Slide 1: Clinical trials appendix Q2 2019 results update
Clinical trials appendix Q2 2019 results update
Slide 2: About the clinical trials information
The following information about AstraZeneca clinical trials in Phases I-IV has been created with selected information from clinicaltrials.gov to facilitate understanding of key aspects of ongoing clinical programmes and is correct to the best of the Company’s knowledge as of 30 June 2019, unless oth
Slide 3: Table of contents
Table of contents slide Movement since Q1 2019 update Q2 2019 NME pipeline Q2 2019 LCM pipeline Oncology Approved medicines and late-stage development Early-stage development Cardiovascular, Renal & Metabolism (CVRM), Respiratory & Other medicines Approved medicines and late-stage development Early-
Slide 4: Movement since Q1 2019 update
Movement since Q1 2019 update New to Phase I New to Phase II New to Pivotal Study New to Registration NME NME NME MEDI1191 Tagrisso + savolitinib# SAVANNAH capivasertib# + Chemo CAPItello-290 IL-12 mRNA solid tumours EGFR inhibitor + MET inhibitor advanced EGFRm NSCLC AKT inhibitor + Chemo 1st line
Slide 5: Q2 2019 NME pipeline
Q2 2019 New Molecular Entity (NME)1 pipeline Phase I Phase II Phase III 21 New Molecular Entities 22 New Molecular Entities 17 New Molecular Entities Imfinzi#+tremelimumab+chemo capivasertib+chemotherapy trastuzumab deruxtecan# AZD1390 adavosertib# Imfinzi#+tremelimumab PD-L1+CTLA-4 1L PDAC oesophag
Slide 6: Q2 2019 NME pipeline
Q2 2019 New Molecular Entity (NME)1 pipeline Phase I Phase II Phase III Applications Under Review 13 New Molecular Entities 22 New Molecular Entities 3 New Molecular Entities 0 New Molecular Entities AZD0284 abediterol# cotadutide anifrolumab# TULIP RORg psoriasis/respiratory LABA asthma/COPD GLP-1/
Slide 7: Q2 2019 LCM pipeline
Q2 2019 Lifecycle Management (LCM)1 pipeline Phase I Phase II Phase III Applications Under Review 0 Projects 0 Projects 12 Projects 3 Projects Brilinta/Brilique HESTIA Farxiga/Forxiga DECLARE P2Y12 paeds w/ sickle cell outcomes Brilinta/Brilique THALES Nexium (CN only) P2Y12 stroke stress ulcer prop
Slide 8: Q2 2019 LCM pipeline
Q2 2019 Lifecycle Management (LCM)1 pipeline Phase I Phase II Phase III Applications Under Review 1 Project 4 Projects 24 Projects 0 Projects Imfinzi#+azacitidine# Imfinzi# Calquence# Imfinzi#+CTx NIAGARA PD-L1+azacitidine MDS PD-L1 solid tumours BTK inhibitor 1st line MCL PD-L1+CTx muscle invasive
Slide 9: Estimated key regulatory submission acceptances
Estimated key regulatory submission acceptances roxadustat anaemia in CKD (US) Imfinzi + tremelimumab DANUBE PT027 asthma selumetinib SPRINT Imfinzi + tremelimumab KESTREL capivasertb + CTx CAPItello Lynparza + Imfinzi + bevacizumab DUO-O NME Imfinzi +/- tremelimumab CASPIAN Imfinzi + tremelimumab N
Slide 10: Designations
Designations 4 Accelerated approvals 9 Breakthrough Therapy 8 Fast Track 22 Priority Review / PRIME 24 Orphan Drug 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) Tagrisso EGFRm T
Slide 11: Oncology – approved medicines and late-stage pipeline
AstraZeneca Oncology – approved medicines and late-stage pipeline
Slide 12: 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 13: 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 II Advanced EGFRm NSCLC 150 Modular design platform study: • Primary endpoint: ORR • FPCD: Q3 2019 ORC
Slide 14: Imfinzi – NSCLC, early use
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development NSCLC, early use Trial Population Patients Design Endpoints Status CVRM Phase III Adjuvant NSCLC patients 1,360 • Arm 1: Imfinzi mg/kg i.v. Q4W x 12m Primary endpoint: • FPCD: Q1 2015 ADJUVANT BR.31 IB (≥4cm) –
Slide 15: Imfinzi +/- treme – advanced lung cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development Lung cancer, advanced Trial Population Patients Design Endpoints Status CVRM Phase III Limited disease- Small cell 600 • Arm 1: Imfinzi + tremelimumab (4 doses) Primary endpoints: • FPCD:
Slide 16: Imfinzi +/- treme – early disease cancers
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 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: • FP
Slide 17: Imfinzi +/- treme – late disease cancers
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development Other cancers, late disease Trial Population Patients Design Endpoints Status CVRM Phase III Cis-eligible and ineligible 1,005 • Arm 1: Imfinzi + tremelimumab Primary endpoints: • FPCD: Q4
Slide 18: Imfinzi +/- treme – other cancers
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development Other cancers Trial Population Patients Design Endpoints Status CVRM Phase III Advanced solid malignancies 1,200 • Arm 1: Imfinzi • Primary endpoint: Safety • FPCD: Q2 2017 STRONG • Arm 2:
Slide 19: Lynparza – ovarian and other cancers
Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development Ovarian and other cancers Trial Population Patients Design Endpoints Status CVRM Phase III BRCAm maintenance ovarian 391 • Arm 1: Lynparza tablets BID maintenance therapy for two • Primary endpoint: PFS •
Slide 20: Lynparza – Imfinzi combinations
Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development Imfinzi combinations, cancers Trial Population Patients Design Endpoints Status CVRM Phase III Advanced ovarian cancer 1L 1,056 Non tBRCAm (tumour BRCA) patients Primary endpoint: • FPCD: Q1 2019 • Arm 1:
Slide 21: Lynparza – combinations, cancers
Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development Combinations, cancers 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:
Slide 22: 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 • FPCD: Q2 2015 ACE
Slide 23: 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 126 Dose escalation and expansion trial of the combination of • Safety • FPCD: Q1 2015 ACE-LY-001 Calqu
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 I Japanese Adults with 34 • Calquence monotherapy • Safety • FPCD: Q2 2017 Advanced B-cell Malignancies • Dose confirmation and
Slide 25: Calquence – other cancers
Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development Other cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase II ≥ 2L advanced or metastatic 74 • Arm A: pembrolizumab • ORR • FPCD: Q2 2015 ACE-ST-006 HNSCC • Arm B: Calquence + pembrolizum
Slide 26: 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 study • Primary endpoint: rate of du
Slide 27: Trastuzumab deruxtecan – breast and gastric cancers
Approved medicines Oncology Late-stage development Trastuzumab deruxtecan (DS-8201, HER2 ADC) Early development Breast and gastric cancers Trial Population Patients Design Endpoints Status CVRM Phase II HER2-positive, unresectable and/or 230 Randomised, open label, sequential assignment Primary endp
Slide 28: Trastuzumab deruxtecan – other cancers
Approved medicines Oncology Late-stage development Trastuzumab deruxtecan (DS-8201, HER2 ADC) Early development Other cancers Trial Population Patients Design Endpoints Status CVRM Phase II HER2-expressing advanced colorectal 90 Non randomised single group assignment Primary end point ORR • FPCD Q1
Slide 29: Selumetinib – paediatric neurofibromatosis type 1
Approved medicines Oncology Late-stage development Selumetinib (MEK inhibitor) Early development Paediatric neurofibromatosis type 1 Trial Population Patients Design Endpoints Status CVRM Phase II Paediatric neurofibromatosis 50 (stratum 1) • Single arm: selumetinib 25mg/m2 BID with 2 strata: • Comp
Slide 30: Savolitinib – papillary renal cell, NSCLC and other cancers
Approved medicines Oncology Late-stage development Savolitinib (MET inhibitor) Early development Papillary renal cell, NSCLC and other cancers Trial Population Patients Design Endpoints Status CVRM Phase III MET-driven, papillary renal 60 • Arm 1: savolitinib 600mg QD • Primary endpoint: PFS • FPCD:
Slide 31: 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 study • PFS • FPCD Q3 2019 metastatic triple n
Slide 32: Cediranib – ovarian cancer
Approved medicines Oncology Late-stage development Cediranib (VEGF receptor inhibitor) Early development Ovarian cancer Trial Population Patients Design Endpoints Status CVRM Phase IIb PRR ovarian cancer - heavily 62 • Cediranib 30mg + Lynparza 200mg BID • ORR, DoR, DCR, QoL. OS; Safety • FPCD: Q1 2
Slide 33: Oncology – early-stage development
AstraZeneca Oncology – early-stage development
Slide 34: AZD1390 – cancer
Approved medicines Oncology Late-stage development AZD1390 (ATM inhibitor, blood brain barrier) Early development Cancer Trial Population Subjects Design Endpoints Status CVRM Phase I Healthy volunteers 8 • PET trial • Brain distribution of AZD1390 to assess • FPCD: Q4 2017 if [11C]AZD1390 crosses t
Slide 35: Adavosertib – ovarian cancer, solid tumours
Approved medicines Oncology Late-stage development Adavosertib (AZD1775, WEE-1 inhibitor) Early development Ovarian cancer, solid tumours Trial Population Patients Design Endpoints Status CVRM Phase II Platinum-resistant (PR) 96 • Arm B: paclitaxel + adavosertib • Primary endpoint: ORR • FPCD: Q1 20
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 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: 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 GEJ adenocarcinoma 114 • Arm A: Imfinzi + tremelimumab 2L • Primary endpoints: Safety & tolerability, • FPCD:
Slide 38: Imfinzi + monalizumab – cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) + Early development monalizumab (NKG2a mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase I/II Advanced solid tumours 501 Escalation phase Primary endpoints: • FPCD: Q2 2016 • monalizumab + Imfinzi i.v. • Sa
Slide 39: Imfinzi + MEDI0457 – SCCHN
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) + Early development MEDI0457 (DNA HPV Vaccine) Squamous cell carcinoma of the Head and Neck (SCCHN) CVRM Trial Population Patients Design Endpoints Status Phase Ib/IIa HPV Associated 50 Multi-centre, open label trial to evaluate
Slide 40: Oleclumab – cancer
Approved medicines Oncology Late-stage development Oleclumab (MEDI9447, CD73 mAb) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced malignancies 310 Dose escalation phase Primary endpoints: • FPCD: Q3 2015 • oleclumab i.v. • Safety • Data anticipated: 2
Slide 41: AZD2811 – cancer
Approved medicines Oncology Late-stage development AZD2811 (AURN) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 72 • Arm 1: AZD2811 dose escalation • Safety and tolerability • FPCD: Q4 2015 • Arm 2: AZD2811 dose expansion SCLC • PK and efficacy
Slide 42: 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 Dose escalation in relapsed/refractory haematological Primary: • FPCD: Q4 2017 haematologic malignancies malignan
Slide 43: AZD4635 – cancer
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 104-118 • Phase Ia: dose escalation to determine the MTD of AZD4635 Primary outcome measure: • FPCD: Q2 2016 adv
Slide 44: AZD5069 – cancer
Approved medicines Oncology Late-stage development AZD5069 (CXCR2 antagonist) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase Ib/II Metastatic pancreatic ductal 16 Dose escalation and expansion arms: • Safety/efficacy trial • FPCD: Q1 2016 carcinoma • LPCD: Q3 2
Slide 45: AZD5153 – cancer
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 Dose Escalation advanced solid and lymphomas • Primary: safety • FPCD: Q2 2017 tumours, lymphomas eight
Slide 46: AZD5991 – cancer
Approved medicines Oncology Late-stage development AZD5991 (MCL1 inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/refractory 48 • Dose escalation in relapsed/refractory haematological • Primary: safety • FPCD: Q3 2017 haematologic malignanci
Slide 47: 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 48: AZD9150 – cancer
Approved medicines Oncology Late-stage development AZD9150 (STAT3 inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase Ib/II HNSCC 405 Dose escalation advanced solid and blood cancers • Safety/efficacy trial • FPCD: Q3 2015 • Arm A1: AZD9150/Imfinzi • LPCD
Slide 49: AZD9496 – breast cancer
Approved medicines Oncology Late-stage development AZD9496 (selective estrogen receptor degrader) 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 measu
Slide 50: AZD9833 – breast cancer
Approved medicines Oncology Late-stage development AZD9833 (selective estrogen receptor degrader) Early development Breast cancer Trial Population Patients Design Endpoints Status CVRM Phase I ER+ breast cancer 240 • This is a Phase I open label multicentre trial of AZD9833 • Primary outcome measure
Slide 51: MEDI2228 – cancer
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 129 First-time-in-human Phase I, multi-centre, open-label, single-arm, Primary endpoints: •
Slide 52: MEDI5083 + Imfinzi – cancer
Approved medicines Oncology Late-stage development MEDI5083 (CD40 Ligand fusion protein ) Early development + Imfinzi (PD-L1 mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase I Advanced solid tumours 204 Dose-escalation phase Primary endpoints: • FPCD: Q1 2017 • Part 1: MEDI50
Slide 53: 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 Advanced solid tumour 263 Open-label, Dose-escalation and Dose-expansion Primary endpoints: • FPCD: Q2 2018 • Dose-escalati
Slide 54: MEDI7247 – cancer
Approved medicines Oncology Late-stage development MEDI7247 (PBD ADC mAb) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/refractory 408 First-time-in-human Phase I, multi-centre, open-label, single-arm, • Primary endpoint: safety • FPCD: Q2 2017 NCT0
Slide 55: MEDI1191 – cancer
Approved medicines Oncology Late-stage development MEDI1191 (IL-12 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 56: CVRM, Respiratory and Other medicines – approved medicines and late-stage pipeline
AstraZeneca CVRM, Respiratory and Other medicines – approved medicines and late-stage pipeline
Slide 57: Farxiga – diabetes
Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development Diabetes Trial Population Patients Design Endpoints Status CVRM Phase III/IV Type-2 diabetes 17,190 • Arm 1: Farxiga 10mg QD + SoC therapy QD • Primary endpoints: Superiority for MACE • FPCD: Q2 2013 DECLA
Slide 58: Farxiga – diabetes / cardiovascular risk reduction
Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development Diabetes / cardiovascular risk reduction Trial Population Patients Design Endpoints Status CVRM Phase III Chronic Heart Failure (CHF) 4,744 • Arm 1: Farxiga 10mg or 5 mg QD + standard of care therapy • Pri
Slide 59: Brilinta – cardiovascular risk reduction
Approved medicines Oncology Late-stage development Brilinta (ADP 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: composi
Slide 60: Epanova – hypertriglyceridaemia
Approved medicines Oncology Late-stage development Epanova (omega-3 carboxylic acids) Early development Hypertriglyceridaemia Trial Population Patients Design Endpoints Status CVRM Phase III Patients with 13,000 • Arm 1: Epanova 4g QD + statin • Primary endpoint: composite of MACE • FPCD: Q4 2014 ST
Slide 61: Lokelma – hyperkalaemia
Approved medicines Oncology Late-stage development Lokelma (sodium zirconium cyclosilicate) Early development Hyperkalaemia Trial Population Patients Design Endpoints Status CVRM Phase III Hyperkalaemia 248 Open-label Lokelma 10g TID for 48 hours followed by: • Primary endpoint: maintenance of • FPC
Slide 62: Roxadustat – anaemia
Approved medicines Oncology Roxadustat (China: 爱瑞卓) (HIF-PHI inhibitor) Late-stage development Early development Anaemia Trial Population Patients Design Endpoints Status CVRM Phase III ANDES Anaemia in CKD (Chronic 922 • Arm 1: roxadustat • Primary endpoint: Haemoglobin • FPCD: Q4 2012 Kidney Disea
Slide 63: Roxadustat – anaemia
Approved medicines Oncology Roxadustat (China: 爱瑞卓) (HIF-PHI inhibitor) Late-stage development Early development Anaemia Trial Population Patients Design Endpoints Status CVRM Phase III HIMALAYAS Anaemia in newly initiated 900 • Arm 1: roxadustat • Primary endpoint: Haemoglobin • FPCD: Q4 2013 dialy
Slide 64: 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 • FP
Slide 65: 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 66: Bevespi Aerosphere – COPD
Approved medicines Oncology Late-stage development Bevespi Aerosphere (LAMA/LABA, pMDI) Early development COPD Trial Population Patients Design (G = glycopyrronium, F = formoterol fumarate) Endpoints Status CVRM Phase IIIb Moderate to very severe 1,000 Treatments (24-week treatment period) Co-primar
Slide 67: Breztri – COPD
Approved medicines Oncology Late-stage development Breztri (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 (Budesonide,
Slide 68: Daliresp/Daxas – COPD
Approved medicines Oncology Late-stage development Daliresp/Daxas (PDE4 inhibitor, oral) Early development COPD Trial Population Patients Design Endpoints Status CVRM Phase IV COPD 2,354 • 52W, randomised, DB with Daliresp 500µg OD vs. placebo, in • Primary endpoint: rate of moderate or • FPCD: Q4 2
Slide 69: Fasenra – severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III A multi-centre, open-label, 770 • Arm 1: Fasenra 30mg Q4W s.c. • Primary endpoint: safety and tolerability • FPCD: Q2
Slide 70: Fasenra – severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe asthma, inadequately 2,550 • Arm 1: Fasenra 30mg Q4W s.c. • Primary endpoint: safety and tolerability • FPCD: Q
Slide 71: Fasenra – severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe uncontrolled asthma 230 • Arm 1: Fasenra 30mg Q4W s.c. • Primary endpoint: onset and • FPCD: Q4 2016 SOLANA des
Slide 72: Fasenra – nasal polyps
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development Nasal polyps Trial Population Patients Design Endpoints Status CVRM Phase III Patients with severe bilateral 400 • Arm 1: Fasenra 30mg Q8W s.c. • Primary endpoint: effect of Fasenra on • FPCD: Q1 2018 OSTRO nasa
Slide 73: PT027 – asthma
Approved medicines Oncology Late-stage development PT027 (ICS/SABA, 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: Tezepelumab – severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Tezepelumab (TSLP mAb) Early development Severe, uncontrolled asthma, atopic dermatitis Trial Population Patients Design Endpoints Status CVRM Phase III Severe asthma 1,060 • Arm 1: tezepelumab s.c. • Primary endpoint: Annual asthma • FPCD: Q1 2018
Slide 75: Anifrolumab – SLE / LN
Approved medicines Oncology Late-stage development Anifrolumab (type I interferon receptor mAb) Early development 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 in SLE
Slide 76: CVRM, Respiratory and Other medicines – early-stage development
AstraZeneca CVRM, Respiratory and Other medicines – early-stage development
Slide 77: Verinurad – CKD
Approved medicines Oncology Late-stage development Verinurad (RDEA3170, URAT1 inhibitor) Early development CKD Trial Population Patients Design Endpoints Status CVRM Phase II CKD patients with 60 • Arm A: verinurad 9 mg and febuxostat 80 mg To assess the effects of intensive uric acid • FPCD: Q2 201
Slide 78: AZD0449 – asthma
Approved medicines Oncology Late-stage development AZD0449 (inhaled JAK-1 inhibitor) Early development Asthma Trial Population Patients Design Endpoints Status CVRM AZD0449 Healthy subjects and patients 156 SAD/MAD/Bridge trial (UK) Primary endpoint: • FPCD: Q4 2018 with mild asthma Part 1 SAD • Saf
Slide 79: AZD4831 – cardiovascular disease
Approved medicines Oncology Late-stage development AZD4831 (MPO inhibitor) Early development Cardiovascular disease Trial Population Patients Design Endpoints Status CVRM AZD4831 (MPO) Healthy subjects c. 96 SAD trial (one trial site in Germany) • Safety and tolerability • FPCD: Q3 2016 • Planned to
Slide 80: AZD5718 – cardiovascular disease
Approved medicines Oncology Late-stage development AZD5718 (FLAP inhibitor) Early development Cardiovascular disease Trial Population Patients Design Endpoints Status CVRM AZD5718 (FLAP) Healthy subjects 96 SMAD trial (one trial site in UK) • Safety and tolerability • FPCD: Q1 2016 SAD • PK paramete
Slide 81: AZD8233 – hypercholesterolemia
Approved medicines Oncology Late-stage development AZD8233 (anti-hypercholesterolemia) Early development Hypercholesterolemia Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 56 SAD Primary: • FPCD: Q3 2018 • Safety and tolerability NCT03593785 7 cohorts with 6 subject
Slide 82: 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 83: AZD9977 – HFpEF
Approved medicines Oncology Late-stage development AZD9977 Early development Heart failure with preserved ejection fraction Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 27 MAD Primary: • FPCD: Q1 2018 • Safety and tolerability • LPCD: Q2 2018 NCT03435276 Dose escal
Slide 84: Cotadutide – diabetes/obesity
Approved medicines Oncology Late-stage development Cotadutide (MEDI0382, GLP-1-glucagon agonist) Early development Diabetes/obesity Trial Population Patients Design Endpoints Status CVRM Phase I Healthy adult subjects 64 • SAD s.c. administration • Primary: safety profile in terms of adverse events,
Slide 85: Cotadutide – diabetes/obesity
Approved medicines Oncology Late-stage development Cotadutide (MEDI0382, GLP-1-glucagon agonist) Early development Diabetes/obesity Trial Population Patients Design Endpoints Status CVRM Phase I Healthy adult subjects 22 • Open label, one sequence, cross-over • Effect of MEDI0382 on PK & PD of warfa
Slide 86: Cotadutide – diabetes/obesity
Approved medicines Oncology Late-stage development Cotadutide (MEDI0382, GLP-1-glucagon agonist) Early development Diabetes/obesity Trial Population Patients Design Endpoints Status CVRM Phase II Overweight and 27 • MEDI0382 or placebo s.c. • Primary: efficacy body weight loss • FPCD: Q4 2018 NCT035
Slide 87: MEDI7219 – diabetes
Approved medicines Oncology Late-stage development MEDI7219 (anti-diabetic) Early development Diabetes Trial Population Patients Design Endpoints Status CVRM Phase I Healthy Volunteers 104 • 4 part trial • Safety and tolerability • FPCD: Q1 2018 • Part A : SAD • Pharmacokinetics • Data anticipated:
Slide 88: 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 30-80 414 • Cohort A: 2-Dose Regimen Primary endpoints: Infarct size as a percentage of left
Slide 89: AZD1402 – asthma
Approved medicines Oncology Late-stage development AZD1402 (IL4 receptor antagonist) Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects Inhaled: 56 SAD. Primary endpoint: • FPCD: Q4 2017 A dose escalating single blind trial to assess the safety,
Slide 90: AZD1419 – asthma
Approved medicines Oncology Late-stage development AZD1419 (TLR9 agonist) Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase IIa Adults with eosinophilic, 81 • Arm 1: AZD1419, once-weekly adaptive dosing (4mg, 1mg, • Time to loss of asthma control • FPCD: Q4 2016 I
Slide 91: AZD7594 – asthma
Approved medicines Oncology Late-stage development AZD7594 (SGRM, inhaled) Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase I Adolescent asthma patients 24 An Open-Label, Multi-Centre, Phase I Study to Assess the Primary endpoint: • FPCD: Q3 2019 Pharmacokinetics
Slide 92: 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 s
Slide 93: AZD8154 – asthma
Approved medicines Oncology Late-stage development AZD8154 (PI3Kgδ inhibitor) Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 54 SAD Primary endpoint: • FPCD: Q3 2018 A Phase I trial to assess the safety, tolerability and • Safety and tolerabi
Slide 94: 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 95: 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 96: MEDI3506 – COPD
Approved medicines Oncology Late-stage development MEDI3506 (IL-33 mAb) ligand Early development Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase I (Combined SAD / SAD: Healthy subjects with SAD: 56 SAD: • Safety and tolerability • FPCD: Q2 20
Slide 97: 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 98: 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 Phase I, randomised, single-blind, placebo-controlled trial to • Safety and tolerability • FPCD: Q1 2016
Slide 99: 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 100: MEDI0700 – SLE
Approved medicines Oncology Late-stage development MEDI0700 - AMG 570 (Anti-B7RP-1 mAb/BAFF) Early development Systemic lupus erythematosus (SLE) Trial Population Patients Design Endpoints Status CVRM Phase Ia Healthy volunteers 56 Single Ascending Dose • Safety and tolerability • FPCD: Q1 2016 • Ar
Slide 101: 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 102: MEDI1814 – Alzheimer's disease
Approved medicines Oncology Late-stage development MEDI1814 (amyloid beta mAb) Early development Alzheimer’s disease Trial Population Patients Design Endpoints Status CVRM Phase I Alzheimer’s disease & healthy 121 • SAD & MAD • Safety, tolerability • FPCD: Q2 2014 elderly • Up to 10 i.v. cohorts are
Slide 103: 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 11 i.v.
Slide 104: 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 2rd line CKD Chronic Kidney Disease FPDC First patient commenced dosing 5-FU 5-fluorouracil CLL Chronic lymphocytic leukaemia FPG Fasting plasma
Slide 105: 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 106: Clinical trials appendix Q2 2019 results update
Clinical trials appendix Q2 2019 results update