Slide 1: Clinical Trials Appendix Q2 2018 results update
Clinical Trials Appendix Q2 2018 results update
Slide 2: About the clinical trial information
The following information about AstraZeneca clinical trials in Phases I-IV has been created with selected information from https://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 2018, un
Slide 3: List of abbreviations
List of abbreviations ADA Anti-Drug Antibody ICS Inhaled Corticosteroid pMDI Pressurised Metered Dose Inhaler ADC Antibody-Drug Conjugate IM Intra Muscular PoC Proof of Concept AE Adverse Event IR Immediate Release PR Partial Response AUC Area Under Curve IV Intravenous Q2W Quaque (every) Two Weeks
Slide 4: Table of contents
Table of contents slide Early development - IMED (AstraZeneca research & early development) Movement since Q1 2018 results announcement Oncology Q2 2018 NME pipeline CVRM Q2 2018 LCM pipeline Respiratory Other Approved medicines Oncology Cardiovascular, Renal & Metabolism (CVRM) Early development -
Slide 5: Movement since Q1 2018 update
Movement since Q1 2018 update New to Phase I New to Phase II New to Pivotal Study New to Registration NMEs Life-cycle Management Life-cycle management MEDI5752 Imfinzi+CRT PACIFIC-2 saxagliptin/dapagliflozin/metformin [EU] 1 PD-1/CTLA-4 bispecific mAb solid tumours PD-L1 mAb locally-advanced (stage
Slide 6: Q2 2018 New Molecular Entity (NME) Pipeline
Q2 2018 New Molecular Entity (NME)1 Pipeline Phase I Phase II Phase III Applications Under Review 30 Projects 27 Projects 7 Projects 2 Projects Small molecule Large molecule Small molecule Large molecule Small molecule Small molecule AZD0156 Imfinzi#+monalizumab# adavosertib# abediterol# Imfinzi#+ME
Slide 7: Q2 2018 Lifecycle Management (LCM) Pipeline
Q2 2018 Lifecycle Management (LCM)1 Pipeline Phase I Phase II Phase III Applications Under Review 0 Projects 7 Projects 21 Projects 5 Projects Small molecule Small molecule Large molecule Small molecule Large molecule Calquence# Calquence# Brilinta/Brilique THALES Imfinzi# PEARL (China) Bydureon EXS
Slide 8: Q2 2018 Lifecycle Management (LCM) Pipeline
Q2 2018 Lifecycle Management (LCM)1 Pipeline Oncology Combinations Phase I Phase II Phase III Applications Under Review 17 Projects 6 Projects 8 Projects 0 Projects Large molecule Calquence#+AZD6738 Imfinzi#+oleclumab Imfinzi#+tremelimumab Imfinzi#+tremelimumab DANUBE BTK+ATR haematalogical tumours
Slide 9: Estimated key regulatory submission acceptances timeline
Estimated key regulatory submission acceptances timeline Epanova anifrolumab tezepelumab (NAVIGATOR) roxadustat (US) Lokelma (JP) savolitinib PT010 - COPD selumetinib - NF-1 Imfinzi + treme (DANUBE) Lynparza + cediranib NME Bevespi - COPD (JP) Imfinzi + treme (KESTREL) Imfinzi + treme (POSEIDON) Imf
Slide 10: Approved medicines
AstraZeneca Approved medicines
Slide 11: Lynparza (PARP inhibitor) - Ovarian cancer
Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer Trial Population Patients Design Endpoints Status CVRM Phase III Platinum-sensitive recurrent 295 • Arm 1: Lynparza tablets 300mg BID as maintenance ther
Slide 12: Lynparza - Breast cancer and other cancers
Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Breast cancer and other cancers Trial Population Patients Design Endpoints Status CVRM Phase III BRCAm metastatic breast 302 • Arm 1: Lynparza 300mg BiD, continuous to
Slide 13: Tagrisso - Non-small cell lung cancer
Approved medicines Oncology Late-stage development Tagrisso (highly-selective, irreversible EGFRi) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Trial Population Patients Design Endpoints Status CVRM Phase III Advanced EGFRm NSCLC 410 • Arm 1: Tagrisso 80m
Slide 14: Tagrisso - Non-small cell lung cancer
Approved medicines Oncology Late-stage development Tagrisso (highly-selective, irreversible EGFRi) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Trial Population Patients Design Endpoints Status CVRM Phase Ib Advanced EGFRm TKI failure 308 • Arm 1: Tagriss
Slide 15: Imfinzi - Non-small cell lung cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Trial Population Patients Design Endpoints Status CVRM Phase III Adjuvant NSCLC patients 1,360 • Arm 1: Imfinzi mg/kg IV Q4W x 12m • Primar
Slide 16: Imfinzi - Other cancers
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune Other cancers Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 108 • Dose escalation: N=36, three cohorts receiving Treatment A • Safety and Toler
Slide 17: Imfinzi + tremelimumab - NSCLC and other cancers
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Non-small cell lung cancer (NSCLC) and other cancers CVRM Trial Population Patients Design Endpoints Status Phase III Stage IIIB-IV 3L NSCLC 480 •
Slide 18: Imfinzi + tremelimumab - Other cancers
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Other cancers CVRM Trial Population Patients Design Endpoints Status Phase II Urothelial Bladder Cancer 76 • Arm 1 tremelimumab urothelial bladder
Slide 19: Imfinzi + tremelimumab - Other cancers
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Other cancers CVRM Trial Population Patients Design Endpoints Status Phase III Advanced Solid Malignancies 1,200 • Arm 1: Imfinzi • Primary endpoi
Slide 20: Calquence - Blood cancers
Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development - IMED Early development - MedImmune Blood cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase III Previously untreated chronic 535 • Arm A: chlorambucil + obinutuzumab • Primary endpoin
Slide 21: Calquence - Blood cancers
Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development - IMED Early development - MedImmune 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 • Sa
Slide 22: Calquence - Blood cancers
Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development - IMED Early development - MedImmune Blood cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase I Japanese Adults with 28 • Calquence monotherapy • Safety • FPCD: Q2 2017 Advanced B-cell
Slide 23: Calquence - Other cancers
Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development - IMED Early development - MedImmune 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 H
Slide 24: Brilinta - Cardiovascular risk reduction
Approved medicines Oncology Late-stage development Brilinta (ADP receptor antagonist) Early development - IMED Early development - MedImmune Cardiovascular risk reduction Trial Population Patients Design Endpoints (primary) Status CVRM Phase III Patients with type-2 diabetes 19,000 • Arm 1: Brilinta
Slide 25: Farxiga - Diabetes
Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development - IMED Early development - MedImmune Diabetes Trial Population Patients Design Endpoints Status CVRM Phase III/IV Type-2 diabetes 17,160 • Arm 1: Farxiga 10mg QD + SoC therapy QD • Primary endpoints: Super
Slide 26: Farxiga - Diabetes / cardiovascular risk reduction
Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development - IMED Early development - MedImmune Diabetes / cardiovascular risk reduction Trial Population Patients Design Endpoints Status CVRM Phase III Patients With Chronic Heart 4,500 • Arm 1: Farxiga 10mg or 5 m
Slide 27: Qtern - Type-2 diabetes
Approved medicines Oncology Late-stage development Qtern (saxagliptin/dapagliflozin) (DPP-4/SGLT2 inhibitor) Early development - IMED Early development - MedImmune Type-2 diabetes Trial Population Patients Design Endpoints Status CVRM Phase III Type-2 diabetes 420 • Arm 1: saxagliptin 5mg + dapaglif
Slide 28: Bydureon - Type-2 diabetes
Approved medicines Oncology Late-stage development Bydureon (GLP-1 receptor agonist) Early development - IMED Early development - MedImmune Type-2 diabetes Trial Population Patients Design Endpoints Status CVRM Phase IV Type-2 diabetes 14,742 • Arm 1: Bydureon once weekly 2mg SC • Primary endpoint:
Slide 29: Lokelma - Hyperkalaemia
Approved medicines Oncology Late-stage development Lokelma (sodium zirconium cyclosilicate) Early development - IMED Early development - MedImmune Hyperkalaemia Trial Phase III Population Hyperkalaemia Patients 255 Design Open-label Lokelma 10g TID for 48 hours followed by: • Arm 1: Lokelma 5g QD fo
Slide 30: Lokelma - Hyperkalaemia
Approved medicines Oncology Late-stage development Lokelma (sodium zirconium cyclosilicate) Early development - IMED Early development - MedImmune Hyperkalaemia Trial Population Patients Design Endpoints Status CVRM Phase I Healthy Subjects 22 Arm 1: Open-label Lokelma 5g QD for 4 days • Primary end
Slide 31: Epanova - Hypertriglyceridaemia
Approved medicines Oncology Late-stage development Epanova (omega-3 carboxylic acids) Early development - IMED Early development - MedImmune Hypertriglyceridaemia Trial Population Patients Design Endpoints Status CVRM Phase III Patients with 13,000 • Arm 1: Epanova 4g QD + statin • Primary endpoint:
Slide 32: Eklira/Tudorza - COPD
Approved medicines Oncology Late-stage development Eklira/Tudorza (LAMA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase IV Patients with COPD 224 • Arm 1: Eklira/Tudorza 400μg DPI • Prim
Slide 33: Eklira/Tudorza - COPD
Approved medicines Oncology Late-stage development Eklira/Tudorza (LAMA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Trial Population Number of patients Design Endpoints Status CVRM Phase I Healthy Chinese 18 Open-label, 2-period ascending dose
Slide 34: Duaklir Genuair - COPD
Approved medicines Oncology Late-stage development Duaklir Genuair (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase IIb Patients with moderate COPD 120 • Arm 1: Duaklir Genuair
Slide 35: Duaklir Genuair - COPD
Approved medicines Oncology Late-stage development Duaklir Genuair (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase IIa Chinese patients with stable 20 • Single and multiple tw
Slide 36: Bevespi Aerosphere - COPD
Approved medicines Oncology Late-stage development Bevespi Aerosphere (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to very severe 2,103 Treatment (24-week Trea
Slide 37: Bevespi Aerosphere - COPD
Approved medicines Oncology Late-stage development Bevespi Aerosphere (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design (G = glycopyrronium, F = formoterol fumarate) Endpoints Status CVRM Phase III Moderat
Slide 38: Daliresp/Daxas - COPD
Approved medicines Oncology Late-stage development Daliresp/Daxas (oral PDE4 inhibitor) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase IV COPD 2,354 • 52W, randomised, DB with Daliresp 5
Slide 39: Fasenra - Severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe, uncontrolled asthma, 1,026 HD + ~200 MD • Arm 1: 30mg Q8w SC • Primary en
Slide 40: Fasenra - Severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Asthmatic with FEV1 (50-90% 200 • Arm 1: 30mg Q4W SC • Primary endpoint: Pulmonar
Slide 41: Fasenra - Severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe asthma 230 • Arm 1: 30mg Q4W SC • Primary endpoint: Onset and • FPCD: Q4 2
Slide 42: Fasenra - Nasal polyposis
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development - IMED Early development - MedImmune Nasal Polyposis Trial Population Patients Design Endpoints Status CVRM Phase III Patients with severe bilateral 400 • Arm 1: 30mg Q8W SC • Primary endpoint: Effect of Fasenra
Slide 43: Calquence - Rheumatoid arthritis
Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development - IMED Early development - MedImmune Rheumatoid arthritis Trial Population Patients Design Endpoint(s) Status CVRM Phase II Rheumatoid Arthritis 31 • Arm A: Calquence + methotrexate Disease Activity Score
Slide 44: Late-stage pipeline
AstraZeneca Late-stage pipeline
Slide 45: Moxetumomab pasudotox - Blood cancer
Approved medicines Oncology Late-stage development Moxetumomab pasudotox (CD22 mAb) Early development - IMED Early development - MedImmune Blood cancer Trial Population Patients Design Endpoints Status CVRM Phase III Adults with relapsed or 77 • Multicentre, single-arm, open-label Phase III trial •
Slide 46: Selumetinib - Thyroid cancer and other cancers
Approved medicines Oncology Late-stage development Selumetinib (MEK inhibitor) Early development - IMED Early development - MedImmune Thyroid cancer and other cancers Trial Population Patients Design Endpoints Status CVRM Phase III Differentiated thyroid cancer 233 • Arm 1: selumetinib 75mg BiD 5 we
Slide 47: Savolitinib - Papillary renal cell and other cancers
Approved medicines Oncology Late-stage development Savolitinib (MET inhibitor) Early development - IMED Early development - MedImmune Papillary renal cell and other cancers Trial Population Patients Design Endpoints Status CVRM Phase III MET-Driven, Papillary renal 180 • Arm 1: savolitinib 600mg QD
Slide 48: Cediranib - Ovarian cancer
Approved medicines Oncology Late-stage development Cediranib (VEGF receptor inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer Trial Population Patients Design Endpoints Status CVRM Phase IIb Platinum resistant recurrent 100 • Cediranib 30 mg + Lynparza 200 mg bd • ORR
Slide 49: Roxadustat - Anaemia
Approved medicines Oncology Late-stage development Roxadustat (HIF-PHI inhibitor) Early development - IMED Early development - MedImmune Anaemia Trial Population Patients Design Endpoints Status CVRM Phase III ANDES Anaemia in CKD (Chronic 922 • Arm 1: roxadustat Primary endpoint: Haemoglobin respon
Slide 50: Roxadustat - Anaemia
Approved medicines Oncology Late-stage development Roxadustat (HIF-PHI inhibitor) Early development - IMED Early development - MedImmune Anaemia Trial Population Patients Design Endpoints Status CVRM Phase III HIMALAYAS Anaemia in newly initiated 900 • Arm 1: roxadustat Primary endpoint: Haemoglobin
Slide 51: PT010 - COPD
Approved medicines Oncology Late-stage development PT010 (LAMA/LABA/ICS) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to very severe 500 Treatments (52-week Treatment Peri
Slide 52: Tezepelumab - Severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Tezepelumab (TSLP mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe asthma 1,060 • Arm 1: tezepelumab SC • Primary endpoint: Annual asthma
Slide 53: Anifrolumab - Lupus
Approved medicines Oncology Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Systemic lupus erythematosus (SLE) / Lupus nephritis (LN) Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to severe SLE 450 • Arm
Slide 54: Early development - IMED
AstraZeneca Early development - IMED (AstraZeneca Research and Early Development)
Slide 55: Adavosertib (AZD1775) - Cancer
Approved medicines Oncology Late-stage development Adavosertib (AZD1775, WEE-1 inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer, triple-negative breast cancer, small cell lung cancer (SCLC) Trial Population Patients Design Endpoints Status CVRM Phase II Platinum-resis
Slide 56: Adavosertib (AZD1775) - Cancer
Approved medicines Oncology Late-stage development Adavorsertib (AZD1775, WEE-1 inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer, triple-negative breast cancer, small cell lung cancer (SCLC) Trial Population Patients Design Endpoints Status CVRM Phase I Advanced solid
Slide 57: Capivasertib (AZD5363) - Cancer
Approved medicines Oncology Late-stage development Capivasertib (AZD5363, AKT inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Breast and gynaecological 12-24 per arm (Parts E AZD5363 400mg BD 4 days on 3 days off
Slide 58: Vistusertib (AZD2014) - Cancer
Approved medicines Oncology Late-stage development Vistusertib (AZD2014, mTORC1/2 inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase II 2L oestrogen-receptor positive 316 • Arm 1: Faslodex • Primary endpoint: PFS • FP
Slide 59: AZD0156 - Cancer
Approved medicines Oncology Late-stage development AZD0156 (ATM inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 130 • Arm 1: AZD0156 + Lynparza • Safety, tolerability, PK and efficacy • FPCD: Q4 201
Slide 60: AZD1390 - Cancer
Approved medicines Oncology Late-stage development AZD1390 (ATM inhibitor, blood brain barrier) Early development - IMED Early development - MedImmune Cancer Trial Population Subjects Design Endpoints Status CVRM Phase I Healthy Volunteers 8 • Positron-Emission Tomography (PET) trial • Brain distrib
Slide 61: AZD2811 - Cancer
Approved medicines Oncology Late-stage development AZD2811 (AURN) Early development - IMED Early development - MedImmune 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
Slide 62: AZD4547 - Cancer
Approved medicines Oncology Late-stage development AZD4547 (FGFR inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase II Female ER+ breast cancer 40 • Part A: AZD4547 in ascending multiple doses in combination • Part A:
Slide 63: AZD4573 - Cancer
Approved medicines Oncology Late-stage development AZD4573 (CDK9 inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/refractory 42 Dose Escalation in relapsed/refractory haematological • Primary-Safety/PK; s
Slide 64: AZD4635 - Cancer
Approved medicines Oncology Late-stage development AZD4635 (A2AR inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Phase Ia: patients with 38 • Phase Ia: dose escalation to determine the MTD of AZD4635 Primary Outc
Slide 65: AZD4785 - Cancer
Approved medicines Oncology Late-stage development AZD4785 (KRAS antisense oligonucleotide) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Phase Ia: patients with 30 (estimated) • Phase Ia: dose escalation to determine the
Slide 66: AZD5069 - Cancer
Approved medicines Oncology Late-stage development AZD5069 (CXCR2 antagonist) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase Ib/II Head and neck squamous-cell 465 Dose Escalation advanced solid and blood cancers • Safety/Eff
Slide 67: AZD5153 - Cancer
Approved medicines Oncology Late-stage development AZD5153 (BRD4 inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I/Ib Relapsed/refractory solid 54 Dose Escalation advanced solid and lymphomas • Primary-Safety/ seco
Slide 68: AZD5991 - Cancer
Approved medicines Oncology Late-stage development AZD5991 (MCL1 inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/refractory 48 Dose Escalation in relapsed/refractory haematological • Primary-Safety/ seco
Slide 69: AZD6738 - Cancer
Approved medicines Oncology Late-stage development AZD6738 (ATR inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 160 • Arm 1: AZD6738 + carboplatin • Safety and tolerability • FPCD: Q4 2014 • Arm 2:
Slide 70: AZD8186 - Cancer
Approved medicines Oncology Late-stage development AZD8186 (PI3Kb/d inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced Castrate Resistant 153 • Part A: AZD8186 monotherapy in ascending intermittent doses •
Slide 71: AZD9150 - Cancer
Approved medicines Oncology Late-stage development AZD9150 (STAT3 inhibitor) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase Ib/II Head and neck squamous-cell 405 Dose Escalation advanced solid and blood cancers • Safety/Effi
Slide 72: AZD9496 - Breast cancer
Approved medicines Oncology Late-stage development AZD9496 (selective estrogen receptor degrader) Early development - IMED Early development - MedImmune Breast cancer Trial Population Patients Design Endpoints Status CVRM Phase I ER+ Breast Cancer ~50 • This is an open label randomised multicentre p
Slide 73: Verinurad - Chronic kidney disease
Approved medicines Oncology Late-stage development Verinurad (RDEA3170, URAT1 inhibitor) Early development - IMED Early development - MedImmune Chronic kidney disease Trial Population Patients Design Endpoints Status CVRM Phase II CKD (Chronic Kidney 60 • Arm A: verinurad 9 mg and febuxostat 80 mg T
Slide 74: AZD4831 & AZD5718 - Cardiovascular disease
Approved medicines Oncology Late-stage development AZD4831 (MPO inhibitor) & AZD5718 (FLAP inhibitor) Early development - IMED Early development - MedImmune Cardiovascular disease Trial Population Patients Design Endpoints Status CVRM AZD4831 (MPO) Healthy subjects ~96 SAD trial (one trial site in G
Slide 75: AZD8601 - Cardiovascular disease
Approved medicines Oncology Late-stage development AZD8601 (VEGF-A modified RNA) Early development - IMED Early development - MedImmune Cardiovascular disease Trial Population Patients Design Endpoints Status CVRM Phase I Type 2 diabetic patients ~60 SAD trial (one trial site in Germany) • Safety an
Slide 76: AZD9977 - Heart failure
Approved medicines Oncology Late-stage development AZD9977 Early development - IMED Early development - MedImmune 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 •
Slide 77: AZD0548 (abediterol) - Asthma
Approved medicines Oncology Late-stage development AZD0548 (abediterol, LABA) Early development - IMED Early development - MedImmune Asthma Trial Population Patients Design Endpoints Status CVRM Phase I Patients With Asthma on 12 A randomised, single-blind, placebo-controlled study to assess • To as
Slide 78: AZD1402 - Asthma
Approved medicines Oncology Late-stage development AZD1402 (IL4 Receptor antagonist) Early development - IMED Early development - MedImmune Asthma Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects Inhaled: 56 SAD. Primary Endpoint • FPCD: Q4 2017 A Dose Escalating Singl
Slide 79: AZD1419 - Asthma
Approved medicines Oncology Late-stage development AZD1419 (TLR9 agonist) Early development - IMED Early development - MedImmune 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 los
Slide 80: AZD5634 - Cystic fibrosis
Approved medicines Oncology Late-stage development AZD5634 (epithelial NaC inhibitor) Early development - IMED Early development - MedImmune Cystic fibrosis Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects Part A: 57 SAD. Primary Endpoint • FPCD: Q1 2016 Part B: 6 A Ph
Slide 81: AZD7594 - Asthma/COPD
Approved medicines Oncology Late-stage development AZD7594 (inhaled SGRM) Early development - IMED Early development - MedImmune Asthma/chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase II Patients with mild to moderate 48 A randomised, double
Slide 82: AZD7594 - Asthma/COPD
Approved medicines Oncology Late-stage development AZD7594 (inhaled SGRM) Early development - IMED Early development - MedImmune Asthma/chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 18 A randomised open label three-way cr
Slide 83: AZD8871 - COPD
Approved medicines Oncology Late-stage development AZD8871 (MABA2) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase IIa Moderate to severe COPD 42 Comprises 3 treatment periods of 14 days
Slide 84: AZD9567 - Respiratory
Approved medicines Oncology Late-stage development AZD9567 (oSGRM) Early development - IMED Early development - MedImmune 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:
Slide 85: AZD0284 - Plaque psoriasis vulgaris
Approved medicines Oncology Late-stage development AZD0284 (RORγ inverse agonist) Early development - IMED Early development - MedImmune Plaque psoriasis vulgaris Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 80 Part 1 (SAD) • Safety and tolerability and PK followin
Slide 86: Early development - MedImmune
MedImmune Early development - MedImmune Research & Early Development
Slide 87: Imfinzi - Cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune 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
Slide 88: Imfinzi + tremelimumab - Cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase Ib/II Gastric/gastro-Oesophageal 135 • Arm A: Imfinzi + tremelimumab 2L • Prim
Slide 89: Imfinzi + Iressa - NSCLC
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + Iressa (gefitinib) Non-small cell lung cancer (NSCLC) CVRM Trial Population Patients Design Endpoints Status Phase I NSCLC 56 Escalation phase Primary endpoints: • FPCD: Q2
Slide 90: Imfinzi + MEDI0680 - Cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + MEDI0680 (PD-1 mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase I Advanced malignancies 96 Dose-escalation phase Primary endpoints: • FPCD: Q2 2014
Slide 91: Imfinzi + dabrafenib / trametinib - Melanoma
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) + dabrafenib Early development - IMED Early development - MedImmune (BRAF inhibitor) / trametinib (MEK inhibitor) Melanoma CVRM Trial Population Patients Design Endpoints Status Phase I/II Metastatic or unresectable 68 Dose Escal
Slide 92: Oleclumab (MEDI9447) - Cancer
Approved medicines Oncology Late-stage development Oleclumab (MEDI9447, CD73 mAb) Early development - IMED Early development - MedImmune Cancer CVRM Trial Population Patients Design Endpoints Status Phase I Advanced malignancies 188 Dose-escalation phase Primary endpoints: • FPCD: Q3 2015 • olecluma
Slide 93: Imfinzi + monalizumab - Cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + monalizumab (NKG2a mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase I Advanced solid tumours 262 Escalation phase Primary endpoints: • FPCD: Q2 2016
Slide 94: MEDI0457 + Imfinzi - SCCHN
Approved medicines Oncology Late-stage development MEDI0457 Early development - IMED Early development - MedImmune + Imfinzi (PD-L1 mAb) Squamous cell carcinoma of the Head and Neck (SCCHN) CVRM Trial Population Patients Design Endpoints Status Phase Ib/IIa Human papillomavirus (HPV) 40 Multi-centre
Slide 95: MEDI0562 (OX40 mAb) - Cancer
Approved medicines Oncology Late-stage development MEDI0562 (OX40 mAb) Early development - IMED Early development - MedImmune MEDI0562 (OX40 mAb) + Imfinzi (PD-L1 mAb) or tremelimumab (CTLA-4 mAb) CVRM Cancer Trial Population Patients Design Endpoints Status Respiratory Phase I Advanced malignancies
Slide 96: MEDI1873 (GITR agonist) - Cancer
Approved medicines Oncology Late-stage development MEDI1873 (GITR agonist) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Adult subjects with select 40 Dose-escalation phase Primary endpoints: • FPCD: Q4 2015 advanced soli
Slide 97: MEDI2228 - Cancer
Approved medicines Oncology Late-stage development MEDI2228 Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/Refractory Multiple 129 First-time-in-human Phase 1, multi-centre, open-label, single-arm, Primary endpoin
Slide 98: MEDI3726 - Cancer
Approved medicines Oncology Late-stage development MEDI3726 (PSMA antibody drug conjugate) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I/Ib Subjects with metastatic 224 Open-label, Dose-escalation and Dose-expansion Prima
Slide 99: MEDI4276 (HER2 ADC) - Cancer
Approved medicines Oncology Late-stage development MEDI4276 (HER2 ADC) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced HER2+ metastatic 47 • First-time-in-human Phase 1, multi-centre, open-label, single- • Primary
Slide 100: MEDI5083 + Imfinzi - Cancer
Approved medicines Oncology Late-stage development MEDI5083 + Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced Solid Tumours 204 Dose-escalation phase Primary endpoints: • FPCD: Q1 2017 • Part 1:
Slide 101: MEDI5752 - Cancer
Approved medicines Oncology Late-stage development MEDI5752 Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced solid tumour 309 Open-label, Dose-escalation and Dose-expansion Primary endpoints: • FPCD: Q2 2018 • Dose-
Slide 102: MEDI7247 - Cancer
Approved medicines Oncology Late-stage development MEDI7247 (PBD ADC mAb) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/Refractory 228 First-time-in-human Phase 1, multi-centre, open-label, single-arm, • Primary
Slide 103: MEDI9197 - Cancer
Approved medicines Oncology Late-stage development MEDI9197 (TLR7/8 agonist) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced solid tumour 135 Dose-escalation phase Primary endpoints: • FPCD: Q4 2015 malignancies re
Slide 104: MEDI0382 - Diabetes
Approved medicines Oncology Late-stage development MEDI0382 (GLP-1-glucagon agonist) Early development - IMED Early development - MedImmune Diabetes Trial Population Patients Design Endpoints Status CVRM Phase I Healthy adult subjects 64 • SAD SC administration • Safety profile in terms of adverse e
Slide 105: MEDI0382 - Diabetes
Approved medicines Oncology Late-stage development MEDI0382 (GLP-1-glucagon agonist) Early development - IMED Early development - MedImmune Diabetes Trial Population Patients Design Endpoints Status CVRM Phase I Healthy adult subjects 22 • Open label, one sequence, cross-over • Effect of MEDI0382 on
Slide 106: MEDI7219 - Diabetes
Approved medicines Oncology Late-stage development MEDI7219 Early development - IMED Early development - MedImmune Diabetes Trial Population Patients Design Endpoints Status CVRM Phase I Healthy Volunteers 126 • 4 part study • Safety and tolerability • FPCD: Q1 2018 • Part A : SAD • Pharmacokinetics
Slide 107: Biologics - Cardiovascular & metabolic diseases
Approved medicines Oncology Late-stage development Biologics Early development - IMED Early development - MedImmune Cardiovascular & metabolic diseases Trial Compound Population Patients Design Endpoints Status CVRM Phase IIa rhLCAT Adults with stable 56 • SAD in stable CAD patients • Safety profile
Slide 108: MEDI3506 - COPD
Approved medicines Oncology Late-stage development MEDI3506 (IL-33 mAb) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase I (Combined SAD / SAD: Healthy subjects with SAD: 56 SAD: • Safety
Slide 109: Prezalumab (MEDI5872) - SLE
Approved medicines Oncology Late-stage development Prezalumab (MEDI5872, B7RP-1 mAb) Early development - IMED Early development - MedImmune Systemic lupus erythematosus (SLE) Trial Population Patients Design Endpoints Status CVRM Phase IIa Primary Sjögren's syndrome 42 • Arm 1: MEDI5872 210mg SC QW
Slide 110: MEDI0700 - SLE
Approved medicines Oncology Late-stage development MEDI0700 - AMG 570 (Anti-B7RP-1 mAb/BAFF) Early development - IMED Early development - MedImmune Systemic lupus erythematosus (SLE) Trial Population Patients Design Endpoints Status CVRM Phase Ia Healthy subjects 48 Single Ascending Dose • Safety an
Slide 111: MEDI1341 - Parkinson's disease
Approved medicines Oncology Late-stage development MEDI1341 (alpha-synuclein mAb) Early development - IMED Early development - MedImmune Parkinson’s Disease Trial Population Patients Design Endpoints Status CVRM Phase I Healthy volunteers 40 • SAD • Safety, tolerability, PK, PD • FPCD: Q4 2017 • Up
Slide 112: MEDI1814 - Alzheimer's disease
Approved medicines Oncology Late-stage development MEDI1814 (amyloid beta mAb) Early development - IMED Early development - MedImmune Alzheimer’s disease Trial Population Patients Design Endpoints Status CVRM Phase I Alzheimer’s disease & healthy 121 • SAD & MAD • Safety, tolerability • FPCD: Q2 201
Slide 113: MEDI7352 - Osteoarthritis pain
Approved medicines Oncology Late-stage development MEDI7352 (NGF TNF bispecific mAb) Early development - IMED Early development - MedImmune Osteoarthritis pain Trial Population Patients Design Endpoints Status CVRM Phase I Painful osteoarthritis of the knee 160 • SAD & MAD • Safety, tolerability, PK
Slide 114: Other biologics - Infections
Approved medicines Oncology Late-stage development Other biologics Early development - IMED Early development - MedImmune Infections Trial Compound Population Patients Design Endpoints Status CVRM Phase II Anti-Staph AT Intubated Intensive 213 • Placebo-controlled, single-dose, dose-ranging • Effica
Slide 115: Clinical Trials Appendix Q2 2018 results update
Clinical Trials Appendix Q2 2018 results update