpoint: exposure following a single s.c. of cotadutide at • FPCD: Q4 2019 NCT04091373 patients each of 3 different sites of injection • LPCD: Q1 2020

• Secondary endpoints: immunogenicity; safety and tolerability • Data readout: Q4 2020

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84 Approved medicines Late-stage development Verinurad (URAT1 inhibitor) Early development CKD, HFpEF Oncology

Trial Population Patients Design Endpoints Status Phase II Patients with: 861 • Arm A: verinurad 12 mg + allopurinol 300 mg • Primary endpoints: ratio of urinary • FPCD: Q3 2019 SAPPHIRE • sUA ≥6.0 mg/dL • Arm B: verinurad 7.5 mg + allopurinol 300 mg albumin to urinary creatinine • Data anticipated: H1 2022 NCT03990363 • eGFR ≥25 mL/min/1.73 • Arm C: verinurad 3 mg to 24 mg + allopurinol 300 mg • Secondary endpoints: changes in m2 Chronic Kidney • Arm D: verinurad placebo + allopurinol 300 mg eGFR, Cystatin C, and uric acid CVRM Disease Epidemiology • Arm E: verinurad placebo + allopurinol placebo Collaboration (CKD-EPI USA, China, Czech Republic, France, Hungary, Israel, Italy, formula) Mexico, Poland, Romania, Slovakia, South Africa, Spain • Mean UACR between 30 mg/g and 5000 mg/g Phase II Patients with heart failure 435 • Arm A: verinurad 24 mg + allopurinol 300 mg • Primary endpoint: peak V02 Change • FPCD: Q3 2020 AMETHYST with preserved ejection • Arm B: verinurad 12 mg + allopurinol 300 mg from baseline at Week 28 in exercise • Data readout: 2022+ R&I NCT04327024 fraction • Arm C: verinurad placebo + allopurinol 300 mg capacity • Arm D: verinurad placebo + allopurinol placebo • Secondary endpoint: change from Argentina, Australia, Austria, Bulgaria, Canada, Germany, baseline at Week 28 in Kansas-City Mexico, Poland, Russia, Slovakia South Korea, USA Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS)

Phase I Healthy volunteers 24 Single-centre, randomised, placebo-controlled, double-blind, 3- • Primary endpoint: ratio of urinary • FPCD: Q3 2020 NCT03118739 period, cross-over trial albumin to urinary creatinine • Data readout: H2 2020

• Arm A: verinurad 24 mg ER8 formulation + 300 mg • Secondary endpoints: sUA, eGFR, Other allopurinol serum creatinine, serum cystatin C • Arm B: verinurad 40 mg IR formulation + 300 mg allopurinol • Arm C: matched placebos for both verinurad and allopurinol

Germany

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85 Approved medicines Late-stage development Verinurad (URAT1 inhibitor) Early development CKD, HFpEF Oncology

Trial Population Patients Design Endpoints Status

Phase I Healthy volunteers 14 Single-centre, randomised, open-label, 3-period, fixed • Primary endpoint: PK • FPCD: Q3 2020 NCT04532918 sequence, trial • LPCD: Q4 2020

• Arm A: verinurad 7.5 mg ER8 formulation + 300 mg • Data readout: H1 2021 CVRM allopurinol under fasted conditions • Arm B: verinurad 7.5 mg IR formulation + 300 mg allopurinol + cyclosporin 600 mg under fasted conditions • Arm C: verinurad 7.5 mg IR formulation + 300 mg allopurinol + rifampicin 600 mg under fasted conditions Germany

Phase I Healthy volunteers 25 • Arm A: verinurad prolonged release HPMC capsule and • Primary endpoint: bioavailability • FPCD: Q2 2021 NCT04550234 allopurinol tablet, fasted state • Data anticipated: H2 2021 R&I • Treatment B: verinurad/allopurinol FDC capsule, fasted state • Arm C: verinurad/allopurinol FDC capsule, fed state • Treatment D: verinurad prolonged release HPMC capsule and allopurinol tablet, fed state • Arm E: verinurad prolonged release gelatin capsule, fasted state The trial is a single centre, randomised, open-label, single-dose,

5-period, 5-treatment, crossover study conducted in Germany. Other

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86 Approved medicines Late-stage development AZD2373 Early development Chronic kidney disease Oncology

Trial Population Patients Design Endpoints Status Phase I Healthy volunteers 48 SAD. Dose escalation in 6 cohorts with 6 volunteers receiving • Primary endpoints: safety and • FPCD: Q1 2020 NCT04269031 AZD2373 and 2 volunteers receiving placebo in each cohort tolerability • Arm 1: AZD2373 • Secondary endpoint: PK parameters • Arm 2: placebo CVRM

US

R&I

Other

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87 Approved medicines Late-stage development AZD2693 (antisense oligonucleotide) Early development NASH Oncology

Trial Population Patients Design Endpoints Status Phase I Healthy volunteers 62 SAD. 6 cohorts with 6 volunteers receiving AZD2693 and 2 • Primary endpoints: safety and • FPCD: Q4 2019 NCT04142424 volunteers receiving placebo in each cohort tolerability • Data anticipated: H2 2021 • Arm 1: AZD2693 s.c. • Secondary endpoint: PK • Arm 2: placebo s.c. CVRM US

Phase I NASH/NAFLD F0-F3 60 MAD. 3 cohorts receiving AZD2693 and placebo in each cohort • Primary endpoints: safety and • FPCD: Q2 2021 NCT04142424 • Arm 1: AZD2693 s.c. tolerability • Data anticipated: H1 2022 • Arm 2: placebo s.c. • Secondary endpoint: PK

US

R&I

Other

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88 Approved medicines Late-stage development AZD3427 (relaxin) Early development Heart failure Oncology

Trial Population Patients Design Endpoints Status

Phase I SAD – Healthy volunteers 104 Multicentre single and multiple ascending dose study • Primary endpoints: safety and • FPCD: Q4 2020 NCT04630067 MAD – Heart failure Part A SAD 6 cohorts tolerability • Data anticipated: H1 2022 • Arm 1: AZD3427 CVRM • Arm 2: placebo Part B MAD • Arm 1: AZD3427 • Arm 2: placebo US

Phase I Heart failure 16 Mechanistic study to evaluate the vasodilatory effects • Primary endpoint: change from • FPCD: H2 2021

NCT04890548 of AZD3427 baseline in absolute forearm blood • Data anticipated: H1 2022 R&I • Cohort 1: HFpEF AZD3427 a sequence of 5 IA infusions into flow the brachial artery • Secondary endpoints: Change from • Cohort 2: HFrEF a sequence of 5 IA infusions into the baseline in forearm blood flow ratio in brachial artery the infused arm and between arms;

UK ADA; safety & tolerability

Other

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89 Approved medicines Late-stage development AZD3366 Early development Cardiovascular disease Oncology

Trial Population Patients Design Endpoints Status Phase I Healthy volunteers 103 SAD trial • Primary endpoints: safety and • FPCD: Q4 2020 NCT04588727 Part A tolerability 7 cohorts with 6 volunteers receiving AZD3366 and 2 volunteers • Secondary endpoint: PK parameters receiving placebo in each cohort; three cohorts with Japanese CVRM subjects 5 receiving AZD3366 1 receiving placebo; 1 Chinese cohort of 6 receiving AZD3366 2 receiving placebo • Arm 1: AZD3366 • Arm 2: placebo

Part B 12 subjects • Arm 1: AZD3366 + Brilinta + ASA R&I

• Arm 2: placebo + Brilinta + ASA

Other

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90 Approved medicines Late-stage development MEDI3506 (IL33 ligand mAb) Early development Diabetic kidney disease Oncology

Trial Population Patients Design Endpoints Status

Phase II Adult patients with diabetic 565 • Arm A: MEDI3506 dose 1 + Farxiga • Primary endpoints: safety and efficacy • FPCD: Q4 2019 NCT04170543 kidney disease • Arm B: MEDI3506 dose 2 + Farxiga • Data anticipated: 2022+

• Arm C: MEDI3506 dose 3 + Farxiga CVRM • Arm D: MEDI3506 dose 4 + Farxiga • Arm E: placebo + Farxiga

USA, Canada, Japan and additional countries.

R&I

Other

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91 Approved medicines Late-stage development AZD4831 (MPO inhibitor) Early development Cardiovascular disease Oncology

Trial Population Patients Design Endpoints Status Phase IIa HFpEF 96 • Arm 1: AZD4831 • Primary endpoint: The change from • FPCD: Q4 2018 NCT03756285 • Arm 2: placebo baseline in MPO activity in % • Data readout: Q2 2021

Global trial – five countries CVRM

Phase I Healthy patients c. 96 SAD trial • Primary endpoints: safety and • FPCD: Q3 2016 NCT02712372 • Arm 1: AZD4831 tolerability • LPCD: Q4 2016 • Arm 2: placebo • Secondary endpoint: PK parameters • Data readout: Q2 2017 Germany

Phase I Healthy patients c. 40 MAD trial • Primary endpoints: safety and • FPCD: Q2 2017

NCT03136991 • Arm 1: AZD4831 tolerability • LPCD: Q4 2017 R&I • Arm 2: placebo • Secondary endpoint: PK parameters • Data readout: Q1 2018 USA

Phase I Healthy patients 32 MAD trial in Japanese and Chinese patients • Primary endpoints: safety and • FPCD Q1 2020 NCT04232345 tolerability • Data anticipated: H2 2021

Phase I Healthy patients 6 Open label hADME trial • Primary endpoints: mass balance, with • FPCD: Q2 2020 NCT04407091 • a single oral dose of [14C] AZD4831 routes and rates of elimination of • LPCD: Q3 2020 Other UK [14C]AZD4831; Metabolite profiling • Data anticipated: H2 2021 and structural identification; PK and

total radioactivity

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92 Approved medicines Late-stage development AZD5718 (FLAP inhibitor) Early development Cardiovascular disease & Chronic Kidney Disease Oncology

Trial Population Patients Design Endpoints Status

Phase IIb Proteinuric CKD 632 Randomised, double-blind, placebo-controlled, multicentre, • Primary endpoints: dose-response • FPCD: Q4 2020 NCT04492722 dose-ranging trial efficacy, safety, PK • Data anticipated: H2 2022

• AZD5718 CVRM • placebo

Phase IIa CAD 129 • Arm 1: AZD5718 Dose A • Primary endpoint: PD effect of • FPCD: Q4 2017 NCT03317002 • Arm 2: AZD5718 Dose B AZD5718 by assessment of u-LTE4 • LPCD: Q4 2019 • Arm 3: placebo • Data readout: Q1 2021

Global trial – three countries in Europe R&I Phase I Healthy patients 6 Open label hADME trial • Primary endpoint: Mass balance, with • FPCD: Q2 2019 NCT03948451 • a single oral dose of 14C-AZD5718 routes and rates of elimination of 14C- • LPCD: Q2 2019 UK AZD5718; Metabolite profiling and structural identification; PK and total radioactivity

Phase I Healthy patients 14 BA trial. Open-label, randomised, 3-period, 3-treatment, • Primary endpoints: safety and • FPCD: Q4 2019 NCT04087187 crossover design tolerability, PK • LPCD: Q4 2019

• AZD5718 Other Phase I Healthy patients 12 BA trial. Open-label, randomised, single-dose, combined 2x2 • Primary endpoints: bioavailability, • FPCD: Q1 2020 NCT04210388 dose and 3x3 dose crossover design in fixed sequence. safety and tolerability • LPCD: Q1 2020 • AZD5718

Phase I Healthy patients 16 BA trial. Open-label, randomised, single-dose, 3-period, single • Primary endpoints: bioavailability, • FPCD: Q1 2021

NCT0473275 dose, crossover design safety and tolerability • LPCD: Q1 2021 19

• AZD5718 • Data anticipated: H2 2021 - COVID

93 Approved medicines Late-stage development AZD8233 (PCSK9 inhibitor, subcutaneous) Early development Dyslipidaemia Oncology

Trial Population Patients Design Endpoints Status Phase II Dyslipidaemia 108 • Arm 1: High AZD8233 dose • Primary endpoint: efficacy • FPCD: Q4 2020 NCT04641299 • Arm 2: Medium AZD8233 dose • LPCD: Q1 2021 • Arm 3: Low AZD8233 dose • Data anticipated: H2 2021 • Arm 4: placebo CVRM 12 weeks 3 countries (US, Slovakia and Denmark) Phase II Dyslipidaemia 91 Part A: 11 subjects randomized in an 8:3 ratio • Part A primary endpoints: safety and • FPCD: Q1 2021 NCT04823611 • Arm 1: High AZD8233 dose tolerability • Data anticipated: H2 2022 • Arm 2: placebo • Part B primary endpoint: efficacy Part B: 80 subjects randomized across four different treatment arms in a 1:1:1:1 ratio • Arm 1: High AZD8233 dose R&I • Arm 2: Medium AZD8233 dose • Arm 3: Low AZD8233 dose • Arm 4: placebo 12 weeks Japan Phase I Healthy subjects 72 SAD trial • Primary endpoints: safety and • FPCD: Q3 2018 NCT03593785 7 cohorts tolerability • LPCD: Q3 2019 • Arm1: AZD8233 • Secondary endpoints: PK and PD • Data anticipated: H2 2021

• Arm 2: placebo parameters Other US Phase I Dyslipidaemia 33 MAD trial • Primary endpoints: safety and • FPCD: Q1 2020 NCT04155645 3 cohorts tolerability • LPCD: Q4 2020 • Arm1: AZD8233 • Secondary endpoints: PK and PD • Data anticipated: H2 2021

• Arm 2: placebo parameters 19

US - COVID

94 Approved medicines Late-stage development MEDI8367 Early development Chronic kidney disease Oncology

Trial Population Patients Design Endpoints Status Phase I Healthy volunteers 70 SAD trial • Primary endpoints: safety and • FPCD: Q3 2020 NCT04365218 CKD 6 cohorts tolerability • Arm 1: MEDI8367 s.c. • Secondary endpoints: PK parameters, • Arm 2: placebo s.c. ADA CVRM

US

R&I

Other

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95 Approved medicines Late-stage development AZD8601 (VEGF-A modified RNA) Early development Cardiovascular disease Oncology

Trial Population Patients Design Endpoints Status Phase IIa HF Up to 33 • Arm 1: AZD8601 Dose A • Primary endpoints: safety and • FPCD: Q1 2018 NCTT03370887 • Arm 2: AZD 8601 Dose B tolerability • Data anticipated: H2 2021 • Arm 3: placebo Finland, Germany CVRM

Phase I Type 2 diabetic patients c. 60 SAD trial • Primary endpoints: safety and • FPCD: Q1 2017 NCT02935712 • Arm 1: AZD8601 tolerability • LPCD: Q3 2017 • Arm 2: placebo • Data readout: Q1 2018

Germany

R&I

Other

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96 Approved medicines Late-stage development AZD9977 (MCR modulator) Early development Heart failure Oncology

Trial Population Patients Design Endpoints Status

Phase IIb Heart failure with chronic 540 Randomised, stratified according to T2DM and eGFR (≥20 to • Primary endpoint: percent change • FPCD: Q2 2021 NCT04595370 kidney disease <30 mL/min / ≥30 to <45 mL/min / ≥45 mL/min) for 12 weeks: from baseline in UACR at 12 weeks • Data anticipated: H2 2022 • Arm 1: AZD9977 15 mg + Farxiga 10 mg • CVRM • Arm 2: AZD9977 50 mg + Farxiga 10 mg Secondary endpoints: percent change from baseline in UACR at 12 weeks to • Arm 3: AZD9977 150 mg + Farxiga 10 mg assess dose-response relationship; • Arm 4: AZD9977 150 mg dose-response relationship of • Arm 5: Farxiga 10 mg placebo, AZD9977 alone Farxiga and 3 • Arm 6: placebo doses of AZD9977 combined with 12 weeks Farxiga on UACR; safety, tolerability Trial conducted in 20 countries globally and serum potassium values; eGFR

Phase I Healthy volunteers 27 MAD trial • Primary endpoints: safety and • FPCD: Q1 2018 R&I NCT03435276 3 cohorts tolerability • LPCD: Q2 2018 • Arm 1: AZD9977 • Secondary endpoints: PK parameters • Data readout: Q3 2018 • Arm 2: placebo UK. Phase I Healthy volunteers 12 BA trial of four different oral formulations of AZD9977 and • Primary endpoints: relative • FPCD: Q2 2018 NCT03450759 influence of food bioavailability vs. oral suspension • LPCD: Q2 2018 UK. (reference) • Data readout: Q3 2018

• Secondary endpoints: PK parameters Other

Phase I HF 60 • Arm 1: AZD9977 • Primary endpoint: serum potassium • FPCD: Q4 2018 NCT03682497 • Arm 2: spironolactone • LPCD: Q1 2019

Phase I Healthy volunteers 14 DDI trial • Primary endpoints: PK parameters • FPCD: Q1 2019

NCT03843060 • Arm 1: AZD9977 • Secondary endpoints: safety and • LPCD: Q1 2019 19

• Arm 2: AZD9977 + itraconazole tolerability • Data readout: Q3 2019 -

US COVID

97 Approved medicines Late-stage development AZD9977 (MCR modulator) Early development Heart failure Oncology

Trial Population Patients Design Endpoints Status Phase I Healthy volunteers 45 JSMAD trial • Primary endpoints: safety and • FPCD: Q1 2019 NCT03801967 Single and multiple-ascending dose administration in Japanese tolerability • LPCD: Q2 2019 healthy volunteers. • Secondary endpoints: PK parameters • Data readout: Q3 2019 UK CVRM Phase I Healthy volunteers 12 BA trial • Primary endpoints: relative • FPCD: Q1 2019 NCT03804645 Investigation of four different oral formulations of AZD9977 and bioavailability vs. capsule formulation • LPCD: Q2 2019 influence of food. (reference); PK parameters • Data readout: Q3 2019 UK Phase I Renal impairment 32 • AZD9977 • Primary endpoints: PK parameters • FPCD: Q3 2020 NCT04469907 US • Secondary endpoints: safety and • Data anticipated: H2 2021

tolerability R&I Phase I Healthy volunteers 8 hADME trial • Primary endpoints: absolute • FPCD: Q1 2021 NCT04686591 • single oral dose 14C-AZD9977 bioavailability, the mass balance, rates • LPCD: Q1 2021 UK and routes of elimination • Data anticipated: H2 2021 • Secondary endpoints: safety and

tolerability

Other

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98 Approved medicines Late-stage development Zibotentan (endothelin receptor antagonist) Early development Chronic kidney disease Oncology

Trial Population Patients Design Endpoints Status Phase IIb CKD 660 Part A: 132 participants equally randomised across 4 arms: • Primary endpoint: change in log-transformed • FPCD: Q2 2021 NCT04724837 • Arm 1: zibotentan dose A + Farxiga 10 mg once daily UACR from baseline to week 12. • Data anticipated: H2 2022 • Arm 2: zibotentan dose A once daily • Secondary endpoints: change in log-transformed • Arm 3: Farxiga 10 mg once daily UACR from baseline to week 12; change in blood CVRM • Arm 4: placebo once daily pressure from baseline (Visit 2) to week 12; least Part B: 528 participants equally randomised across 6 arms: squares mean change of UACR at week 12 from • Arm 1: zibotentan dose C + Farxiga 10 mg once daily the 3 Zibo/Dapa dose groups and the Farxiga • Arm 2: zibotentan dose B + Farxiga 10 mg once daily monotherapy group; change in eGFR from baseline to week 1, week 12 and week 14; change • Arm 3: zibotentan dose A + Farxiga 10 mg once daily in eGFR from week 1 to week 12. • Arm 4: zibotentan dose A once daily • Arm 5: Farxiga 10 mg once daily • Arm 6: placebo once daily R&I

Global

Other

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99 Approved medicines Late-stage development MEDI5884 (cholesterol modulation) Early development Cardiovascular disease Oncology

Trial Population Patients Design Endpoints Status Phase IIa Adults with stable 133 5 dose cohorts • Primary endpoints: safety profile in terms of AEs, vital signs, • FPCD: Q4 2017 NCT03351738 CHD • Arm 1: MEDI5884 ECG, lab variables; Changes in HDL-C over time, PK, • Data readout: Q4 2018

• Arm 2: placebo immunogenicity, and Apolipoprotein B

CVRM

R&I

Other

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100 Approved medicines Late-stage development MEDI6570 Early development Cardiovascular & metabolic diseases Oncology

Trial Population Patients Design Endpoints Status Phase IIb Post MI 792 Evaluation of anti-inflammatory potential • Primary endpoints: efficacy and safety • FPCD: Q4 2020 NCT04610892 and effect on surrogates for • Data anticipated: 2022+ atherosclerotic and heart failure (HF) events CVRM • Arm 1: High MEDI6570 dose • Arm 2: Medium MEDI6570 dose • Arm 3: Low MEDI6570 dose • Arm 4: placebo US, Canada, Hungary, Japan, Czech Republic, Italy, Spain, Netherlands, Poland, UK, Australia, Russia

Phase I Atherosclerotic 88 SAD followed by MAD trial • Primary endpoints: safety and tolerability • FPCD: Q4 2018 R&I NCT03654313 cardiovascular • MEDI6570 • LPCD: Q3 2020

disease • Data anticipated: H2 2021

Other

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101 Approved medicines Late-stage development AZD0449 (inhaled JAK-1 inhibitor) Early development Asthma Oncology

Trial Population Patients Design Endpoints Status Phase I Healthy subjects and patients 130 SAD/MAD/Bridge trial • Primary endpoints: safety and • FPCD: Q4 2018 NCT03766399 with mild asthma Part 1 SAD tolerability • Data anticipated: H2 2021 • •

Arm 1: AZD0449 i.v. Secondary endpoints: PK parameters, CVRM • Arm 2: placebo i.v. FENO Part 2 MAD • Arm 1: Inhaled AZD0449 • Arm 2: Inhaled placebo Part 3 bridge • Arm 1: AZD0449 (DPI formulation) • Arm 2: placebo

UK and NZ

R&I

Other

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102 Approved medicines Late-stage development AZD1402 (IL4 receptor alpha antagonist) Early development Asthma Oncology

Trial Population Patients Design Endpoints Status Phase IIa Patients with asthma on 405 Randomised, placebo-controlled, double-blinded, multicentre, • Part 1 primary endpoints: safety and • FPCD: Q2 2021 NCT04643158 medium dose inhaled 2-part study. tolerability, PK • Data anticipated: H2 2022 Partnered corticosteroids Part 1 population with asthma controlled on medium dose ICS- • Part 2 primary endpoint: change in LABA FEV1 CVRM Part 1a • Arm 1: AZD1402 Dose 1 (low) (DPI) • Arm 2: AZD1402 Dose 2 (DPI) • Arm 3: placebo Part 1b • Arm 1: AZD1402 Dose 3 (high) (DPI) • Arm 2: placebo Part 2 population uncontrolled on medium dose ICS-LABA R&I • Arm 1: AZD1402 Dose 1 (DPI) • Arm 2: AZD1402 Dose 2 (DPI) • Arm 3: AZD1402 Dose 3 (DPI) • Arm 4: placebo Ukraine, Australia, Germany Phase Ib Patients with mild asthma 84 PoM trial. A dose-escalating, single blind trial of multiple • Primary endpoints: safety and • FPCD: Q3 2018 NCT03574805 doses of PRS-060 administered by oral Inhalation In tolerability • LPCD: Q3 2020

Partnered subjects with mild asthma • Secondary endpoints: PK parameters, Other Australia potential immunogenicity, change in

FENO

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103 Approved medicines Late-stage development MEDI3506 (IL33 ligand mAb) Early development COPD, atopic dermatitis, asthma Oncology

Trial Population Patients Design Endpoints Status

Phase II Adult subjects with atopic 152 Randomised, blinded, placebo-controlled trial • Primary endpoint: change from • FPCD: Q4 2019 NCT04212169 dermatitis • Arm 1: MEDI3506 s.c. baseline at week 16 in Eczema Area • Data anticipated: H1 2022 • and Severity Index (EASI) score

Arm 2: MEDI3506 s.c. CVRM • • Arm 3: MEDI3506 s.c. Secondary endpoints: safety and other efficacy measures • Arm 4: placebo s.c. US, Australia, Germany, Poland, UK & Spain

Phase II Adult participants with 278 Randomised, double-blind, placebo-controlled trial • Primary endpoint: change from • FPCD: Q4 2020 NCT04570657 uncontrolled moderate to • Arm 1: MEDI3506 Dose 1 s.c. baseline at week 16 in FEV1 • Data anticipated: H2 2022 severe asthma • Arm 2: MEDI3506 Dose 2 s.c. • Secondary endpoints: safety and other efficacy measures • ARM 2: placebo s.c. R&I US, Argentina, Germany, Hungary, Poland and South Africa

Phase II Adult subjects COPD and 322 Randomised, double-blind, placebo-controlled, parallel group, • Primary endpoint: change from • FPCD: Q1 2021 NCT04631016 chronic bronchitis proof of concept trial baseline at week 12 in FEV1 • Data anticipated: 2022+ • Arm 1: MEDI3506 s.c. • Secondary endpoints: safety and other • ARM 2: placebo s.c. efficacy measures US, Australia, Canada, Czech Republic, Denmark, Germany,

Hungary, Israel, Netherlands, New Zealand, Poland, South Other

Africa, Spain & UK

19

- COVID

104 Approved medicines Late-stage development AZD9567 (SGRM, oral) Early development Immunology Oncology

Trial Population Patients Design Endpoints Status

Phase II Patients with type 2 diabetes 42 • Arm 1: 72mg AZD9567 + 40mg prednisolone • Primary endpoint: change in glucose • FPCD: Q4 2020 NCT04556760 mellitus • Arm 2: 40mg AZD9567 + 20mg prednisolone AUC (0-4) versus baseline compared • LPCD: Q2 2021 • Arm 3: placebo + 5mg prednisolone to prednisolone following a • Data readout: H2 2021

standardised MMTT CVRM

R&I

Other

19

- COVID

105 Approved medicines Late-stage development MEDI0618 (PAR2 antagonist mAb) Early development Osteoarthritis pain Oncology

Trial Population Patients Design Endpoints Status

Phase I Painful osteoarthritis of the knee 64 (healthy SAD trial • Primary endpoints: safety and • FPCD: Q4 2019 NCT02508155 volunteers) • Arm 1: MEDI0618 i.v. tolerability • Data anticipated: H2 2021 • • Arm 2: placebo i.v. Secondary endpoint: PK CVRM • Arm 3: MEDI0618 s.c • Arm 4: placebo s.c

Europe only

R&I

Other

19

- COVID

106 Approved medicines Late-stage development MEDI1341 (alpha-synuclein mAb) Early development Parkinson’s disease Oncology

Trial Population Patients Design Endpoints Status Phase I Healthy volunteers 48 SAD trial • Primary endpoints: safety and • FPCD: Q4 2017 NCT03272165 • Arm 1: MEDI1341 i.v. tolerability • LPCD: Q4 2020 • Arm 2: placebo i.v. • Secondary endpoints: PK, PD • Data anticipated: H2 2021 US only CVRM

Phase I Parkinson's Disease 36 MAD trial • Primary endpoints: safety and • FPCD: Q3 2020 NCT04449484 • Arm 1: MEDI1341 i.v. tolerability • Data anticipated: 2022+ • Arm 2: placebo i.v. • Secondary endpoints: PK, PD

US only

R&I

Other

19

- COVID

107 Approved medicines Late-stage development AZD4041 (orexin 1 receptor antagonist) Early development Opioid use disorder Oncology

Trial Population Patients Design Endpoints Status Phase I Healthy volunteers 48 Randomised, double blind, SAD trial • Primary endpoints: safety and • FPCD: Q4 2019 NCT04076540 • Arm 1: AZD4041 tolerability • Data anticipated: H2 2021 Partnered with Eolas • Arm 2: placebo • Secondary endpoints: PK, PD Therapeutics Inc and US only CVRM

NIH

R&I

Other

19

- COVID

108 Approved medicines Late-stage development MEDI7352 (NGF TNF bispecific mAb) Early development Osteoarthritis pain Oncology

Trial Population Patients Design Endpoints Status Phase IIb Painful osteoarthritis of the knee 300 MAD trial • Primary endpoint: dose response • FPCD: Q1 2021 NCT04675034 • Arm 1: MEDI7352 s.c • Secondary endpoints: safety, • Data anticipated: H2 2022 • Arm 2: placebo s.c tolerability, PK, PD, ADA Global (8 countries) CVRM

Phase II Painful diabetic neuropathy 271 MAD trial • Primary endpoint: dose response • FPCD: Q4 2018 NCT03755934 • Arm 1: MEDI7352 i.v. • Secondary endpoints: safety, • Data anticipated: H2 2022 • Arm 2: placebo i.v. tolerability, PK, PD Europe only

Phase I Painful osteoarthritis of the knee 160 SAD & MAD trial • Primary endpoints: safety and • FPCD: Q1 2016 R&I NCT02508155 • Arm 1: MEDI7352 i.v. tolerability • LPCD: Q4 2020 • Arm 2: placebo i.v. • Secondary endpoints: PK, PD • Data readout: Q2 2021 • Arm 3: MEDI7352 s.c • Arm 4: placebo s.c Europe only Phase I Healthy volunteers 20 MAD trial • Primary endpoints: safety and • FPCD: Q2 2021 NCT04770428 Japanese and Caucasian • Arm 1: MEDI7352 s.c tolerability • Data anticipated: H2 2021 • Arm 2: placebo s.c • Secondary endpoints: PK, PD, ADA

Europe only Other

19

- COVID

109 Approved medicines Late-stage development MEDI3902 (Anti-Pseudomonas A mAb) Early development Infections Oncology

Trial Population Patients Design Endpoints Status Phase II Intubated ICU 195 SAD trial • Primary endpoints: safety and efficacy • FPCD: Q2 2016 NCT02696902 • Arm 1: MEDI3902 i.v. • Data readout: Q4 2020

• Arm 2: placebo i.v.

CVRM

R&I

Other

19

- COVID

110 List of abbreviations

14C Radioactive isotope of carbon, Carbon 14 CHF Chronic heart failure FGFR Fibroblast growth factor receptor 1L, 2L, 3L 1st, 2nd or 3rd line CKD Chronic kidney disease FLAP 5-lipoxygenase-activating protein 5-FU 5-fluorouracil CLL Chronic lymphocytic leukaemia FPDC First patient commenced dosing A2AR Adenosine A2A receptor CMAX Maximum observed plasma concentration FPG Fasting plasma glucose ACQ Asthma control questionnaire C-MET Tyrosine-protein kinase Met GA Gestational age ACR American college of rheumatology response scoring system CNS Central nervous system GBM Glioblastoma ADA Anti-drug antibodies COPD Chronic obstructive pulmonary disease gBRCAm or ADC Antibody-drug conjugate CR Complete response tBRCAm Germline or tumour (somatic) BRCA mutation ADP Adenosine diphosphate CRC Colorectal cancer GEJ Gastric/gastro-oesophogeal junction AE Adverse Event CrCl Creatinine clearance GFF Glycopyrronium and formoterol fumarate AI Auto-injector CRR Complete response rate GLP-1 Glucagon-like peptide-1 AKT Protein kinase B CTC Circulating tumour cell GMFRs Geometric mean fold rises ALK Anaplastic large-cell lymphoma kinase CTLA-4 Cytotoxic T-lymphocyte–associated antigen 4 GMTs Geometric mean titers APFS Accessorised pre-filled syringe CV Cardiovascular hADME Human mass balance AQLQ Asthma quality of life questionnaire CVOT Cardiovascular outcomes trial HAI Haemagglutination-inhibition AS Albuterol sulphate CVRM Cardiovascular renal and metabolism HbA1c Haemoglobin A1c ATM Ataxia-telangiectasia mutated kinase CXCR2 C-X-C Motif chemokine receptor 2 HCC Hepatocellular carcinoma ATR Ataxia telangiectasia and rad3-related protein DB Double blind HD High dose AUC Area under curve DC Disease control HDL-C High-density lipoprotein cholesterol B7RP B7-related protein-1 DCR Disease control rate HER2 Human epidermal growth factor receptor 2 BA Bioavailability DDI Drug-drug Interaction HF Heart failure BAFF B-cell activating factor dECG Differentiated electrocardiogram HFpEF Heart failure with preserved ejection fraction BCG Bacillus Calmette–Guérin DFS Disease free survival HFrEF Heart failure with reduced ejection fraction BCMA B-cell maturation antigen DLBCL Diffuse large B-cell lymphoma HGFR Met/hepatocyte growth factor receptor BDA Budesonide albuterol DLT Dose-limiting toxicity HGSC High grade serous carcinoma BFF Budesonide and formoterol fumarate DMARDs Disease-modifying antirheumatic drugs hHF Hospitalisation for heart failure BGF Budesonide, glycopyrronium and formoterol fumarate DNA Deoxyribonucleic acid HIF-PHI Hypoxia inducible factor - prolyl hydroxylase inhibitor BICR Blinded independent central review DoCR Durability of complete response HNSCC Head and neck squamous-cell carcinoma BID Bis in die (twice per day) DoR Duration of response HPV Human papillomavirus BIG Big ten cancer research consortium DPI Dry powder inhaler HRD Homologous recombination deficiency BMD Bone mineral density DXA Dual energy X-ray absorptiometry HRRm Homologous recombination repair mutation BMI Body mass index EBRT External beam radiation therapy i inhibitor BRCAwt Breast cancer wild-type gene ECG Electrocardiogram IA Investigator-assessed BRD4 Bromodomain-containing protein 4 EFS Event-free survival ICS Inhaled corticosteroid BTC Biliary tract carcinoma eGFR Estimated glomerular filtration rate ICU Intensive care unit BTK Bruton's tyrosine kinase EGFR Epidermal growth factor receptor IDFS Invasive disease-free survival CA-125 Cancer antigen 125 ER Oestrogen receptor IL Interleukin CAD Coronary artery disease ERK Extracellular signal-regulated kinase i.m. Intramuscular CBR Clinical benefit rate ESR Externally sponsored trial IRC Independent review committee CCL20 Chemokine (C-C motif) ligand 20 ESR1 Oestrogen receptor 1 ISS Investigator-sponsored studies CD Cluster of differentiation ESSC Esophageal squamous cell carcinoma i.v. Intraveneous CDK Cyclin-dependent kinase ET Endocrine therapy J-SD Japanese single dose CE Clinically evaluable FDC Fixed-dose combination Ki67 Protein that is encoded by the MKI67 gene in human CHD Coronary heart disease FeNO Fractional nitric oxide concentration in exhaled breath LAAB Long acting antibody Chemo Chemotherapy FEV Forced-expiratory volume 111 List of abbreviations

LABA Long -acting beta agonist PARP Poly ADP ribose polymerase SAD Single ascending dose LAMA Long-acting muscarinic agonist PASI Psoriasis area severity index SAE Serious adverse event LCAT Lecithin-cholesterol acyltransferase PBD Pyrrolobenzodiazepine SBRT Stereotactic body radiation therapy LCM Lifecycle management pCR Pathological complete response s.c. Subcutaneous LN Lupus nephritis PD Pharmacodynamics SCLC Small cell lung cancer LOCS III Lens opacities classification system III PD-1 Programmed cell death protein 1 SD Stable disease LPCD Last patient commenced dosing PDAC Pancreatic ductal adenocarcinoma SERD Selective oestrogen receptor degrader LV Left ventricle PDE4 Phosphodiesterase type 4 SGLT2 Sodium-glucose transport protein 2 m Mutation PD-L1 Programmed death-ligand 1 SGRM Selective glucocorticoid receptor modulator mAb Monoclonal antibody PET Positron-emission tomography SGRQ Saint George respiratory questionnaire MABA Muscarinic antagonist-beta2 agonist PFS Progression free survival SJC Swollen joint count MACE Major adverse cardiac events PgR Progesterone receptor SLE Systemic lupus erythematosus MAD Multiple ascending dose PI3K Phosphoinositide 3-kinase SLL Small lymphocytic lymphoma MCC Mucociliary clearance PIK3CA Phosphatidylinositol 3 kinase catalytic alpha gene SMAD Single and multiple ascending dose trial MCL Mantle cell lymphoma PK Pharmacokinetics SoC Standard of care MCL1 Myeloid leukemia cell differentiation protein 1 PLL Prolymphocytic leukaemia sPGA Static physicians global assessment score mCRPC Metastatic castrate-resistant prostate cancer pMDI Pressurised metered dose inhaler STAT3 Signal transducer and activator of transcription 3 MD Medium dose PN Plexiform neurofibromas sUA Serum uric acid MDI Metered-dose inhaler POC Proof of concept T2DM Type 2 Diabetes Mellitus MDS Myelodysplastic syndrome POM Proof of mechanism T790M Threonine 790 substitution with methionine MEK Mitogen-activated protein kinase pPCI Primary percutaneous coronary intervention TACE Transarterial Chemoembolization MET Tyrosine-protein kinase Met PR Partial response TEAEs Treatment-emergent adverse events MI Myocardial infarction pre-BD Pre-bronchodilator TID Ter in die (three times a day) MMT Mixed meal test PRO Patient reported outcome TJC Tender joint count MPO Myeloperoxidase PRR Recurrent platinum resistant TKI Tyrosine kinase Inhibitor mPR Major pathological response PS Propensity score TLR Toll-like receptor 9 MRI Magnetic resonance imaging PSA Prostate-specific antigen TNBC Triple negative breast cancer MTD Maximum tolerated dose PSC Pulmonary sarcomatoid carcinoma TNF Tumour necrosis factor NaC Sodium channel PSMA Prostate-specific membrane antigen TSLP Thymic stromal lymphopoietin NCI National cancer institute (US) PTEN Phosphatase and tensin homolog gene TTF Time to treatment failure NCPV Noncalcified plaque volume Q2,3,4,8W Quaque (every) two, three... weeks TTNT Time to next therapy NF1 Neurofibromatosis type 1 QD Quaque in die (once a day) TTP Time to tumour progression NGF Nerve growth factor QID Quarter in die (four times a day) UACR Urine albumin creatinine ratio NHL Non-Hodgkin’s lymphoma QOD Quaque altera die (every other day) UMEC Umeclidinium NIH National Institute of Health (US) QoL Quality of Life URAT1 Uric Acid Transporter 1 NKG2a Natural killer cell C-type lectin receptor G2A QTcF Corrected QT interval by Fredericia VEGF Vascular endothelial growth factor NME New molecular entity RA Rheumatoid Arthritis YTE Triple-amino-acid (M252Y/S254T/T256E [YTE]) substitution NRG National clinical trials network in oncology (US) RAAS Renin–angiotensin–aldosterone system NSCLC Non-small cell lung cancer RECIST Response evaluation criteria in solid tumours OCS Oral corticosteroid RFS Relapse-free survival OD Once daily rhLCAT Recombinant human Lecithin-cholesterol acyltransferase OGTT Oral glucose tolerance test RORγ Related orphan receptor gamma OR Objective response r/r Relapsed/refractory ORR Objective response rate RT Radiation therapy OS Overall survival SABA Short-acting beta2-agonist 112 Clinical trials appendix

Q1 2021 results update