Slide 1: Clinical trials appendix: Year-to-date and Q3 2020 results update
Clinical trials appendix Year-to-date and Q3 2020 results update
Slide 2: Movement since Q2 2020 update
Movement since Q2 2020 update New to Phase I New to Phase II New to Pivotal trial New to registration NME Additional indication Additional indication NME AZD7442 cotadutide capivasertib# + abiraterone CAPItello-281 anifrolumab TULIP 1 & TULIP 2 [US & EU] 1 COVID-19 mAb combination GLP-1/glucagon dua
Slide 3: Q3 2020 new molecular entity (NME) pipeline
Q3 2020 new molecular entity (NME)1 pipeline Phase I Phase II Phase III 20 New Molecular Entities 25 New Molecular Entities 10 New Molecular Entities AZD0466 Imfinzi#+adavosertib# adavosertib# Imfinzi#+AZD4635 Imfinzi+Lynparza# BAYOU capivasertib#+abiraterone CAPItello-281 BCL2/xL haematological and
Slide 4: Q3 2020 new molecular entity (NME) pipeline
Q3 2020 new molecular entity (NME)1 pipeline Phase I Phase II Phase III Under Review 17 New Molecular Entities 21 New Molecular Entities 5 New Molecular Entities 1 New Molecular Entity MEDI3506 AZD0284 AZD8154 abediterol# AZD1222# anifrolumab# TULIP 1 & TULIP 2 IL-33 AD / COPD / asthma / RORg psoria
Slide 5: Q3 2020 lifecycle management (LCM) pipeline
Q3 2020 lifecycle management (LCM)1 pipeline Phase I Phase II Phase III Under Review 1 Project 8 Projects 26 Projects 1 Project Calquence CALAVI-US & CALAVI- Imfinzi#+azacitidine# Calquence# Imfinzi# PEARL Imfinzi#+VEGF EMERALD-2 Tagrisso ADAURA RoW PD-L1+azacitidine MDS BTK inhibitor 1st line MCL P
Slide 6: Q3 2020 lifecycle management (LCM) pipeline
Q3 2020 lifecycle management (LCM)1 pipeline Phase I Phase II Phase III Under Review 0 Projects 2 Projects 10 Projects 2 Projects Breztri Farxiga/Forxiga Dapa-CKD Brilinta/Brilique THALES LABA/LAMA/ICS asthma SGLT2 CKD P2Y12 stroke roxadustat# Farxiga/Forxiga DELIVER Symbicort SYGMA HIF-PH inhibitor
Slide 7: Estimated key regulatory submission acceptances
Estimated key regulatory submission acceptances brazikumab crohns disease capivasertib + fulvestrant locally advanced or mBC Fasenra CAPItello-291 severe asthma (China) capivasertb + CTx 1L mTNBC nirsevimab CAPItello-290 passive RSV immunisation capivasertb + abiraterone PTEN deficient mHSPC AZD7442
Slide 8: Designations
Designations 5 17 12 33 27 Accelerated approvals Breakthrough / PRIME1 / Sakigake2 Fast Track Priority Review / RTOR3 Orphan Lynparza ovarian cancer SOLO-2 (US) Tagrisso EGFRm T790M NSCLC (US) MEDI3902 Psl-PcrV pneumo Px (US) Tagrisso EGFRm T790M NSCLC (JP) Lynparza ovarian cancer SOLO-2 (US) Tagris
Slide 9: Oncology - approved medicines and late-stage pipeline
Oncology - approved medicines and late-stage pipeline
Slide 10: Oncology: Tagrisso NSCLC
Approved medicines Oncology Late-stage development Tagrisso (highly-selective, irreversible EGFRi) Early development NSCLC Trial Population Patients Design Endpoints Status CVRM Phase III Adjuvant EGFRm NSCLC 682 • Arm 1: Tagrisso QD following complete tumour resection, with • Primary endpoint: DFS
Slide 11: Oncology: Tagrisso NSCLC, combinations
Approved medicines Oncology Late-stage development Tagrisso (highly-selective, irreversible EGFRi) Early development NSCLC, combinations Trial Population Patients Design Endpoints Status CVRM Phase III Neoadjuvant EGFRm NSCLC 351 Arm 1: placebo plus plus pemetrexed/carboplatin or • Primary endpoint:
Slide 12: Oncology: Imfinzi NSCLC, early disease
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development NSCLC, early disease Trial Population Patients Design Endpoints Status CVRM Phase III Completely resected 332 • Arm 1: Imfinzi + SoC chemo Primary endpoint: • Initiating MERMAID-1 Stage II and III NSCLC • Arm 2:
Slide 13: Oncology: Imfinzi +/- treme, lung cancer advanced
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development Lung cancer, advanced disease Trial Population Patients Design Endpoints Status CVRM Phase III NSCLC 1L 650 • Arm 1: Imfinzi Q4W Primary endpoint: • FPCD: Q1 2017 PEARL • Arm 2: chemothera
Slide 14: Oncology: Imfinzi other cancers, early disease
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development Other cancers, early disease Trial Population Patients Design Endpoints Status CVRM Phase III Non-muscle invasive bladder 975 • Arm 1: BCG (Induction + maintenance) Primary endpoints: • FPCD: Q2 2018 POTOMAC can
Slide 15: Oncology: Imfinzi +/- treme other cancers advanced
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development Other cancers, advanced disease Trial Population Patients Design Endpoints Status CVRM Phase III Bladder cancer 1L 885 • Arm 1: Imfinzi + tremelimumab + SoC Primary endpoints: • FPCD: Q4 2
Slide 16: Oncology: Imfinzi +/- treme other cancers advanced
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development Other cancers, advanced disease Trial Population Patients Design Endpoints Status CVRM Phase III Advanced solid malignancies 1,200 • Arm 1: Imfinzi • Primary endpoint: safety • FPCD: Q2 20
Slide 17: Oncology: Lynparza other cancers
Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development Other cancers Trial Population Patients Design Endpoints Status CVRM Phase III BRCAm adjuvant breast 1,836 • Arm 1: Lynparza BiD 12 month duration • Primary endpoint: invasive disease-free • FPCD: Q2 2014
Slide 18: Oncology: Lynparza Imfinzi combinations
Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development Imfinzi combinations Trial Population Patients Design Endpoints Status CVRM Phase III Advanced ovarian cancer 1L 1,256 Non tBRCAm (tumour BRCA) patients Primary endpoint: • FPCD: Q1 2019 DuO-O • Arm 1: bev
Slide 19: Oncology: Lynparza other combinations
Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development Other combinations Trial Population Patients Design Endpoints Status CVRM Phase III Advanced ovarian cancer 1L 806 • Arm 1: Lynparza maintenance therapy for two years or until Primary endpoint: • FPCD: Q2
Slide 20: Oncology: Enhertu breast cancer
Approved medicines Oncology Late-stage development Enhertu (trastuzumab deruxtecan, HER2 ADC) Early development Breast cancer Trial Population Patients Design Endpoints Status CVRM Phase II HER2-positive, unresectable and/or 230 Randomised, open label, sequential assignment Primary endpoint ORR • FP
Slide 21: Oncology: Enhertu gastric cancer
Approved medicines Oncology Late-stage development Enhertu (trastuzumab deruxtecan, HER2 ADC) Early development Gastric cancer Trial Population Patients Design Endpoints Status CVRM Phase II HER2-overexpressing advanced gastric 220 Randomised open label parallel assignment Primary end point ORR • FP
Slide 22: Oncology: Enhertu other cancers
Approved medicines Oncology Late-stage development Enhertu (trastuzumab deruxtecan, HER2 ADC) Early development Other cancers Trial Population Patients Design Endpoints Status CVRM Phase II HER2 expressing tumours 280 Non randomised single group assignment Primary endpoint: ORR • FPCD Q4 2020 DPT02
Slide 23: Oncology: Calquence blood cancers
Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development Blood cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase III Previously untreated CLL 535 • Arm A: chlorambucil + obinutuzumab • Primary endpoint: PFS (Arm A vs. Arm B) • FPCD: Q2 2015
Slide 24: Oncology: Calquence blood cancers
Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development Blood cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase I/II B-cell malignancies 40 Dose escalation and expansion trial of the combination of • Safety • FPCD: Q1 2015 ACE-LY-001 Calque
Slide 25: Oncology: Calquence blood and other cancers
Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development Blood and other cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase I Japanese adults with 34 • Calquence monotherapy • Safety • FPCD: Q2 2017 advanced B-cell malignancies • Dose confirm
Slide 26: Oncology: Koselugo
Approved medicines Oncology Late-stage development Koselugo (selumetinib, MEK inhibitor) Early development Paediatric neurofibromatosis type 1, solid tumours Trial Population Patients Design Endpoints Status CVRM Phase II Paediatric NF1 50 (stratum 1) • Single arm: Koselugo 25mg/m2 BID with 2 strata
Slide 27: Oncology: Lumoxiti
Approved medicines Oncology Late-stage development Lumoxiti (moxetumomab pasudotox,CD22 mAb) Early development Blood cancer Trial Population Patients Design Endpoints Status CVRM Phase III Adults with relapsed or 80 • Multicentre, single-arm, open-label Phase III trial • Primary endpoint: rate of du
Slide 28: Oncology: Savolitinib
Approved medicines Oncology Late-stage development Savolitinib (MET inhibitor) Early development NSCLC and other cancers Trial Population Patients Design Endpoints Status CVRM Phase I Advanced NSCLC 85 • Dose escalation trial • Primary endpoint: safety and tolerability • FPCD: Q2 2013 (all comers) •
Slide 29: Oncology: Capivasertib
Approved medicines Oncology Late-stage development Capivasertib (AKT inhibitor) Early development Breast cancer, prostate cancer Trial Population Patients Design Endpoints Status CVRM Phase III Locally advanced or 800 Double-blind randomised comparative trial • PFS • FPCD Q3 2019 CAPItello-290 metas
Slide 30: Oncology: Monalizumab
Approved medicines Oncology Late-stage development Monalizumab (NKG2a mAb) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I/II Advanced solid tumours 381 Escalation phase Primary endpoints: • FPCD: Q2 2016 • monalizumab + Imfinzi i.v. • Safety • Data anticipate
Slide 31: Oncology - early-stage development
Oncology - early-stage development
Slide 32: Oncology: Imfinzi cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development Cancer Trial Compound Population Patients Design Endpoints Status CVRM Phase I/II Imfinzi Solid tumours 1,022 • Dose escalation: 5 cohorts at Q2W and 1 cohort at Q3W • Safety • FPCD: Q3 2012 STUDY 1108 • Dose ex
Slide 33: Oncology: Imfinzi cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development Cancer Trial Compound Population Patients Design Endpoints Status CVRM Phase Ib/II Imfinzi 1L metastatic MSS- 112 • Part 1 S1 FOLFOX + bevacizumab + Imfinzi + oleclumab Primary • FPCD: Q3 2019 COLUMBIA 1 CRC • P
Slide 34: Oncology: Imfinzi + tremelimumab cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) + Early development tremelimumab (CTLA-4 mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase Ib/II Hepatocellular carcinoma 545 • Arm A: Imfinzi + tremelimumab • Primary endpoints: Safety & tolerability, • FP
Slide 35: Oncology: Imfinzi + MEDI0457 HNSCC
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) + Early development MEDI0457 (DNA HPV Vaccine) Head and neck squamous cell carcinoma (HNSCC) CVRM Trial Population Patients Design Endpoints Status Phase Ib/IIa HPV associated 50 Multi-centre, open label trial to evaluate the saf
Slide 36: Oncology: Datopotamab deruxtecan
Approved medicines Oncology Late-stage development Datopotamab deruxtecan, DS-1062 (TROP2 ADC) Early development NSCLC Trial Population Patients Design Endpoints Status CVRM Phase I NSCLC 350 Open label, two-part (dose escalation, dose expansion) • Primary endpoint: safety • FPCD: Q1 2018 TNBC • Dat
Slide 37: Oncology: AZD0466
Approved medicines Oncology Late-stage development AZD0466 (Bcl2/xL inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced hematologic 102 Monotherapy dose escalation, consisting of two arms: • Primary: safety • FPCD: Q4 2019 malignancies or solid
Slide 38: Oncology: MEDI1191
Approved medicines Oncology Late-stage development MEDI1191 (IL12 modRNA) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced solid tumours 87 First-time-in-human Phase I, open-label, dose-escalation and • Primary endpoint: safety and tolerability • FPCD:
Slide 39: Oncology: AZD1390
Approved medicines Oncology Late-stage development AZD1390 (ATM inhibitor) Early development Cancer Trial Population Subjects Design Endpoints Status CVRM Phase I Recurrent glioblastoma 132 • Primary: investigate the safety, • FPCD Q2 2018 eligible for re-irradiation, brain • Designed to evaluate th
Slide 40: Oncology: Adavosertib
Approved medicines Oncology Late-stage development Adavosertib (AZD1775, WEE-1 inhibitor) Early development Ovarian cancer, uterine serous cancer, solid tumours Trial Population Patients Design Endpoints Status CVRM Phase II Platinum-resistant (PR) 95 • Arm B: paclitaxel + adavosertib • Primary endp
Slide 41: Oncology: MEDI2228
Approved medicines Oncology Late-stage development MEDI2228 (BCMA antibody drug conjugate) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/refractory multiple 142 First-time-in-human Phase I, multi-centre, open-label, single-arm, Primary endpoints: •
Slide 42: Oncology: AZD2811NP
Approved medicines Oncology Late-stage development AZD2811NP (AURN) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 72 • Arm 1: AZD2811NP dose escalation • Safety and tolerability • FPCD: Q4 2015 • Arm 2: AZD2811NP dose expansion SCLC • PK and ef
Slide 43: Oncology: AZD4573
Approved medicines Oncology Late-stage development AZD4573 (CDK9 inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/refractory 45 Arm 1: dose escalation in haematological malignancies excluding Primary: • FPCD: Q4 2017 haematologic malignancie
Slide 44: Oncology: AZD4635
Approved medicines Oncology Late-stage development AZD4635 (A2AR inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Phase Ia: patients with 313 Phase Ia – solid tumours or mCPRC: Primary outcome measure: • FPCD: Q2 2016 advanced solid tumours • AZD4635
Slide 45: Oncology: AZD5153
Approved medicines Oncology Late-stage development AZD5153 (BRD4 inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I/Ib Relapsed/refractory solid 60 Monotherapy dose escalation in advanced solid tumours and • Primary: safety • FPCD: Q2 2017 tumours, lym
Slide 46: Oncology: MEDI5395
Approved medicines Oncology Late-stage development MEDI5395 (rNDV GMCSF) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Select advanced solid 164 First-time-in-human Phase I, open-label, dose-escalation and • Primary endpoint: safety and tolerability • FPCD:
Slide 47: Oncology: MEDI5752
Approved medicines Oncology Late-stage development MEDI5752 (PD-1/CTLA-4 bispecific mAb) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I/IIa Advanced solid tumours 188 Open-label, dose-escalation and dose-expansion: Primary endpoints: • FPCD: Q2 2018 • dose-es
Slide 48: Oncology: AZD5991
Approved medicines Oncology Late-stage development AZD5991 (MCL1 inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I/Ib/IIa Relapsed/refractory 177 • Arm1: monotherapy dose escalation & expansions in • Primary: safety • FPCD: Q3 2017 haematologic malign
Slide 49: Oncology: Ceralasertib
Approved medicines Oncology Late-stage development Ceralasertib (AZD6738, ATR inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 250 • Arm 1: ceralasertib + carboplatin • Safety and tolerability • FPCD: Q4 2014 • Arm 2: ceralasertib dose
Slide 50: Oncology: AZD7648
Approved medicines Oncology Late-stage development AZD7648 (selective DNA-PK inhibitor) Early development Advanced solid tumours Trial Population Patients Design Endpoints Status CVRM Phase I Advanced malignancies 234 • First in human modular dose escalation and dose expansion • Primary outcome meas
Slide 51: Oncology: AZD8701
Approved medicines Oncology Late-stage development AZD8701 (FOXP3 antisense oligonucleotide) Early development Solid tumours CVRM Trial Population Patients Design Endpoints Status Phase I/Ib Advanced solid tumours 123 Dose escalation and dose expansion trial Primary endpoints: • FPCD: Q3 2020 NCT045
Slide 52: Oncology: Oleclumab
Approved medicines Oncology Late-stage development Oleclumab (MEDI9447, CD73 mAb) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced malignancies 348 Dose escalation phase Primary endpoints: • FPCD: Q3 2015 • oleclumab i.v. • Safety • Data anticipated: 2
Slide 53: Oncology: AZD9496
Approved medicines Oncology Late-stage development AZD9496 (SERD, oral) Early development Breast cancer Trial Population Patients Design Endpoints Status CVRM Phase I ER+ breast cancer c. 50 • This is an open label randomised multicentre pre-surgical • Primary outcome measures: PD changes • FPCD: Q4
Slide 54: Oncology: AZD9833
Approved medicines Oncology Late-stage development AZD9833 (SERD, oral) Early development Breast cancer Trial Population Patients Design Endpoints Status CVRM Phase I ER+ breast cancer 240 • Open label multicentre trial of AZD9833 administered orally in • Primary outcome measures: safety and • FPCD:
Slide 55: Oncology: IPH5201
Approved medicines Oncology Late-stage development IPH5201 (CD39 mAb) Early development Solid tumours Trial Population Patients Design Endpoints Status CVRM Phase I Advanced Solid tumours 204 • First time in human Phase I, open-label, dose- Primary endpoints: • FPCD: Q1 2020 escalation trial to dete
Slide 56: BioPharmaceuticals - approved medicines and late-stage pipeline
BioPharmaceuticals - approved medicines and late-stage pipeline
Slide 57: Farxiga heart failure and chronic kidney disease
Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development Heart failure and chronic kidney disease Trial Population Patients Design Endpoints Status CVRM Phase III CHF patients with HFrEF 4,744 • Arm 1: Farxiga 10mg or 5 mg QD + SoC therapy • Primary endpoint: ti
Slide 58: Brilinta cardiovascular risk reduction
Approved medicines Oncology Late-stage development Brilinta (P2Y12 receptor antagonist) Early development Cardiovascular risk reduction Trial Population Patients Design Endpoints (primary) Status CVRM Phase III Patients with type-2 diabetes 19,000 • Arm 1: Brilinta 60mg BiD • Primary endpoint: compo
Slide 59: Lokelma hyperkalaemia
Approved medicines Oncology Late-stage development Lokelma (sodium zirconium cyclosilicate) Early development Hyperkalaemia Trial Population Patients Design Endpoints Status CVRM Phase II Patients with chronic heart 182 • Arm 1: Lokelma 5g QD for 12 weeks. Option to uptitrate to 10 • Primary endpoin
Slide 60: Roxadustat anaemia
Approved medicines Oncology Late-stage development Roxadustat (HIF-PH inhibitor) Early development Anaemia Trial Population Patients Design Endpoints Status CVRM Phase III Anaemia in CKD in patients 922 • Arm 1: roxadustat • Primary endpoint: Haemoglobin response • FPCD: Q4 2012 ANDES not receiving
Slide 61: Roxadustat anaemia
Approved medicines Oncology Late-stage development Roxadustat (HIF-PH inhibitor) Early development Anaemia Trial Population Patients Design Endpoints Status CVRM Phase III Anaemia in newly initiated 1,043 • Arm 1: roxadustat • Primary endpoint: Haemoglobin response • FPCD: Q4 2013 HIMALAYAS dialysis
Slide 62: Eklira/Tudorza COPD
Approved medicines Oncology Late-stage development Eklira/Tudorza (LAMA, DPI) Early development COPD Trial Population Number of patients Design Endpoints Status CVRM Phase I Healthy Chinese 18 Open-label, 2-period ascending dose incomplete block, cross-over • To investigate the PK of aclidinium • In
Slide 63: Duaklir Genuair COPD
Approved medicines Oncology Late-stage development Duaklir Genuair (LAMA/LABA, DPI) Early development COPD Trial Population Patients Design Endpoints Status CVRM Phase III Patients with stable COPD 1,060 • Arm 1: Duaklir Genuair 400/12 μg DPI Primary endpoints: • FPCD: Q1 2017 AVANT • Arm 2: aclidin
Slide 64: Breztri, Trixeo COPD
Approved medicines Oncology Late-stage development Breztri, Trixeo (PT010, LAMA/LABA/ICS, pMDI) Early development COPD Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to very severe 500 Treatments (52-week treatment period) Primary endpoints: • FPCD: Q3 2015 COPD • BGF (bud
Slide 65: Daliresp/Daxas COPD
Approved medicines Oncology Late-stage development Daliresp/Daxas (PDE4 inhibitor, oral) Early development COPD Trial Population Patients Design Endpoints Status CVRM Post Launch COPD 124,080 • This is a retrospective cohort trial comparing COPD patients • Primary endpoint: all-cause mortality (up •
Slide 66: Fasenra severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Fasenra (IL5R mAb) Early development Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III A multi-centre, open-label, 447 • Arm 1: Fasenra 30mg Q4W s.c. • Primary endpoint: safety and tolerability • FPCD: Q2 2
Slide 67: Fasenra severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Fasenra (IL5R mAb) Early development Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe asthma, inadequately 2,133 • Arm 1: Fasenra 30mg Q4W s.c. • Primary endpoint: safety and tolerability • FPCD: Q4
Slide 68: Fasenra severe asthma, COPD
Approved medicines Oncology Late-stage development Fasenra (IL5R mAb) Early development Severe, uncontrolled asthma, COPD Trial Population Patients Design Endpoints Status CVRM Phase III Severe asthma on ICS-LABA 121 Open label Fasenra 30mg Q4w • Primary endpoint: percentage of patients/ • FPCD: Q4
Slide 69: Fasenra nasal polyposis and eosinophilic diseases
Approved medicines Oncology Late-stage development Fasenra (IL5R mAb) Early development Nasal polyposis and other eosinophilic diseases Trial Population Patients Design Endpoints Status CVRM Phase III Patients with severe bilateral 413 • Arm 1: Fasenra 30mg Q8W s.c. • Primary endpoint: effect of Fas
Slide 70: Fasenra dermatology
Approved medicines Oncology Late-stage development Fasenra (IL5R mAb) Early development Dermatology Trial Population Patients Design Endpoints Status CVRM Phase III Patients with symptomatic 120 • Arm 1: Fasenra regimen • Primary endpoint: • Initiating FJORD (newly diagnosed or relapsing) • Arm 2: p
Slide 71: Tezepelumab severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Tezepelumab (TSLP mAb) Early development Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe asthma 1,061 • Arm 1: tezepelumab s.c. • Primary endpoint: Annual asthma • FPCD: Q1 2018 NAVIGATOR Age 12-80
Slide 72: Tezepelumab asthma and COPD
Approved medicines Oncology Late-stage development Tezepelumab (TSLP mAb) Early development Severe, uncontrolled asthma & COPD Trial Population Patients Design Endpoints Status CVRM Phase II Severe asthma 116 • Arm 1: tezepelumab s.c. • Primary endpoint: number of airway • FPCD: Q4 2018 CASCADE Age
Slide 73: PT027 asthma
Approved medicines Oncology Late-stage development PT027 (SABA/ICS, pMDI) Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to severe asthma 3,100 Treatments (minimum 24-week treatment period) Primary endpoint: • FPCD: Q4 2018 MANDALA • BDA (budesonid
Slide 74: Anifrolumab lupus
Approved medicines Oncology Late-stage development Anifrolumab (type I interferon receptor mAb) Early development Lupus (SLE / LN) Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to severe SLE 450 • Arm 1: 300mg i.v. anifrolumab Q4W for 48 weeks • Primary endpoint: response
Slide 75: Brazikumab inflammatory bowel disease
Approved medicines Oncology Late-stage development Brazikumab (IL-23 inhibitor) Early development Inflammatory Bowel Disease (Crohn’s Disease, Ulcerative Colitis) Trial Population Patients Design Endpoints Status CVRM Phase IIb / III Crohn’s Disease 1,140 • Arm 1: brazikumab 1440 mg IV induction + 2
Slide 76: Nirsevimab RSV infection
Approved medicines Oncology Late-stage development Nirsevimab (MEDI8897, Respiratory syncytial virus mAb-YTE ) Early development Infection Trial Population Patients Design Endpoints Status CVRM Phase IIb 29-35 WK GA (Gestational 1,453 • Randomised, double-blind, placebo-controlled trial • Safety and
Slide 77: AZD1222 prevention of COVID-19
Approved medicines Oncology Late-stage development AZD1222 (SARS-CoV-2) Early development Prevention of COVID-19 Trial Population Patients Design Endpoints Status CVRM Phase I/II Healthy adults 1,077 Single-blinded, randomised, controlled, multi-centre trial • Primary endpoint: efficacy and safety •
Slide 78: AZD7442 prevention and treatment of COVID-19
Approved medicines Oncology Late-stage development AZD7442 (LAAB combination of AZD8895 & AZD1061) Early development Prevention and treatment of COVID-19 Trial Population Patients/Subjects Design Endpoints Status CVRM Phase I Healthy adults 60 Double-blinded, randomised, placebo controlled, single a
Slide 79: COVID-19 trials: treatment of COVID-19
Approved medicines Oncology Late-stage development COVID-19 trials Early development Treatment of COVID-19 Trial Compound Population Patients Design Endpoints Status CVRM Phase IIb Calquence COVID-19 61 • Arm 1: Calquence + best supportive care • Primary outcomes: safety, subject alive • FPCD: Q2 20
Slide 80: BioPharmaceuticals - early-stage development
BioPharmaceuticals - early-stage development
Slide 81: Cotadutide diabetes/CKD, NASH
Approved medicines Oncology Late-stage development Cotadutide (MEDI0382, GLP-1-glucagon agonist) Early development Diabetes/CKD, NASH Trial Population Patients Design Endpoints Status CVRM Phase II Adults with type-2 44 • Part A: cotadutide or placebo s.c. • Primary: change in hepatic glycogen conce
Slide 82: Verinurad CKD, HFpEF
Approved medicines Oncology Late-stage development Verinurad (RDEA3170, URAT1 inhibitor) Early development CKD, HFpEF Trial Population Patients Design Endpoints Status CVRM Phase II Patients with: 725 • Arm A; Verinurad 12 mg + allopurinol 300 mg Ratio of urinary albumin to urinary • FPCD: Q3 2019 •
Slide 83: Verinurad HFpEF
Approved medicines Oncology Late-stage development Verinurad (RDEA3170, URAT1 inhibitor) Early development HFpEF Trial Population Patients Design Endpoints Status CVRM Phase II Patients with heart failure with 435 • Arm A: verinurad 12 mg + allopurinol 300 mg Peak V02 Change from baseline at Week •
Slide 84: AZD2373 chronic kidney disease
Approved medicines Oncology Late-stage development AZD2373 Early development Chronic Kidney Disease Trial Population Patients Design Endpoints Status CVRM Phase I Healthy volunteers 48 SAD Primary: • FPCD: Q1 2020 • Safety and tolerability NCT04269031 Dose escalation in 6 cohorts with 6 volunteers r
Slide 85: AZD2693 NASH
Approved medicines Oncology Late-stage development AZD2693 (resolution of NASH) Early development NASH Trial Population Patients Design Endpoints Status CVRM Phase I Healthy volunteers 48 SAD Primary: • FPCD: Q4 2019 • Safety and tolerability • Data anticipated: H1 2021 NCT04142424 6 cohorts with 6
Slide 86: AZD3366 cardiovascular disease
Approved medicines Oncology Late-stage development AZD3366 Early development Cardiovascular Disease Trial Population Patients Design Endpoints Status CVRM Phase I Healthy volunteers 87 SAD Primary: • FPCD: Q4 2020 • Safety and tolerability NCT04588727 Part A Dose escalation in 6 cohorts with 6 volun
Slide 87: MEDI3506 diabetic kidney disease
Approved medicines Oncology Late-stage development MEDI3506 (IL33 ligand mAb) Early development Diabetic Kidney Disease (DKD) Trial Population Patients Design Endpoints Status CVRM Phase II Adult patients with diabetic 168 Randomised, double-blind, placebo-controlled, multicenter trial to • Efficacy
Slide 88: AZD4831 cardiovascular disease
Approved medicines Oncology Late-stage development AZD4831 (MPO inhibitor) Early development Cardiovascular disease Trial Population Patients Design Endpoints Status CVRM Phase I Healthy patients c. 96 SAD trial (one trial site in Germany) • Safety and tolerability • FPCD: Q3 2016 • Planned to inves
Slide 89: AZD5718 cardiovascular disease
Approved medicines Oncology Late-stage development AZD5718 (FLAP inhibitor) Early development Cardiovascular disease Trial Population Patients Design Endpoints Status CVRM Phase IIa CAD 129 • Arm 1: AZD5718 Dose A • Primary endpoint: PD effect of AZD5718 • FPCD: Q4 2017 • Arm 2: AZD5718 Dose B by as
Slide 90: AZD6615 dyslipidemia
Approved medicines Oncology Late-stage development AZD6615 (PCSK9 inhibitor, oral) Early development Dyslipidemia Trial Population Patients Design Endpoints Status CVRM Phase I Healthy volunteers 40 SAD Primary: • FPCD: Q3 2019 • Safety and tolerability NCT04055168 3 cohorts of non-Asian subjects (P
Slide 91: AZD8233 dyslipidemia
Approved medicines Oncology Late-stage development AZD8233 (PCSK9 inhibitor, sub-cutaneious) Early development Dyslipidemia Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 72 SAD Primary: • FPCD: Q3 2018 • Safety and tolerability NCT03593785 7 cohorts with 6 subjects
Slide 92: MEDI8367 chronic kidney disease
Approved medicines Oncology Late-stage development MEDI8367 Early development Chronic Kidney Disease Trial Population Patients Design Endpoints Status CVRM Phase I Healthy volunteers 70 Single ascending dose Primary: • FPCD: Q3 2020 Chronic Kidney Disease 6 cohorts • Safety and tolerability NCT04365
Slide 93: AZD8601 cardiovascular disease
Approved medicines Oncology Late-stage development AZD8601 (VEGF-A modified RNA) Early development Cardiovascular disease Trial Population Patients Design Endpoints Status CVRM Phase I Type 2 diabetic patients c. 60 SAD trial (one trial site in Germany) • Safety and tolerability • FPCD: Q1 2017 • Pl
Slide 94: AZD9977 heart failure
Approved medicines Oncology Late-stage development AZD9977 Early development Heart failure Trial Population Patients Design Endpoints Status CVRM Phase I Healthy volunteers 27 MAD Primary: • FPCD: Q1 2018 Dose escalation in 3 cohorts with 6 subjects receiving AZD9977 • Safety and tolerability • LPCD
Slide 95: Biologics cardiovascular & metabolic diseases
Approved medicines Oncology Late-stage development Biologics Early development Cardiovascular & metabolic diseases Trial Compound Population Patients Design Endpoints Status CVRM Phase IIb MEDI6012 Subjects 30-80 540 • Cohort A: 2-dose regimen Primary endpoints: Infarct size as a percentage of left
Slide 96: AZD0449 asthma
Approved medicines Oncology Late-stage development AZD0449 (inhaled JAK-1 inhibitor) Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects and patients 156 SAD/MAD/Bridge trial (UK) Primary endpoint: • FPCD: Q4 2018 with mild asthma Part 1 SAD • Saf
Slide 97: AZD1402 asthma
Approved medicines Oncology Late-stage development AZD1402 (IL4 receptor antagonist) Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase Ib Patients with mild asthma 84 PoM. Primary endpoint: • FPCD: Q3 2018 A dose-escalating, single blind trial to assess the • Safe
Slide 98: MEDI3506 COPD, atopic dermatitis
Approved medicines Oncology Late-stage development MEDI3506 (IL33 ligand mAb) Early development COPD, atopic dermatitis Trial Population Patients Design Endpoints Status CVRM Phase I (Combined SAD / SAD: healthy subjects with SAD: 56 SAD: • Safety and tolerability • FPCD: Q2 2017 MAD) mild atopy • 7
Slide 99: AZD7986 COPD
Approved medicines Oncology Late-stage development AZD7986 (DPP1) Early development COPD Trial Population Patients Design Endpoints Status CVRM Phase I Healthy volunteers 15 This is a phase I, non-randomised, fixed sequence, 3-period, • Safety and tolerability • FPCD: Q1 2016 drug-drug interaction t
Slide 100: AZD8154 asthma
Approved medicines Oncology AZD8154 (PI3Kgδ inhibitor) Late-stage development Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 78 SAD/MAD Primary endpoint: • FPCD: Q3 2018 A Phase I trial to assess the safety, tolerability and PK of • Safety an
Slide 101: AZD8871 respiratory
Approved medicines Oncology Late-stage development AZD8871 (MABA, inhaled) Early development Respiratory Trial Population Patients Design Endpoints Status CVRM Phase IIa Patients with COPD 73 Randomised, double-blind, placebo and active-controlled Primary endpoint: • FPCD: Q4 2018 crossover trial. E
Slide 102: AZD9567 respiratory
Approved medicines Oncology Late-stage development AZD9567 (SGRM, oral) Early development Respiratory Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 71 MAD trial with a total of 6 dose levels of AZD9567: 10 mg, 20mg, Primary endpoint: • FPCD: Q2 2016 40mg, 80mg and 1
Slide 103: AZD0284 plaque psoriasis
Approved medicines Oncology Late-stage development AZD0284 (RORγ inverse agonist) Early development Plaque psoriasis vulgaris Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 80 Part 1 (SAD) • Safety and tolerability and PK following • FPCD: Q3 2016 • Seven different d
Slide 104: MEDI0618 osteoarthritis pain
Approved medicines Oncology Late-stage development MEDI0618 (PAR2 antagonist mAb) Early development Osteoarthritis pain Trial Population Patients Design Endpoints Status CVRM Phase I Painful osteoarthritis of the knee 64 (healthy • SAD • Safety, tolerability and PK • FPCD: Q4 2019 volunteers) • Up t
Slide 105: MEDI1341 Parkinson's disease
Approved medicines Oncology Late-stage development MEDI1341 (alpha-synuclein mAb) Early development Parkinson’s Disease Trial Population Patients Design Endpoints Status CVRM Phase I Healthy volunteers 48 • SAD • Safety, tolerability, PK, PD • FPCD: Q4 2017 • Up to 6 i.v. cohorts are planned vs. pla
Slide 106: AZD4041 opioid use disorder
Approved medicines Oncology Late-stage development AZD4041 (orexin 1 receptor antagonist) Early development Opioid use disorder Trial Population Patients Design Endpoints Status CVRM Phase I Healthy volunteers 48 healthy • Randomised, double blind, single ascending dose • Safety, tolerability, PK, P
Slide 107: AZD5634 cystic fibrosis
Approved medicines Oncology Late-stage development AZD5634 (ENaC, inhaled) Early development Cystic Fibrosis Trial Population Patients Design Endpoints Status CVRM Phase I Healthy volunteers 56 A randomised, single-blind, placebo-controlled trial to assess the • Safety and tolerability • FPCD: Q1 20
Slide 108: MEDI7352 osteoarthritis pain
Approved medicines Oncology Late-stage development MEDI7352 (NGF TNF bispecific mAb) Early development Osteoarthritis pain Trial Population Patients Design Endpoints Status CVRM Phase I Painful osteoarthritis of the knee 160 • SAD & MAD • Safety, tolerability, PK, PD • FPCD: Q1 2016 • Up to 12 i.v.
Slide 109: Other biologics: infections
Approved medicines Oncology Late-stage development Other biologics Early development Infections Trial Compound Population Patients Design Endpoints Status CVRM Phase II Anti-Staph AT Intubated ICU 213 • Placebo-controlled, single-dose, dose-ranging • Efficacy and safety • FPCD: Q4 2014 (suvratoxumab
Slide 110: List of abbreviations
List of abbreviations 14C Radioactive isotope of carbon, Carbon 14 CHF Chronic heart failure FLAP 5-lipoxygenase-activating protein 1L, 2L, 3L 1st, 2nd or 3rd line CKD Chronic kidney disease FPDC First patient commenced dosing 5-FU 5-fluorouracil CLL Chronic lymphocytic leukaemia FPG Fasting plasma
Slide 111: List of abbreviations
List of abbreviations LABA Long acting beta agonist PASI Psoriasis area severity index SAE Serious adverse event LAMA Long acting muscarinic agonist PBD Pyrrolobenzodiazepine SBRT Stereotactic body radiation therapy LCAT Lecithin-cholesterol acyltransferase pCR Pathological complete response s.c. Su
Slide 112: Clinical trials appendix: Year-to-date and Q3 2020 results update
Clinical trials appendix Year-to-date and Q3 2020 results update