H1 2021 Results Clinical Trials Appendix PDF 2769KB

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H1 2021 Results Clinical Trials Appendix PDF 2769KB 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
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