Slide 1: Clinical trials appendix: Full year and Q4 2020 results update
Clinical trials appendix Full year and Q4 2020 results update
Slide 2: Movement since Q3 2020 update
Movement since Q3 2020 update New to Phase I New to Phase II New to Pivotal trial New to registration NME NME NME NME AZD3366 AZD8233 AZD7442 COVID-19 Vaccine AstraZeneca [EU] 1 CD39L3 CV disease hypercholesterolemia CV disease COVID-19 long-acting antibody combination SARS-CoV-2 COVID vaccine preve
Slide 3: Movement since Q3 2020 update
Movement since Q3 2020 update Removed from Phase I Removed from Phase II Removed from Phase III Removed from registration NME NME Additional indication NME AZD5153 abediterol# Imfinzi# + tremelimumab KESTREL COVID-19 Vaccine AstraZeneca# [EU] 1 BRD4 inhibitor solid tumours, haematological LABA asthm
Slide 4: Q4 2020 new molecular entity (NME) pipeline
Q4 2020 new molecular entity (NME)1 pipeline Phase I Phase II Phase III Under Review 21 New Molecular Entities 21 New Molecular Entities 10 New Molecular Entities 0 New Molecular Entities AZD0466 adavosertib# capivasertib# + abiraterone CAPItello-281 Imfinzi#+tremelimumab Imfinzi#+monalizumab# BCL2/
Slide 5: Q4 2020 new molecular entity (NME) pipeline
Q4 2020 new molecular entity (NME)1 pipeline Phase I Phase II Phase III 14 New Molecular Entities 21 New Molecular Entities 5 New Molecular Entities AZD4041# AZD7442 AZD0284 anifrolumab# MEDI3506 orexin 1 receptor antagonist opioid use long-acting antibody combination RORg psoriasis / respiratory Ty
Slide 6: Q4 2020 lifecycle management (LCM) pipeline
Q4 2020 lifecycle management (LCM)1 pipeline Phase I Phase II Phase III Under Review 1 Project 8 Projects 30 Projects 0 Projects Imfinzi#+azacitidine# Enhertu# DESTINY-CRC-01 Calquence# Imfinzi# CALLA Imfinzi#+CTx TOPAZ-1 PD-L1+azacitidine MDS ADC colorectal cancer BTK inhibitor 1st line MCL PD-L1 a
Slide 7: Q4 2020 lifecycle management (LCM) pipeline
Q4 2020 lifecycle management (LCM)1 pipeline Phase I Phase II Phase III Under Review 0 Projects 3 Projects 9 Projects 1 Project Fasenra ARROYO Breztri Farxiga/Forxiga DAPA-CKD IL-5R chronic spontaneous urticaria LABA/LAMA/ICS asthma SGLT2 CKD Farxiga/Forxiga DAPA-MI Fasenra HILLIER SGLT2 prevention
Slide 8: Estimated key regulatory submission acceptances
Estimated key regulatory submission acceptances brazikumab crohns disease capivasertib + fulvestrant locally advanced or Fasenra mBC CAPItello-291 severe asthma (China) capivasertb + CTx 1L mTNBC nirsevimab PT027 asthma CAPItello-290 passive RSV immunisation NME Imfinzi + tremelimumab HCC Imfinzi +
Slide 9: Designations
Designations 5 17 12 36 29 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 10: Oncology – approved medicines and late-stage pipeline
Oncology – approved medicines and late-stage pipeline
Slide 11: Oncology: Tagrisso
Approved medicines Oncology Tagrisso (highly-selective, irreversible EGFRi) Late-stage development 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 12: Oncology: Tagrisso
Approved medicines Oncology Tagrisso (highly-selective, irreversible EGFRi) Late-stage development 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 13: Oncology: Imfinzi
Approved medicines Oncology Imfinzi (PD-L1 mAb) Late-stage development Early development NSCLC, early disease Trial Population Patients Design Endpoints Status CVRM Phase III Completely resected 332 • Arm 1: Imfinzi + SoC chemo Primary endpoint: • FPCD: Q3 2020 MERMAID-1 Stage II and III NSCLC • Arm
Slide 14: Oncology: Imfinzi +/- treme
Approved medicines Oncology Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Late-stage development 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 15: Oncology: Imfinzi
Approved medicines Oncology Imfinzi (PD-L1 mAb) Late-stage development 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 16: Oncology: Imfinzi +/- treme
Approved medicines Oncology Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Late-stage development 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 17: Oncology: Imfinzi +/- treme
Approved medicines Oncology Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Late-stage development 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 18: Oncology: Lynparza
Approved medicines Oncology Lynparza (PARP inhibitor) Late-stage development Early development Multiple 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 20
Slide 19: Oncology: Lynparza
Approved medicines Oncology Lynparza (PARP inhibitor) Late-stage development 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 20: Oncology: Lynparza
Approved medicines Oncology Lynparza (PARP inhibitor) Late-stage development 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 21: Oncology: Enhertu
Approved medicines Oncology Enhertu (trastuzumab deruxtecan, HER2 ADC) Late-stage development 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 22: Oncology: Enhertu
Approved medicines Oncology Enhertu (trastuzumab deruxtecan, HER2 ADC) Late-stage development Early development Gastric cancer Trial Population Patients Design Endpoints Status CVRM Phase II HER2-overexpressing advanced gastric 233 Randomised open label parallel assignment Primary end point ORR • FP
Slide 23: Oncology: Enhertu
Approved medicines Oncology Enhertu (trastuzumab deruxtecan, HER2 ADC) Late-stage development Early development Other cancers Trial Population Patients Design Endpoints Status CVRM Phase II HER2-over-expressing or mutated, 170 Non randomised parallel group assignment Primary endpoint ORR • FPCD Q2 2
Slide 24: Oncology: Enhertu
Approved medicines Oncology Enhertu (trastuzumab deruxtecan, HER2 ADC) Late-stage development 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 25: Oncology: Calquence
Approved medicines Oncology Calquence (BTK inhibitor) Late-stage development 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 26: Oncology: Calquence
Approved medicines Oncology Calquence (BTK inhibitor) Late-stage development 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 27: Oncology: Calquence
Approved medicines Oncology Calquence (BTK inhibitor) Late-stage development 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 28: Oncology: Koselugo
Approved medicines Oncology Koselugo (selumetinib, MEK inhibitor) Late-stage development 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 29: Oncology: Lumoxiti
Approved medicines Oncology Lumoxiti (moxetumomab pasudotox,CD22 mAb) Late-stage development 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 30: 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 31: 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 32: Oncology: Monalizumab
Approved medicines Oncology Late-stage development Monalizumab (NKG2a mAb) Early development Cancers Trial Population Patients Design Endpoints Status CVRM Phase III Recurrent or Metastatic 600 • Arm A: monalizumab + cetuximab i.v. • Primary: OS • FPCD: Q4 2020 INTERLINK-1 SCCHN, 2L • Arm B: placebo
Slide 33: Oncology: Camizestrant
Approved medicines Oncology Late-stage development Camizestrant (AZD9833, oral SERD) Early development Breast cancer Trial Population Patients Design Endpoints Status CVRM Phase III ER+ HER2- breast cancer 1,342 A randomised, multicentre, double-blind, Phase III trial of • Primary endpoint: PFS • FP
Slide 34: Oncology: Datopotamab deruxtecan
Approved medicines Oncology Late-stage development Datopotamab deruxtecan (TROP2 ADC) Early development NSCLC Trial Population Patients Design Endpoints Status CVRM Phase III NSCLC (without actionable 590 Randomised, open label • Primary endpoints: PFS, OS • FPCD: Q4 2020 TROPION-Lung01 mutation) •
Slide 35: Oncology – early-stage development
Oncology – early-stage development
Slide 36: Oncology: Imfinzi
Approved medicines Oncology Imfinzi (PD-L1 mAb) Late-stage development 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 37: Oncology: Imfinzi
Approved medicines Oncology Imfinzi (PD-L1 mAb) Late-stage development 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 38: Oncology: Imfinzi + tremelimumab
Approved medicines Oncology Imfinzi (PD-L1 mAb) + Late-stage development 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 39: Oncology: Imfinzi + MEDI0457
Approved medicines Oncology Imfinzi (PD-L1 mAb) + Late-stage development 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 40: 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 41: 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 42: 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 43: Oncology: Adavosertib
Approved medicines Oncology Late-stage development Adavosertib (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 endpoint: ORR
Slide 44: 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 45: 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 46: 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 47: 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 48: 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 49: Oncology: AZD5305
Approved medicines Oncology Late-stage development AZD5305 (PARP inhibitor) Early development Solid tumours Trial Population Patients Design Endpoints Status CVRM Phase I Advanced, metastatic HER2 612 A modular phase I/IIa, open-label, multicentre trial to assess the • Primary endpoint: safety/toler
Slide 50: 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 188 First-time-in-human Phase I, open-label, dose-escalation and • Primary endpoint: safety and tolerability • FPCD:
Slide 51: 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 261 Open-label, dose-escalation and dose-expansion: Primary endpoints: • FPCD: Q2 2018 • dose-es
Slide 52: 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 121 • Arm1: monotherapy dose escalation & expansions in • Primary: safety • FPCD: Q3 2017 haematologic malign
Slide 53: 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 54: 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 55: 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 56: Oncology: MEDI9253
Approved medicines Oncology Late-stage development MEDI9253 (rNDV-IL12) Early development Solid tumours Trial Population Patients Design Endpoints Status CVRM Phase I Advanced solid tumours 86 First-time-in-human Phase I, open-label, dose-escalation and • Primary endpoint: safety and tolerability •
Slide 57: Oncology: Oleclumab
Approved medicines Oncology Late-stage development Oleclumab (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: H1 2021 NCT
Slide 58: 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 59: BioPharmaceuticals – approved medicines and late-stage pipeline
BioPharmaceuticals – approved medicines and late-stage pipeline
Slide 60: Farxiga
Approved medicines Oncology Farxiga (SGLT2 inhibitor) Late-stage development 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 61: Brilinta
Approved medicines Oncology Brilinta (P2Y12 receptor antagonist) Late-stage development 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 62: Lokelma
Approved medicines Oncology Lokelma (sodium zirconium cyclosilicate) Late-stage development 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 63: Roxadustat
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 64: Roxadustat
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 65: Eklira/Tudorza
Approved medicines Oncology Eklira/Tudorza (LAMA, DPI) Late-stage development Early development COPD Trial Population Number of patients Design Endpoints Status CVRM Phase I Healthy Chinese 20 Open-label, 2-period ascending dose incomplete block, cross-over • To investigate the PK of aclidinium • In
Slide 66: Duaklir Genuair
Approved medicines Oncology Duaklir Genuair (LAMA/LABA, DPI) Late-stage development 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 67: Breztri, Trixeo
Approved medicines Oncology Breztri, Trixeo (PT010, LAMA/LABA/ICS, pMDI) Late-stage development Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe asthma 2,800 Treatments (24 to 52 week variable length) • Primary endpoint: Change from baseline • FPCD: Q1
Slide 68: Daliresp/Daxas
Approved medicines Oncology Daliresp/Daxas (PDE4 inhibitor, oral) Late-stage development 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 69: Fasenra: severe, uncontrolled asthma
Approved medicines Oncology Fasenra (IL5R mAb) Late-stage development 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 70: Fasenra: severe, uncontrolled asthma
Approved medicines Oncology Fasenra (IL5R mAb) Late-stage development 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 71: Fasenra: asthma, COPD
Approved medicines Oncology Fasenra (IL5R mAb) Late-stage development 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 72: Fasenra: nasal polyposis and eosinophilic diseases
Approved medicines Oncology Fasenra (IL5R mAb) Late-stage development 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 73: Fasenra: dermatology
Approved medicines Oncology Fasenra (IL5R mAb) Late-stage development 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 74: Tezepelumab: severe 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 75: Tezepelumab: asthma and COPD
Approved medicines Oncology Late-stage development Tezepelumab (TSLP mAb) Early development Severe, uncontrolled asthma & COPD CVRM Trial Population Patients Design Endpoints Status Phase II Severe asthma 116 • Arm 1: tezepelumab s.c. • Primary endpoint: number of airway • FPCD: Q4 2018 CASCADE Age
Slide 76: PT027
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 77: Anifrolumab
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 78: Brazikumab
Approved medicines Oncology Late-stage development Brazikumab (IL23 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 high IV dose on day 1, 29
Slide 79: Nirsevimab
Approved medicines Oncology Late-stage development Nirsevimab (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 efficacy
Slide 80: AZD1222 (SARS-CoV-2)
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 81: AZD7442
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 82: COVID-19 trials
Approved medicines Oncology Late-stage development COVID-19 trials Early development Treatment of COVID-19 Trial Compound Population Patients Design Endpoints Status CVRM Phase III Farxiga COVID-19 1,250 • Current SoC or current SoC + Farxiga • Primary outcome measures: time to first • FPCD: Q2 2020
Slide 83: BioPharmaceuticals – early-stage development
BioPharmaceuticals – early-stage development
Slide 84: Cotadutide
Approved medicines Oncology Late-stage development Cotadutide (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 concentration p
Slide 85: Verinurad
Approved medicines Oncology Late-stage development Verinurad (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 • sUA ≥6.0
Slide 86: AZD2373
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 87: AZD2693
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: H2 2021 NCT04142424 6 cohorts with 6
Slide 88: AZD3427
Approved medicines Oncology Late-stage development AZD3427 (relaxin) Early development Heart failure Trial Population Patients Design Endpoints Status CVRM Phase I SAD – Healthy Volunteers 96 • Multi-center single and multiple ascending dose study (SAD Safety & Tolerability • FPCD: Q4 2020 MAD – Hea
Slide 89: AZD3366
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 90: MEDI3506: diabetic kidney disease
Approved medicines Oncology Late-stage development MEDI3506 (IL33 ligand mAb) Early development Diabetic kidney disease Trial Population Patients Design Endpoints Status CVRM Phase II Adult patients with diabetic 565 • Arm A- MEDI3506 Dose 1 + dapagliflozin • Efficacy and safety • FPCD: Q4 2019 kidn
Slide 91: AZD4831
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 92: AZD5718
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 93: AZD8233
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 • LPCD: Q3 2019 NCT03593785 7 cohorts
Slide 94: MEDI8367
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 CKD 6 cohorts • Safety and tolerability NCT04365218 Arm 1: MEDI8367
Slide 95: AZD8601
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 96: AZD9977
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 97: Zibotentan
Approved medicines Oncology Late-stage development Zibotentan (endothelin receptor antagonist) Early development Chronic kidney disease Trial Population Patients Design Endpoints Status CVRM Phase IIb Chronic Kidney Disease 660 Global recruitment Primary Endpoint: • Initiating Change in log-transfor
Slide 98: Biologics: cardiovascular and 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 30-80 595 • Cohort A: 2-dose regimen Primary endpoints: Infarct size as a percentage of left
Slide 99: AZD0449
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 100: AZD1402
Approved medicines Oncology Late-stage development AZD1402 (IL4 receptor alpha antagonist) Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase Ib Patients with mild asthma 84 PoM. Primary endpoint: • LPCD: Q3 2018 A dose-escalating, single blind trial to assess the
Slide 101: MEDI3506: COPD, atopic dermatitis, asthma
Approved medicines Oncology Late-stage development MEDI3506 (IL33 ligand mAb) Early development COPD, atopic dermatitis, asthma Trial Population Patients Design Endpoints Status CVRM Phase II Adult subjects with atopic 152 Randomised, blinded, placebo-controlled trial to determine the • Primary: cha
Slide 102: AZD7986
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 103: AZD8154
Approved medicines Oncology Late-stage development AZD8154 (PI3Kδ inhibitor) 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 104: AZD8871
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 105: AZD9567
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 106: AZD0284
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 107: MEDI0618
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 108: MEDI1341
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 109: AZD4041
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 110: MEDI7352
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 111: 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 112: 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 113: 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 114: Clinical trials appendix: Full year and Q4 2020 results update
Clinical trials appendix Full year and Q4 2020 results update