Slide 1: Clinical trials appendix Q3 2019 results update
Clinical trials appendix Q3 2019 results update
Slide 2: Information on AstraZeneca clinical trials
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 September 2019, unles
Slide 3: Table of contents
Table of contents slide Movement since Q2 2019 update Q3 2019 NME pipeline Q3 2019 LCM pipeline Oncology Approved medicines and late-stage development Early-stage development Biopharmaceuticals Approved medicines and late-stage development Early-stage development 3
Slide 4: Movement since Q2 2019 update
Movement since Q2 2019 update New to Phase I New to Phase II New to Pivotal Study New to Registration NME NME NME NME AZD6615 oleclumab+AZD4635 nirsevimab# (MEDI8897) trastuzumab deruxtecan#¶ DESTINY-Breast01 [US] 1 hypercholesterolemia CV disease CD73 mAb + A2aR inhibitor prostate cancer RSV mAb-YT
Slide 5: Q3 2019 New Molecular Entity (NME) pipeline
Q3 2019 New Molecular Entity (NME)1 pipeline Phase I Phase II Phase III 20 New Molecular Entities 25 New Molecular Entities 14 New Molecular Entities AZD1390 Imfinzi#+tremelimumab adavosertib# Imfinzi#+tremelimumab capivasertib+chemotherapy CAPItello-290 Imfinzi#+tremelimumab+SoC NILE glioblastoma P
Slide 6: Q3 2019 New Molecular Entity (NME) pipeline
Q3 2019 New Molecular Entity (NME)1 pipeline Phase I Phase II Phase III 14 New Molecular Entities 21 New Molecular Entities 5 New Molecular Entities AZD0284 AZD9977 abediterol# cotadutide anifrolumab# TULIP RORg psoriasis/respiratory MCR cardiovascular LABA asthma/COPD GLP-1/glucagon type-2 diabetes
Slide 7: Q3 2019 Lifecycle Management (LCM) pipeline
Q3 2019 Lifecycle Management (LCM)1 pipeline Phase I Phase II Phase III Applications Under Review 1 Project 6 Projects 21 Projects 3 Projects Imfinzi#+CTx NIAGARA Imfinzi#+azacitidine# Imfinzi# Calquence# Calquence# PD-L1+CTx muscle invasive bladder PD-L1+azacitidine MDS PD-L1 solid tumours BTK inhi
Slide 8: Q3 2019 Lifecycle Management (LCM) pipeline
Q3 2019 Lifecycle Management (LCM)1 pipeline Phase I Phase II Phase III Applications Under Review 0 Projects 0 Projects 11 Projects 2 Projects Brilinta/Brilique HESTIA Brilinta/Brilique THEMIS P2Y12 paeds w/ sickle cell P2Y12 diabetes & CAD outcomes Brilinta/Brilique THALES Nexium (CN only) P2Y12 st
Slide 9: Estimated key regulatory submission acceptances
Estimated key regulatory submission acceptances PT027 asthma tezepelumab asthma NAVIGATOR roxadustat anaemia in CKD (US) Imfinzi +tremelimumab bladder Imfinzi +tremelimumab HCC Fasenra severe asthma (China) OLYMPUS/ROCKIES DANUBE HIMALAYA selumetinib NF1 Imfinzi + tremelimumab HNSCC Imfinzi +tremeli
Slide 10: Designations
Designations 4 Accelerated approvals 13 Breakthrough / PRIME / Sakigake 10 Fast Track 23 Priority Review 25 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 EG
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 III 1st-line EGFRm NSCLC 586 Arm 1: Tagrisso plus Pemetrexed/Carboplatin or • Primary endpoint: PFS •
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 +/- tremelimumab - Lung cancer, advanced
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- SCLC 1L 600 • Arm 1: Imfinzi + tremelimumab (4 doses) Primary endpoints: • FPCD: Q4
Slide 16: 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: Q3 2018 POTOMAC can
Slide 17: Imfinzi +/- treme - Other cancers, late disease
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 years • Primary endpoint:
Slide 20: 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 1,056 Non tBRCAm (tumour BRCA) patients Primary endpoint: • FPCD: Q1 2019 • Arm 1: bevacizum
Slide 21: Lynparza - Other combinations
Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development Other combinations Trial Population Patients Design Endpoints Status CVRM Phase III Advanced ovarian cancer 1L 806 • Arm 1: Lynparza maintenance therapy for two years or until Primary endpoint: • FPCD: Q2
Slide 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 B) • FPCD: Q2 2015
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 40 Dose escalation and expansion trial of the combination of • Safety • FPCD: Q1 2015 ACE-LY-001 Calque
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 Ib/II ≥ 2L glioblastoma multiforme 52 • Arm A: Calquence 200mg BID • Safety, ORR • FPCD: Q1 2016 ACE-ST-209 • Arm B: Calquence 4
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 NF1 50 (stratum 1) • Single arm: selumetinib 25mg/m2 BID with 2 strata: • Complete partial a
Slide 30: 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 31: 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 32: 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 TNBC • A
Slide 33: Oncology - early-stage development
AstraZeneca Oncology - early-stage development
Slide 34: 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 35: 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 36: 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 37: 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 38: 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 39: AZD1390 - Cancer
Approved medicines Oncology Late-stage development AZD1390 (ATM inhibitor) Early development Cancer Trial Population Subjects Design Endpoints Status CVRM Phase I Healthy volunteers 8 • PET trial • Brain distribution of AZD1390 to assess if • FPCD: Q4 2017 [11C]AZD1390 crosses the blood brain • LPCD
Slide 40: 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 41: 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 42: 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 43: 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 44: 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 295 Phase Ia – solid tumours or mCPRC: Primary outcome measure: • FPCD: Q2 2016 advanced solid tumours • AZD4635
Slide 45: 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 46: 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 47: 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 Monotherapy dose escalation in advanced solid tumours and • Primary: safety • FPCD: Q2 2017 tumours, lym
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 Advanced solid tumours 263 Open-label, dose-escalation and dose-expansion Primary endpoints: • FPCD: Q2 2018 • dose-escalat
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 Relapsed/refractory 48 • Arm1: monotherapy dose escalation in relapsed/refractory • Primary: safety • FPCD: Q3 2017 haematologic maligna
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: Danvatirsen - Cancer
Approved medicines Oncology Late-stage development Danvatirsen (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/I
Slide 52: 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 53: 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 54: 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 55: AZD9833 - Breast cancer
Approved medicines Oncology Late-stage development AZD9833 (selective oestrogen 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 measur
Slide 56: BioPharmaceuticals - approved medicines and late-stage pipeline
AstraZeneca BioPharmaceuticals - 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 DECL
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 CHF patients with HFrEF 4,744 • Arm 1: Farxiga 10mg or 5 mg QD + SoC therapy • Primary endpoint: ti
Slide 59: Brilinta - Cardiovascular risk reduction
Approved medicines Oncology Late-stage development Brilinta (P2Y12 receptor antagonist) Early development Cardiovascular risk reduction Trial Population Patients Design Endpoints (primary) Status CVRM Phase III Patients with type-2 diabetes 19,000 • Arm 1: Brilinta 60mg BiD • Primary endpoint: compo
Slide 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 Late-stage development Roxadustat (HIF-PHI) 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 dialysis
Slide 63: Roxadustat - Anaemia
Approved medicines Oncology Late-stage development Roxadustat (HIF-PHI) 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 patients
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: 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 67: 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 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 asthma on ICS-LABA 120 Open label Fasenra 30mg Q4w • Primary endpoint: percentage of patients/ • FPCD: Q4 2016
Slide 72: Fasenra - Nasal polyposis, other
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development Nasal polyposis, other 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
Slide 73: Fasenra - COPD
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development COPD Trial Population Patients Design Endpoints Status CVRM Phase III Patients with moderate to very 1216 • Double-blind, placebo controlled, single dose (100mg q8w) • Primary endpoint: annualized rate of • FPCD
Slide 74: 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 1,060 • Arm 1: tezepelumab s.c. • Primary endpoint: Annual asthma • FPCD: Q1 2018 NAVIGATOR Age 12-80
Slide 75: Tezepelumab - Atopic dermatitis, COPD
Approved medicines Oncology Late-stage development Tezepelumab (TSLP mAb) Early development Atopic dermatitis, COPD Trial Population Patients Design Endpoints Status CVRM Phase IIb Patients with chronic atopic 300 A dose-ranging, double-blind, placebo-controlled study to evaluate The effect of tezep
Slide 76: Anifrolumab - Lupus (SLE / LN)
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 77: BioPharmaceuticals - early-stage development
AstraZeneca BioPharmaceuticals - early-stage development
Slide 78: 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 79: 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 80: Cotadutide - Diabetes/obesity, NASH
Approved medicines Oncology Late-stage development Cotadutide (MEDI0382, GLP-1-glucagon agonist) Early development Diabetes/obesity, NASH Trial Population Patients Design Endpoints Status CVRM Phase II Overweight and 27 • Cotadutide or placebo s.c. • Primary: efficacy body weight loss • FPCD: Q4 201
Slide 81: 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 82: 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 83: 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 84: 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) CAD 138 • Arm 1: AZD5718 Dose A • Primary endpoint: PD effect of AZD5718 • FPCD: Q4 2017 • Arm 2: AZD5718 Dose B
Slide 85: AZD6615 - Hypercholesterolemia
Approved medicines Oncology Late-stage development AZD6615 (anti-hypercholesterolemia) Early development Hypercholesterolemia Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 40 SAD Primary: • FPCD: Q3 2019 • Safety and tolerability NCT04055168 3 cohorts of non-Asian s
Slide 86: 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 130 • 5 part trial • Safety and tolerability • FPCD: Q1 2018 • Part A : SAD • Pharmacokinetics • Data anticipated:
Slide 87: 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 • LPCD: Q3 2019 NCT03593785 7 cohort
Slide 88: 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 89: AZD9977 - Heart failure with preserved ejection fraction
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 90: 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 91: 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 92: 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 93: AZD1402 - Asthma
Approved medicines Oncology Late-stage development AZD1402 (IL4 receptor antagonist) Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase Ib Patients with mild asthma 70 PoM. Primary endpoint: • FPCD: Q3 2018 A dose-escalating, single blind trial to assess the • Safe
Slide 94: 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 95: 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 96: 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 97: 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 98: 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 PK, PD Primary endpoint: • FPCD: Q3 2019 and safet
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 s
Slide 100: AZD8154 - Asthma
Approved medicines Oncology AZD8154 (PI3Kgδ inhibitor) Late-stage development Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 54 SAD Primary endpoint: • FPCD: Q3 2018 A Phase I trial to assess the safety, tolerability and PK of • Safety and to
Slide 101: AZD8871 - Respiratory
Approved medicines Oncology Late-stage development AZD8871 (MABA, inhaled) Early development Respiratory Trial Population Patients Design Endpoints Status CVRM Phase IIa Patients with COPD 73 Randomised, double-blind, placebo and active-controlled Primary endpoint: • FPCD: Q4 2018 crossover trial. E
Slide 102: AZD9567 - Respiratory
Approved medicines Oncology Late-stage development AZD9567 (SGRM, oral) Early development Respiratory Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 71 MAD trial with a total of 6 dose levels of AZD9567: 10 mg, 20mg, Primary endpoint: • FPCD: Q2 2016 40mg, 80mg and 1
Slide 103: 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 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 3rd 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 DRAFT Q3 2019 results update
Clinical trials appendix DRAFT Q3 2019 results update