Clinical Trials Appendix Q1 2020 Results Update Movement Since Q4 2019 Update
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Clinical trials appendix Q1 2020 results update Movement since Q4 2019 update New to Phase I New to Phase II New to Pivotal trial New to registration NME Lifecycle management AZD2373 Enhertu# DESTINY-Gastric02 Podocyte health nephropathy HER2 targeting antibody drug conjugate HER2- positive gastric cancer that cannot be surgically AZD7648# removed or has spread DNAPK haematological and solid tumours IPH5201# CD39 solid tumours Removed from Phase I Removed from Phase II Removed from Phase III Removed from registration NME NME NME MEDI3902 Imfinzi# + tremelimumab DANUBE Koselugo# (selumetinib) SPRINT¶ 1 Psl/PcrV bispecific mAb prevention of nosocomial PD-L1 mAb + CTLA-4 mAb 1st-line bladder MEK inhibitor paediatric neurofibromatosis type-1 Pseudomonas aeruginosa pneumonia cancer Lifecycle management Imfinzi# + SoC CASPIAN 1 PD-L1 mAb + SoC 1st-line extensive-stage small cell lung cancer 2 ¶ Registrational Phase II/III trial # Partnered and/or in collaboration 1 Submission approved Q1 2020 new molecular entity (NME)1 pipeline Phase I Phase II Phase III Under review 20 new molecular entities 25 new molecular entities 7 new molecular entities 0 new molecular entities AZD0466 capivasertib+chemotherapy Imfinzi#+RT (platform) CLOVER adavosertib# Imfinzi#+oleclumab BCL2/xL haematological and solid CAPItello-290 PD-L1+RT HNSCC NSCLC SCLC Wee1 ovarian cancer, solid tumours PD-L1+CD73 solid tumours tumours AKT+chemotherapy mTNBC 1L AZD2811 Imfinzi#+/-tremelimumab+chemo AZD1390 Imfinzi#+tremelimumab Imfinzi#+tremelimumab Aurora solid tumours, haematological POSEIDON glioblastoma PD-L1+CTLA-4 solid tumours PD-L1+CTLA-4 gastric cancer malignancies PD-L1+/-CTLA-4+SoC 1L NSCLC Imfinzi#+tremelimumab+chemo Imfinzi#+tremelimumab Imfinzi#+/-tremelimumab+CRT AZD4573 AZD4635 PD-L1+CTLA-4 1L PDAC oesophageal PD-L1+CTLA-4 biliary tract ADRIATIC CDK9 haematological malignancies A2aR inhibitor prostate cancer SCLC oesophageal PD-L1+/-CTLA-4+CRT LS-SCLC AZD5153 Imfinzi+Koselugo (selumetinib)# AZD9833 Imfinzi+Lynparza# BAYOU Imfinzi#+tremelimumab HIMALAYA BRD4 haematological and solid PD-L1+MEK solid tumours SERD ER+ breast PD-L1+PARP bladder PD-L1+CTLA-4 1L HCC tumours AZD5991 IPH5201# capivasertib# Lynparza#+adavosertib# Imfinzi#+tremelimumab KESTREL MCL1 haematological malignancies CD39 solid tumours AKT breast PARP+Wee1 solid tumours PD-L1+CTLA-4 1L HNSCC AZD7648# Imfinzi#+tremelimumab+SoC NILE MEDI1191 capivasertib# Lynparza#+AZD6738 VIOLETTE DNAPK solid and haematological PD-L1+CTLA-4+SoC 1L urothelial IL12 mRNA solid tumours AKT prostate PARP+ATR breast tumours cancer Imfinzi# (platform) COAST Lynparza#+Imfinzi MEDIOLA Lynparza#+Imfinzi#+bevacizumab AZD9496 MEDI2228 PD-L1+multiple novel ONC therapies PARP+PD-L1 ovarian breast gastric DUO-O SERD ER+ breast BCMA ADC multiple myeloma NSCLC SCLC PARP+PD-L1+VEGF 1L ovarian MEDI5083 Imfinzi# (platform) NeoCOAST Calquence+ceralasertib MEDI5752 CD40 ligand fusion protein solid PD-L1++multiple novel ONC therapies BTK+ATR haematological tumours PD-1/CTLA-4 solid tumours tumours NSCLC Calquence+danvatirsen MEDI5395 Imfinzi#+AZD4635 oleclumab+AZD4635 BTK+STAT3 haematological rNDV GMCSF solid tumours PD-L1+A2aR prostate cancer CD73+A2aR prostate cancer malignancies Imfinzi#+AZD5069 or Imfinzi#+ oleclumab+chemo or Imfinzi#+ Imfinzi#+adavosertib# oleclumab+Tagrisso danvatirsen# PD-L1+(CXCR2 or oleclumab+chemo CD73+chemo or PD-L1+Wee1 solid tumours CD73+EGFR EGFRm NSCLC STAT3) HNSCC bladder NSCLC PD-L1+CD73+chemo pancreatic Imfinzi#+Lynparza# ORION Tagrisso combo# TATTON PD-L1+PARP 1L mNSCLC EGFR+PD-L1/MEK/MET NSCLC Tagrisso+savolitinib# SAVANNAH Imfinzi#+MEDI0457# EGFR+MET advanced EGFRm PD-L1+DNA HPV vaccine HNSCC NSCLC 1 Includes novel combinations and additional indications for assets Imfinzi#+monalizumab# where the lead is not yet launched PD-L1+NKG2a solid tumours 3 # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial Oncology Precision medicine approach being explored Q1 2020 new molecular entity (NME)1 pipeline Phase I Phase II Phase III Under review 17 new molecular entities 20 new molecular entities 4 new molecular entities 0 new molecular entities cotadutide AZD0284 AZD8233 abediterol# anifrolumab# TULIP GLP-1/glucagon type-2 diabetes / RORg psoriasis / respiratory hypercholesterolemia cardiovascular LABA asthma / COPD Type I IFN receptor SLE obesity / NASH nirsevimab# AZD0449 AZD9977 anifrolumab# MEDI3506 RSV mAb-YTE passive RSV Inhaled JAK inhibitor asthma MCR cardiovascular Type I IFN receptor SLE SC Diabetic kidney disease immunisation AZD1402# MEDI0618# anifrolumab# MEDI3506 PT027 inhaled IL-4Ra asthma PAR2 antagonist mAb OA pain Type I IFN receptor lupus nephritis IL33 AD / COPD ICS/SABA asthma AZD2373 MEDI1341# AZD4831 MEDI5884# tezepelumab# NAVIGATOR SOURCE Podocyte health nephropathy alpha synuclein parkinson's disease MPO HFpEF cholesterol modulation cardiovascular TSLP severe uncontrolled asthma AZD2693 MEDI1814# AZD5718 MEDI6012 nonalcoholic steatohepatitis amyloidβ alzheimer's disease FLAP coronary artery disease LCAT cardiovascular AZD4041# MEDI7352 MEDI5117# China velsecorat (AZD7594) orexin 1 receptor antagonist opioid use NGF/TNF OA pain / painful diabetic IL6 YTE rheumatoid arthritis Inhaled SGRM asthma / COPD disorder neuropathy AZD5634 MEDI6570 AZD7986# suvratoxumab inhaled ENaC cystic fibrosis LOX-1 CV disease DPP1 COPD α-Toxin Staphylococcus pneumonia AZD6615 MEDI7219 AZD8601# tezepelumab# hypercholesterolemia CV disease anti-diabetic type-2 diabetes VEGF-A cardiovascular TSLP atopic dermatitis AZD8154 navafenterol (AZD8871)# tezepelumab# Inhaled PI3Kgd asthma MABA COPD TSLP COPD AZD9567 verinurad SGRM RA / respiratory URAT-1 chronic kidney disease 1 Includes novel combinations and additional indications for assets where the lead is not yet launched Precision medicine approach being explored 4 # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial BioPharmaceuticals Q1 2020 lifecycle management (LCM)1 pipeline Phase I Phase II Phase III Under review 1 Project 9 Projects 24 Projects 1 Project Imfinzi#+CRT PACIFIC-5 (China) Imfinzi#+azacitidine# Enhertu# Calquence# Lynparza# PROfound PD-L1+CRT locally-advanced stage III PD-L1+azacitidine MDS ADC NSCLC BTK inhibitor 1st line MCL PARP prostate cancer NSCLC Imfinzi#+CTx neoadjuvant AEGEAN Enhertu# DESTINY-CRC-01 Calquence# PD-L1+CTx locally-advanced stage I-III ADC colorectal cancer BTK inhibitor r/r CLL, high risk NSCLC Calquence#+venetoclax+ Imfinzi#+CTx NIAGARA Enhertu# DESTINY-Gastric02 obinutuzumab PD-L1+CTx muscle invasive bladder ADC gastric BTK+BCL-2+anti-CD20 1st line CLL cancer Imfinzi# Enhertu# DESTINY-Breast02 Imfinzi#+CTx TOPAZ-1 PD-L1 solid tumours ADC breast PD-L1+CTx 1L biliary tract cancer Imfinzi# (platform) BEGONIA Enhertu# DESTINY-Breast03 Imfinzi#+VEGF EMERALD-2 PD-L1 1L mTNBC ADC breast PD-L1+VEGF adjuvant HCC Imfinzi# (platform) MAGELLAN Enhertu# DESTINY-Breast04 Imfinzi#+VEGF+TACE EMERALD-1 PD-L1 1L mNSCLC ADC breast PD-L1+VEGF+TACE locoregional HCC Imfinzi+FOLFOX+bevacizumab (platform) Enhertu¶# DESTINY-Gastric01 Lynparza# OlympiA COLUMBIA1 PD-L1+chemo+VEGF+multiple ADC gastric PARP gBRCA adjuvant breast novel ONC therapies 1L MSS-CRC Imfinzi# CALLA Lynparza# (basket) MK-7339-002 / LYNK002 PD-L1 adj. locally advanced cervical Lynparza# SOLO-3 PARP HRRm cancer PARP BRCAm PSR ovarian cancer Lynparza#+cediranib CONCERTO Imfinzi# PEARL Lynparza+abiraterone# PROpel PARP+VEGF recurrent Pt-R ovarian PD-L1 1L metastatic NSCLC PARP+NHA prostate cancer Imfinzi# post-SBRT PACIFIC-4 Tagrisso ADAURA PD-L1 post-SBRT stage I/II NSCLC EGFR adj. EGFRm NSCLC Imfinzi# POTOMAC Tagrisso LAURA PD-L1 non muscle invasive bladder EGFRm locally advanced unresectable cancer NSCLC Imfinzi#+CRT PACIFIC-2 Tagrisso+chemo FLAURA2 PD-L1+CRT NSCLC EGFR+chemo 1L adv EGFRm NSCLC 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 Q1 2020 lifecycle management (LCM)1 pipeline Phase I Phase II Phase III Under review 0 Projects 2 Projects 10 Projects 4 Projects Breztri Brilinta/Brilique HESTIA Brilinta/Brilique THEMIS LABA/LAMA/ICS asthma P2Y12 paeds w/ sickle cell P2Y12 diabetes & CAD outcomes roxadustat# Brilinta/Brilique THALES Farxiga/Forxiga DAPA-HF HIF-PH inhibitor chemo induced P2Y12 stroke SGLT2 HFrEF anaemia Farxiga/Forxiga Dapa-CKD Nexium (CN only) SGLT2 CKD stress ulcer prophylaxis Farxiga/Forxiga DELIVER Symbicort SYGMA SGLT2 HFpEF as needed in mild asthma Farxiga/Forxiga DETERMINE- Preserved SGLT2 HFpEF Farxiga/Forxiga DETERMINE-Reduced SGLT2 HFrEF Fasenra MANDARA IL-5R EGPA Fasenra# OSTRO, ORCHID IL-5R nasal polyposis Fasenra# RESOLUTE IL-5R COPD roxadustat# HIFPH anaemia MDS 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 PT027 asthma tezepelumab asthma NAVIGATOR Imfinzi + tremelimumab HCC Imfinzi + tremelimumab + CRT LDS-SCLC Fasenra severe asthma (China) HIMALAYA ADRIATIC anifrolumab SLE Imfinzi + tremelimumab HNSCC Imfinzi + tremelimumab+ SoC urothelial nirsevimab passive RSV immunisation TULIP KESTREL NILE Imfinzi +/- tremelimumab SCLC Enhertu Imfinzi +/- tremelimumab NSCLC capivasertb + CTx 1L mTNBC Lynparza +Imfinzi + bevacizumab ovarian NME CASPIAN (China) DESTINY-Breast01 (EU) POSEIDON CAPItello-290