Astrazeneca Plc · LSE:AZN

Astrazeneca — Q2 2018 Earnings Presentation

115 slides from Astrazeneca's earnings presentation, 2018

  1. Slide 1: Clinical Trials Appendix Q2 2018 results update

    Clinical Trials Appendix Q2 2018 results update

  2. 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

  3. 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

  4. 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 -

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Slide 10: Approved medicines

    AstraZeneca Approved medicines

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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 •

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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:

  29. 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

  30. 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

  31. 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:

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. Slide 44: Late-stage pipeline

    AstraZeneca Late-stage pipeline

  45. 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 •

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. Slide 54: Early development - IMED

    AstraZeneca Early development - IMED (AstraZeneca Research and Early Development)

  55. 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

  56. 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

  57. 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

  58. 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

  59. 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

  60. 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

  61. 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

  62. 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:

  63. 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

  64. 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

  65. 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

  66. 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

  67. 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

  68. 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

  69. 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:

  70. 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 •

  71. 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

  72. 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

  73. 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

  74. 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

  75. 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

  76. 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 •

  77. 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

  78. 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

  79. 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

  80. 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

  81. 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

  82. 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

  83. 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

  84. 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:

  85. 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

  86. Slide 86: Early development - MedImmune

    MedImmune Early development - MedImmune Research & Early Development

  87. 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

  88. 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

  89. 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

  90. 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

  91. 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

  92. 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

  93. 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

  94. 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

  95. 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

  96. 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

  97. 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

  98. 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

  99. 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

  100. 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:

  101. 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-

  102. 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

  103. 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

  104. 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

  105. 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

  106. 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

  107. 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

  108. 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

  109. 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

  110. 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

  111. 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

  112. 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

  113. 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

  114. 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

  115. Slide 115: Clinical Trials Appendix Q2 2018 results update

    Clinical Trials Appendix Q2 2018 results update

AstraZeneca — Q2 2018 Earnings Presentation on 6ix