Slide 1: Clinical trials appendix Q1 2021 results update
Clinical trials appendix Q1 2021 results update
Slide 2: Movement since Q4 2020 update
Movement since Q4 2020 update New to Phase I New to Phase II New to Pivotal trial New to registration NME camizestrant (AZD9833) + palbociclib SERENA-4 selective oestrogen receptor degrader + CDK4/6 inhibitors 1st-line HR+ HER2- breast cancer datopotamab deruxtecan# TROPION-Lung01 TROP2 targeting an
Slide 3: Q1 2021 new molecular entity (NME) pipeline
Q1 2021 new molecular entity (NME)1 pipeline Phase I Phase II Phase III Under Review 19 New Molecular Entities 21 New Molecular Entities 12 New Molecular Entities 0 New Moelcular Entities AZD0466# adavosertib# camizestrant+palbociclib SERENA-4 Imfinzi#+tremelimumab Imfinzi#+MEDI0457# BCL2/xL haemato
Slide 4: Q1 2021 new molecular entity (NME) pipeline
Q1 2021 new molecular entity (NME)1 pipeline Phase I Phase II Phase III 13 New Molecular Entities 20 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 5: Q1 2021 lifecycle management (LCM) pipeline
Q1 2021 lifecycle management (LCM)1 pipeline Phase I Phase II Phase III Under Review 2 Projects 9 Projects 30 Projects 0 Projects Enhertu# (platform) DESTINY- Enhertu# (platform) DESTINY- Imfinzi# CALLA Calquence# Imfinzi#+CTx TOPAZ-1 Breast08 Breast07 PD-L1 adj. locally-advanced cervical BTK inhibi
Slide 6: Q1 2021 lifecycle management (LCM) pipeline
Q1 2021 lifecycle management (LCM)1 pipeline Phase I Phase II Phase III Under Review 0 Projects 3 Projects 10 Projects 1 Project Fasenra ARROYO Breztri Fasenra MESSINA Farxiga/Forxiga DAPA-CKD IL5R chronic spontaneous urticaria LABA/LAMA/ICS asthma IL5R eosinophilic esophagitis SGLT2 CKD Farxiga/For
Slide 7: Estimated key regulatory submission acceptances
Estimated key regulatory submission acceptances nirsevimab camizestrant + palbociclib breast cancer datopotamab deruxtecan NSCLC passive RSV immunisation SERENA-4 TROPION-Lung01 capivasertib + fulvestrant locally advanced or Imfinzi + tremelimumab + SoC urothelial AZD7442 SARS-CoV-2 PT027 asthma mBC
Slide 8: Designations
Designations 5 17 12 36 29 1 2 3 Accelerated approvals Breakthrough / PRIME / Sakigake Fast Track Priority Review / RTOR 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) Tag
Slide 9: Oncology – approved medicines and late-stage pipeline
Oncology – approved medicines and late-stage pipeline
Slide 10: 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: 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: 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: • FPCD: Q3 2020 MERMAID-1 Stage II and III NSCLC • Arm
Slide 13: Imfinzi +/- treme – lung cancer, advanced disease
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: 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: Imfinzi +/- treme – other cancers, advanced disease
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 1,215 • Arm 1: Imfinzi + tremelimumab + SoC Primary endpoint: • FPCD: Q4
Slide 16: Imfinzi +/- treme – other cancers, advanced disease
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: Lynparza – multiple cancers
Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) 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 18: 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: 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 Metastatic castration-resistant 904 • Arm 1: Lynparza + abiraterone Primary Endpoint: • FPCD: Q4 2018 PROpel prostate can
Slide 20: 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: 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 233 Randomised open label parallel assignment Primary end point ORR • FP
Slide 22: 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-over-expressing or mutated, 170 Non randomised parallel group assignment Primary endpoint ORR • FPCD: Q2
Slide 23: 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 DESTI
Slide 24: 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 25: 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 26: 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 27: Koselugo – paediatric NF1, solid tumours
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 28: Lumoxiti – blood cancer
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 29: Savolitinib – NSCLC and other cancers
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 30: Capivasertib – breast cancer, prostate cancer
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 • OS • FPCD: Q3 2019 CAPItello-290 metas
Slide 31: Monalizumab – cancers
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 32: Camizestrant – breast cancer
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 33: Datopotamab deruxtecan – NSCLC
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 34: Oncology – early-stage development
Oncology – early-stage development
Slide 35: 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 36: 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 37: 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 38: 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 39: AZD0466 – cancer
Approved medicines Oncology Late-stage development AZD0466 (Bcl2/xL inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced hematologic 10 Monotherapy dose escalation, consisting of two arms: • Primary: safety • FPCD: Q4 2019 malignancies or solid
Slide 40: MEDI1191 – cancer
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 41: AZD1390 – cancer
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 42: Adavosertib – ovarian, uterine serous, solid tumours
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 43: AZD2811NP – cancer
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 44: AZD4573 – cancer
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 45: Imaradenant – cancer
Approved medicines Oncology Late-stage development Imaradenant (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 tumo
Slide 46: AZD5305 – solid tumours
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 47: MEDI5395 – cancer
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 48: MEDI5752 – cancer
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 49: AZD5991 – cancer
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 50: Ceralasertib – cancer
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 51: AZD7648 – advanced solid tumours
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 52: AZD8701 – solid tumours
Approved medicines Oncology Late-stage development AZD8701 (FOXP3 antisense oligonucleotide) Early development Solid tumours Trial Population Patients Design Endpoints Status CVRM Phase I/Ib Advanced solid tumours 123 Dose escalation and dose expansion trial Primary endpoints: • FPCD: Q3 2020 NCT045
Slide 53: MEDI9253 – solid tumours
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 54: Oleclumab – cancer
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 55: IPH5201 – solid tumours
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 Patients With CKD 4,304 • Arm 1: Farxiga 10mg or 5 mg QD • Primary endpoint: time to the first • FP
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 acute ischaemic 11,000 • Arm 1: Brilinta 90mg BiD Primary endpoint: • FPCD:
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 20 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 – asthma
Approved medicines Oncology Late-stage development Breztri, Trixeo (PT010, LAMA/LABA/ICS, pMDI) 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 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, uncontrolled 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: • FPCD: Q2 2021 FJORD (newly diagnosed or relapsing) • Arm 2
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, COPD and CRSwNP
Approved medicines Oncology Late-stage development Tezepelumab (TSLP mAb) Early development Severe, uncontrolled asthma, COPD & CRSwNP 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 CASC
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 (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 76: Nirsevimab – infection
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 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: Other COVID-19 trials
Approved medicines Oncology Late-stage development Other 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: Q
Slide 80: BioPharmaceuticals – early-stage development
BioPharmaceuticals – early-stage development
Slide 81: Cotadutide – diabetes/CKD, NASH
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 82: Verinurad – CKD, HFpEF
Approved medicines Oncology Late-stage development Verinurad (URAT1 inhibitor) Early development CKD, HFpEF Trial Population Patients Design Endpoints Status CVRM Phase II Patients with: 861 • Arm A; Verinurad 12 mg + allopurinol 300 mg Ratio of urinary albumin to urinary • FPCD: Q3 2019 SAPPHIRE •
Slide 83: 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 84: 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: H2 2021 NCT04142424 6 cohorts with 6
Slide 85: AZD3427 – heart failure
Approved medicines Oncology Late-stage development AZD3427 (relaxin) Early development Heart failure Trial Population Patients Design Endpoints Status CVRM Phase I SAD – Healthy Volunteers 104 • Multi-center single and multiple ascending dose study (SAD Safety & Tolerability • FPCD: Q4 2020 MAD – He
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 79 SAD Primary: • FPCD: Q4 2020 • Safety and tolerability • LPCD: H2 2021 NCT04588727 Part A Dose escalation in 6 coho
Slide 87: 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 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 and CKD
Approved medicines Oncology Late-stage development AZD5718 (FLAP inhibitor) Early development Cardiovascular disease & Chronic Kidney 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 • Ar
Slide 90: 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 • LPCD: Q3 2019 NCT03593785 7 cohorts
Slide 91: 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 CKD 6 cohorts • Safety and tolerability NCT04365218 Arm 1: MEDI8367
Slide 92: 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 93: 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 94: Zibotentan – chronic kidney disease
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 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 IIa MEDI5884 Adults with stable 133 • MEDI5884 (5 dose cohorts) vs. placebo in • Safety profile in terms of AEs, vi
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 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 98: 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 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: 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 101: 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 102: AZD0284 – plaque psoriasis vulgaris
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 103: 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 104: 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 105: 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 106: 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 107: 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 108: 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 109: 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 110: Clinical trials appendix Q1 2021 results update
Clinical trials appendix Q1 2021 results update