Astrazeneca Plc · LSE:AZN

Astrazeneca — Q3 2017 Earnings Presentation

111 slides from Astrazeneca's earnings presentation, 2017

  1. Slide 1: Clinical trials appendix: Year-to-date and Q3 2017 Results update

    Clinical trials appendix Year-to-date and Q3 2017 Results update

  2. Slide 2: Information about AstraZeneca clinical trials in Phases I-IV

    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 September 201

  3. Slide 3: List of abbreviations

    List of abbreviations AE Adverse Event LCM Lifecycle Management PD Pharmacodynamcis AUC Area Under Curve LPCD Last Patient Commenced Dosing Q2W Quaque (every) Two Weeks BID Bis In Die (two times a day) MAD Multiple Ascending Dose Q3W Quaque (every) Three Weeks CE Clinically Evaluable MDI Metered-Dos

  4. Slide 4: Table of contents

    Table of contents slide Early development - IMED (AstraZeneca Research & Early Development) Movement since H1 2017 results announcement Oncology Year-to-date and Q3 2017 New Molecular Entity (NME) pipeline CVMD Year-to-date and Q3 2017 Lifecycle Management (LCM) pipeline Respiratory Other Approved m

  5. Slide 5: Movement since Q2 2017 update

    Movement since Q2 2017 update New to Phase I New to Phase II New to Pivotal Study New to Registration Additional indications Additional indications NME NME Imfinzi# + azacitidine Lynparza + Imfinzi MEDIOLA savolitinib# SAVOIR Calquence# (acalabrutinib#) [US]1 PD-L1 mAb + azacytidine myelodysplastic

  6. Slide 6: Q3 2017 New Molecular Entity (NME) Pipeline

    Q3 2017 New Molecular Entity (NME)1 Pipeline 1 Includes significant fixed-dose combination projects and parallel indications that are in a separate therapy area (See LCM chart for other parallel indications and oncology combination projects) # Partnered and/or in collaboration; ¶ Registrational P2/3

  7. Slide 7: Q3 2017 Lifecycle Management (LCM) Pipeline

    Q3 2017 Lifecycle Management (LCM)1 Pipeline 1 Includes significant LCM projects and parallel indications for assets in P3 or beyond. Excludes LCM projects already launched in a major market # Partnered and/or in collaboration; ¶ Registrational P2/3 study Oncology Cardiovascular and Metabolic Diseas

  8. Slide 8: Q3 2017 Lifecycle Management (LCM) Pipeline

    Q3 2017 Lifecycle Management (LCM)1 Pipeline 1 Includes significant LCM projects and parallel indications for assets in P3 or beyond. Excludes LCM projects already launched in a major market # Partnered and/or in collaboration; ¶ Registrational P2/3 study Oncology Cardiovascular and Metabolic Diseas

  9. Slide 9: Approved medicines

    AstraZeneca Approved medicines

  10. Slide 10: Lynparza: ovarian cancer and other cancers

    Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer and other cancers Trial Population Patients Design Endpoints Status CVMD Phase III Platinum-sensitive recurrent 295 • Arm 1: Lynparza tablets 300mg BiD a

  11. Slide 11: 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 CVMD Phase III BRCAm metastatic breast 302 • Arm 1: Lynparza 300mg BiD, continuous to

  12. Slide 12: 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) CVMD Trial Population Patients Design Endpoints Status Phase III Advanced EGFRm NSCLC 410 • Arm 1: Tagrisso 80m

  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) CVMD Trial Population Patients Design Endpoints Status Phase Ib Advanced EGFRm NSCLC ~90 • Arm 1: Tagrisso + Im

  14. Slide 14: 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 CVMD Phase III Adjuvant NSCLC patients 1,100 • Arm 1: Imfinzi mg/kg IV Q4W x 12m • Primar

  15. Slide 15: Imfinzi: other cancers

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune Other cancers CVMD Trial Population Patients Design Endpoints Status Phase I Solid tumours 108 • Dose Escalation: N=36, three cohorts receiving Treatment A • Safety and Toler

  16. Slide 16: 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 CVMD Trial Population Patients Design Endpoints Status Phase III Stage IIIB-IV 3L NSCLC 480 •

  17. Slide 17: 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 CVMD Trial Population Patients Design Endpoints Status Phase III Advanced Solid Malignancies 1,200 • Arm 1: Imfinzi • Primary endpoi

  18. Slide 18: Calquence: blood cancers

    Approved medicines Oncology Late-stage development Calquence (acalabrutinib, BTK inhibitor) Early development - IMED Early development - MedImmune Blood cancers Trial Population Patients Design Endpoint(s) Status CVMD Phase III Relapsed/refractory chronic 500 • Arm A: Calquence • Primary endpoint: P

  19. Slide 19: Calquence: blood cancers

    Approved medicines Oncology Late-stage development Calquence (acalabrutinib, BTK inhibitor) Early development - IMED Early development - MedImmune Blood cancers Trial Population Patients Design Endpoint(s) Status CVMD Phase I/II B-Cell Malignancies 126 Dose escalation and expansion trial of the comb

  20. Slide 20: Calquence: blood cancers

    Approved medicines Oncology Late-stage development Calquence (acalabrutinib, BTK inhibitor) Early development - IMED Early development - MedImmune Blood cancers Trial Population Patients Design Endpoint(s) Status CVMD Phase I Japanese Adults with 28 • Calquence monotherapy • Safety • FPCD: Q2 2017 A

  21. Slide 21: Calquence: other cancers

    Approved medicines Oncology Late-stage development Calquence (acalabrutinib, BTK inhibitor) Early development - IMED Early development - MedImmune Other cancers Trial Population Patients Design Endpoint(s) Status CVMD Phase II ≥ 2L advanced or metastatic 74 • Arm A: pembrolizumab • ORR • FPCD: Q2 20

  22. Slide 22: 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 CVMD Phase III Patients with type-2 diabetes 19,000 • Arm 1: Brilinta

  23. Slide 23: Farxiga: diabetes

    Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development - IMED Early development - MedImmune Diabetes Trial Population Patients Design Endpoints Status CVMD Phase III/IV Type-2 diabetes 17,276 • Arm 1: Farxiga 10mg QD + SoC therapy QD • Primary endpoint: Time t

  24. Slide 24: 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 CVMD Phase III Patients With Chronic Heart 4,500 • Arm 1: Farxiga 10mg or 5 m

  25. Slide 25: 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 CVMD Phase III Type-2 diabetes 420 • Arm 1: saxagliptin 5mg + dapaglif

  26. Slide 26: 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 CVMD Phase IV Type-2 diabetes 14,742 • Arm 1: Bydureon once weekly 2mg SC • Primary endpoint:

  27. Slide 27: 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 CVMD Phase III Patients with hypertri- 13,000 • Arm 1: Epanova 4g QD + statin • Primary

  28. Slide 28: Symbicort: mild asthma

    Approved medicines Oncology Late-stage development Symbicort (ICS/LABA) Early development - IMED Early development - MedImmune Mild asthma Trial Population Patients Design Endpoints Status CVMD Phase III Patients in need of GINA 3,850 • Arm 1: Symbicort Turbuhaler 160/4.5 μg 'as needed' + Placebo •

  29. Slide 29: 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 CVMD Phase IV Patients with COPD 224 • Arm 1: Eklira/Tudorza 400μg • Primary

  30. Slide 30: 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 CVMD Phase IIb Patients with moderate COPD 120 • Arm 1: Duaklir Genuair

  31. Slide 31: 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 CVMD Phase IIa Chinese patients with stable 20 • Single and multiple tw

  32. Slide 32: 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 CVMD Phase III Moderate to very severe 2,103 Treatment (24-week Trea

  33. Slide 33: 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 CVMD Phase III Moderat

  34. Slide 34: 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 CVMD Phase IV COPD 2,354 • 52W, randomised, DB with Daliresp 5

  35. Slide 35: Calquence: rheumatoid arthritis

    Approved medicines Oncology Late-stage development Calquence (acalabrutinib) Early development - IMED Early development - MedImmune Rheumatoid arthritis Trial Population Patients Design Endpoint(s) Status CVMD Phase II Rheumatoid Arthritis 31 • Arm A: Calquence + methotrexate Disease Activity Score

  36. Slide 36: Late-stage pipeline

    AstraZeneca Late-stage pipeline

  37. Slide 37: 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 CVMD Phase III Adults with relapsed or 77 • Multicentre, single-arm, open-label Phase III trial •

  38. Slide 38: 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 CVMD Phase III Differentiated thyroid cancer 304 • Arm 1: selumetinib 75mg BiD 5 we

  39. Slide 39: Savolitinib: papillary renal cell and other cancers

    Approved medicines Oncology Late-stage development Savolitinib (MET) Early development - IMED Early development - MedImmune Papillary renal cell and other cancers Trial Population Patients Design Endpoints Status CVMD Phase III MET-Driven, Papillary renal 180 • Arm 1: savolitinb 600mg QD • Primary e

  40. Slide 40: Cediranib: ovarian cancer

    Approved medicines Oncology Late-stage development Cediranib (VEGF-inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer Trial Population Patients Design Endpoints Status CVMD Phase IIb Platinum resistant recurrent 100 • Cediranib 30 mg + Lynparza 200 mg bd • ORR DoR, DCR,

  41. Slide 41: ZS-9: hyperkalaemia

    Approved medicines Oncology Late-stage development ZS-9 (Sodium zirconium cyclosilicate) Early development - IMED Early development - MedImmune Hyperkalaemia Trial Phase II Population Hyperkalaemia and moderate chronic kidney disease (CKD) Patients 90 Design • Arm 1: Escalating TID doses (0.3g, 3g a

  42. Slide 42: Roxadustat: anaemia

    Approved medicines Oncology Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Anaemia Trial Population Patients Design Endpoints Status CVMD Phase III ANDES Anaemia in CKD patients not 900 • Arm 1: roxadustat Primary endpoint: Haemoglobin response • F

  43. Slide 43: Roxadustat: anaemia

    Approved medicines Oncology Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Anaemia Trial Population Patients Design Endpoints Status CVMD Phase III HIMALAYAS Anaemia in newly initiated 750 • Arm 1: roxadustat Primary endpoint: Haemoglobin response

  44. Slide 44: Benralizumab: severe, uncontrolled asthma

    Approved medicines Oncology Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVMD Phase III Severe, uncontrolled asthma, 1,026 HD + ~200 MD • Arm 1: 30mg Q8w SC • Prima

  45. Slide 45: Benralizumab: severe, uncontrolled asthma

    Approved medicines Oncology Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVMD Phase III Asthmatic with FEV1 (50-90% 200 • Arm 1: 30mg Q4W SC • Primary endpoint: Pul

  46. Slide 46: Benralizumab: severe, uncontrolled asthma

    Approved medicines Oncology Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVMD Phase III Severe asthma 230 • Arm 1: 30mg Q4W SC • Primary endpoint: Onset and • FPCD:

  47. Slide 47: Benralizumab: COPD

    Approved medicines Oncology Late-stage development Benralizumab (IL-5R mAb) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase III Moderate to very severe 2,168 • Arm 1: 10mg Q8W SC • Primar

  48. Slide 48: Tralokinumab: severe, uncontrolled asthma

    Approved medicines Oncology Late-stage development Tralokinumab (IL-13 mAb) Early development - IMED Early development - MedImmune Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVMD Phase III Adults with severe, 1,207 Cohort 1: • Primary endpoint: Asthma exacerbation

  49. Slide 49: PT010: COPD and asthma

    Approved medicines Oncology Late-stage development PT010 (LAMA/LABA/ICS) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) & asthma Trial Population Patients Design Endpoints Status CVMD Phase III Moderate to very severe 500 Treatments (52-week Treat

  50. Slide 50: PT010: COPD and asthma

    Approved medicines Oncology Late-stage development PT010 (LAMA/LABA/ICS) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) & asthma Trial Population Patients Design Endpoints Status CVMD Phase II Adult mild to moderate 150 • Arm 1: BD MDI 320μg BiD •

  51. Slide 51: PT010: COPD and asthma

    Approved medicines Oncology Late-stage development PT010 (LAMA/LABA/ICS) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) & asthma Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 60 • Arm 1: BGF MDI 320/14.4/9.6μg • O

  52. Slide 52: Anifrolumab: SLE / lupus nephritis

    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 CVMD Phase III Moderate to severe SLE 450 • Arm

  53. Slide 53: Lanabecestat: Alzheimer's disease

    Approved medicines Oncology Late-stage development Lanabecestat (BACE inhibitor) Early development - IMED Early development - MedImmune Alzheimer’s disease Trial Population Patients Design Endpoints Status CVMD Phase III Early Alzheimer’s disease 2,216 • Arm 1: lanabecestat 20mg once daily • Primary

  54. Slide 54: Early development - IMED

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

  55. Slide 55: AZD0156 (ATM): cancer

    Approved medicines Oncology Late-stage development AZD0156 (ATM) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Solid tumours 130 • Arm 1: AZD0156 + Lynparza • Safety, tolerability, PK and efficacy • FPCD: Q4 2015 • Arm 2:

  56. Slide 56: AZD1775 (WEE-1): ovarian, breast and lung cancer

    Approved medicines Oncology Late-stage development AZD1775 (WEE-1) Early development - IMED Early development - MedImmune Ovarian cancer, triple-negative breast cancer, small cell lung cancer (SCLC) Trial Population Patients Design Endpoints Status CVMD Phase II Platinum-resistant (PR) 97 • Arm B: p

  57. Slide 57: Vistusertib (AZD2014): breast and NSCLC

    Approved medicines Oncology Late-stage development Vistusertib (AZD2014) (TORC 1/2) Early development - IMED Early development - MedImmune Breast and squamous non-small cell lung cancer (NSCLC) Trial Population Patients Design Endpoints Status CVMD Phase II 2L oestrogen-receptor positive 316 • Arm 1

  58. Slide 58: AZD2811 (AURN): cancer

    Approved medicines Oncology Late-stage development AZD2811 (AURN) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Solid tumours 72 • Arm 1: AZD2811 dose escalation • Safety and tolerability • FPCD: Q4 2015 • Arm 2: AZD2811

  59. Slide 59: AZD4547 (FGFR): cancer

    Approved medicines Oncology Late-stage development AZD4547 (FGFR) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase II Female ER+ breast cancer 40 • Part A: AZD4547 in ascending multiple doses in combination • Part A: MTD of AZ

  60. Slide 60: AZD4573 (CDK9): cancer

    Approved medicines Oncology Late-stage development AZD4573 (CDK9) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Relapsed/refractory 42 Dose Escalation in relapsed/refractory haematological • Primary-Safety/PK; secondary-e

  61. Slide 61: AZD4635 (A2AR): cancer

    Approved medicines Oncology Late-stage development AZD4635 (A2AR) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Phase Ia: patients with 36 (estimated) • Phase 1a: dose escalation to determine the Maximum Primary Outcome M

  62. Slide 62: AZD4785 (KRAS antisense oligonucleotide): cancer

    Approved medicines Oncology Late-stage development AZD4785 (KRAS antisense oligonucleotide) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Phase Ia: patients with 30 (estimated) • Phase Ia: dose escalation to determine the

  63. Slide 63: AZD5069 (CXCR2): cancer

    Approved medicines Oncology Late-stage development AZD5069 (CXCR2) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase Ib/II Squamous Cell Carcinoma of 405 Dose Escalation advanced solid and blood cancers • Safety/Efficacy trial

  64. Slide 64: AZD5153 (BRD4): cancer

    Approved medicines Oncology Late-stage development AZD5153 (BRD4) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I/Ib Relapsed/refractory solid 54 Dose Escalation advanced solid and lymphomas • Primary-Safety/ secondary-Effi

  65. Slide 65: AZD5363 (AKT): cancer

    Approved medicines Oncology Late-stage development AZD5363 (AKT) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase IIb ER+ breast cancer receiving 100 • Arm 1: AZD5363 + paclitaxel • PFS • FPCD: Q1 2014 st 1 treatment with pacl

  66. Slide 66: AZD5991 (MCL1): cancer

    Approved medicines Oncology Late-stage development AZD5991 (MCL1) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Relapsed/refractory 30 Dose Escalation in relapsed/refractory haematological • Primary-Safety/ secondary-Effi

  67. Slide 67: AZD6738 (ATR): cancer

    Approved medicines Oncology Late-stage development AZD6738 (ATR) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Solid tumours 160 • Arm 1: AZD6738 + carboplatin • Safety and tolerability • FPCD: Q4 2014 • Arm 2: AZD6738 do

  68. Slide 68: AZD8186 (PI3Kb/d): cancer

    Approved medicines Oncology Late-stage development AZD8186 (PI3Kb/d) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Advanced Castrate Resistant 153 • Part A: AZD8186 monotherapy in ascending intermittent doses • Part A: PK

  69. Slide 69: AZD9150 (STAT3): cancer

    Approved medicines Oncology Late-stage development AZD9150 (STAT3) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase Ib/II Squamous Cell Carcinoma of 405 Dose Escalation advanced solid and blood cancers • Safety/Efficacy trial

  70. Slide 70: AZD9496 (SERD): breast cancer

    Approved medicines Oncology Late-stage development AZD9496 (SERD) Early development - IMED Early development - MedImmune Breast cancer Trial Population Patients Design Endpoints Status CVMD Phase I ER+ Breast Cancer ~50 • This is an open label randomised multicentre pre-surgical • Primary Outcome Me

  71. Slide 71: AZD4831, AZD5718, AZD8601: cardiovascular disease

    Approved medicines Oncology Late-stage development AZD4831, AZD5718, AZD8601 Early development - IMED Early development - MedImmune Cardiovascular disease Trial Population Patients Design Endpoints Status CVMD AZD4831 (MPO) Healthy subjects ~96 SAD trial (one trial site in Germany) • Safety and tole

  72. Slide 72: AZD8601 (VEGF-A): cardiovascular disease

    Approved medicines Oncology Late-stage development AZD8601 (VEGF-A) Early development - IMED Early development - MedImmune Cardiovascular disease Trial Population Patients Design Endpoints Status CVMD Phase I Type 2 diabetic patients ~60 SAD trial (one trial site in Germany) • Safety and tolerabilit

  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 CVMD Phase II CKD patients with 60 • Arm A: verinurad 9 mg and febuxostat 80 mg To

  74. Slide 74: Abediterol (AZD0548, LABA): asthma

    Approved medicines Oncology Late-stage development Abediterol (AZD0548, LABA) Early development - IMED Early development - MedImmune Asthma Trial Population Patients Design Endpoints Status CVMD Phase II Patients With Asthma on 36 Single-dose 6-way cross-over to investigate ultra-low doses of Primar

  75. Slide 75: AZD1419 (TLR9 agonist): asthma

    Approved medicines Oncology Late-stage development AZD1419 (TLR9 agonist) Early development - IMED Early development - MedImmune Asthma Trial Population Patients Design Endpoints Status CVMD Phase IIa Adults with eosinophilic, 81 • Arm 1: AZD1419, once-weekly adaptive dosing (4mg, 1mg, • Time to los

  76. Slide 76: 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 CVMD Phase I Healthy subjects Part A: 57 SAD. Primary Endpoint • FPCD: Q1 2016 Part B: 6 A Ph

  77. Slide 77: AZD7594 (inhaled SGRM): 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 CVMD Phase II Patients with mild to moderate 48 A randomised, double

  78. Slide 78: AZD7594 (inhaled SGRM): 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 CVMD Phase I Healthy subjects 18 A randomised open label three-way cr

  79. Slide 79: AZD7986 (DPP1 inhibitor): COPD

    Approved medicines Oncology Late-stage development AZD7986 (DPP1 inhibitor) Early development - IMED Early development - MedImmune Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 152 Part 1 (SAD) • Safety and tolerability a

  80. Slide 80: AZD8871 (MABA2): 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 CVMD Phase I Part 1: Mild Asthmatic N (Part 1) = 16 Part 1 Part 1 Endpoints: Part 1

  81. Slide 81: AZD9567 (oSGRM)

    Approved medicines Oncology Late-stage development AZD9567 (oSGRM) Early development - IMED Early development - MedImmune Respiratory Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 72 SAD trial with 8 dose levels – single ascending doses • A Phase I, Randomised, Sing

  82. Slide 82: AZD0284 (RORγ): plaque psoriasis vulgaris

    Approved medicines Oncology Late-stage development AZD0284 (RORγ) Early development - IMED Early development - MedImmune Plaque psoriasis vulgaris Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 80 Part 1 (SAD) • Safety and tolerability and PK following • FPCD: Q3 201

  83. Slide 83: Early development - MedImmune

    MedImmune Early development - MedImmune Research & Early Development

  84. Slide 84: Imfinzi (PD-L1 mAb): 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 CVMD Phase I/II Imfinzi Solid tumours 1,022 • Dose Escalation: 5 cohorts at Q2W and 1 cohort at Q3W • Safety

  85. Slide 85: Imfinzi + tremelimumab: cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Cancer CVMD Trial Population Patients Design Endpoints Status Phase Ib/II Gastric or GEJ 236 • Arm A: Imfinzi + tremelimumab 2L • Primary endpoint

  86. Slide 86: 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) CVMD Trial Population Patients Design Endpoints Status Phase I NSCLC 56 Escalation phase Primary endpoints: • FPCD: Q2

  87. Slide 87: Imfinzi + MEDI0680: cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + MEDI0680 (PD-1 mAb) Cancer CVMD Trial Population Patients Design Endpoints Status Phase I Advanced malignancies 96 Dose-escalation phase Primary endpoints: • FPCD: Q2 2014

  88. Slide 88: 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 CVMD Trial Population Patients Design Endpoints Status Phase I/II Metastatic or unresectable 69 Dose Escal

  89. Slide 89: Imfinzi + monalizumab: cancer

    Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development - IMED Early development - MedImmune + monalizumab (NKG2a mAb) Cancer CVMD Trial Population Patients Design Endpoints Status Phase I Advanced solid tumours 175 Escalation phase Primary endpoints: • FPCD: Q2 2016

  90. Slide 90: MEDI0457 + Imfinzi: head and neck cancer

    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) CVMD Trial Population Patients Design Endpoints Status Phase Ib/IIa Human papillomavirus (HPV) 50 Multi-centre

  91. Slide 91: 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) CVMD Cancer Trial Population Patients Design Endpoints Status Phase I Advanced malignancies Primary end

  92. Slide 92: 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 CVMD Phase I Adult subjects with select 51 Dose-escalation phase Primary endpoints: • FPCD: Q4 2015 advanced soli

  93. Slide 93: MEDI4276 (HER2 ADC mAb): cancer

    Approved medicines Oncology Late-stage development MEDI4276 (HER2 ADC mAb) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Advanced HER2+ metastatic Dose escalation • First-time-in-human Phase 1, multi-centre, open-label, s

  94. Slide 94: 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 CVMD Phase I Advanced Solid Tumours 204 Dose-escalation phase Primary endpoints: • FPCD: Q1 2017 • Part 1:

  95. Slide 95: MEDI7247 (PBD ADC mAb): cancer

    Approved medicines Oncology Late-stage development MEDI7247 (PBD ADC mAb) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Relapsed/Refractory 228 First-time-in-human Phase 1, multi-centre, open-label, single-arm, • Primary

  96. Slide 96: MEDI9197 (TLR7/8 agonist): cancer

    Approved medicines Oncology Late-stage development MEDI9197 (TLR7/8 agonist) Early development - IMED Early development - MedImmune Cancer Trial Population Patients Design Endpoints Status CVMD Phase I Advanced solid tumour 135 Dose-escalation phase Primary endpoints: • FPCD: Q4 2015 malignancies re

  97. Slide 97: MEDI9447 (CD73 mAb) + Imfinzi: cancer

    Approved medicines Oncology Late-stage development MEDI9447 (CD73 mAb) Early development - IMED Early development - MedImmune + Imfinzi (PD-L1 mAb) Cancer CVMD Trial Population Patients Design Endpoints Status Phase I Advanced malignancies 188 Dose-escalation phase Primary endpoints: • FPCD: Q3 2015

  98. Slide 98: Other biologics: cancer

    Approved medicines Oncology Late-stage development Other biologics Early development - IMED Early development - MedImmune Cancer Trial Compound Population Patients Design Endpoints Status CVMD Phase I/II Anti-IGF ligand Patients with HR+ 176 • Arm 1: MEDI-573 IV and aromatase inhibitor • PFS • FPCD:

  99. Slide 99: MEDI0382 (GLP-1-glucagon): diabetes

    Approved medicines Oncology Late-stage development MEDI0382 (GLP-1-glucagon) Early development - IMED Early development - MedImmune Diabetes Trial Population Patients Design Endpoints Status CVMD Phase I Healthy adult subjects 64 • SAD SC administration • Safety profile in terms of adverse events (A

  100. Slide 100: Biologics: cardiovascular and 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 CVMD Phase IIa rhLCAT Adults with stable 56 • SAD in stable CAD patients • Safety profile

  101. Slide 101: Tezepelumab (TSLP mAb): asthma

    Approved medicines Oncology Late-stage development Tezepelumab (MEDI9929, TSLP mAb) Early development - IMED Early development - MedImmune Asthma Trial Population Patients Design Endpoints Status CVMD Phase II Adult subjects with 584 • Arm 1: Placebo • Reduction in the annualised asthma • FPCD: Q2 2

  102. Slide 102: MEDI3506 (IL-33 mAb): COPD

    Approved medicines Oncology Late-stage development MEDI3506 (IL-33 mAb) Early development - IMED Early development - MedImmune COPD Trial Population Patients Design Endpoints Status CVMD Phase I (Combined SAD / SAD: Healthy subjects with SAD: 56 SAD: • Safety and tolerability • FPCD: Q2 2017 MAD) mi

  103. Slide 103: MEDI7836 (IL-13 mAb): asthma

    Approved medicines Oncology Late-stage development MEDI7836 (IL-13 mAb) Early development - IMED Early development - MedImmune Asthma Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 32 • Arm 1: 30mg MEDI7836 (6) or placebo (2) as a single • Safety and tolerability • F

  104. Slide 104: MEDI0700 - AMG: systemic lupus erythematosus

    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 CVMD Phase Ia Healthy subjects 48 Single Ascending Dose • Safety an

  105. Slide 105: MEDI1814 (amyloid beta mAb): 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 CVMD Phase I Alzheimer’s disease & healthy 121 • SAD & MAD • Safety, tolerability • FPCD: Q2 201

  106. Slide 106: MEDI5872 - AMG (B7RP-1 mAb): SLE

    Approved medicines Oncology Late-stage development MEDI5872 - AMG 557 (B7RP-1 mAb) Early development - IMED Early development - MedImmune Systemic lupus erythematosus (SLE) Trial Population Patients Design Endpoints Status CVMD Phase IIa Primary Sjögren's syndrome 42 • Arm 1: MEDI5872 210mg SC QW fo

  107. Slide 107: MEDI7352 (NGF TNF Bispecific): osteoarthritis pain

    Approved medicines Oncology Late-stage development MEDI7352 (NGF TNF Bispecific) Early development - IMED Early development - MedImmune Osteoarthritis pain Trial Population Patients Design Endpoints Status CVMD Phase I Painful osteoarthritis of the knee 160 • SAD & MAD • Safety, tolerability, PK, PD

  108. Slide 108: MEDI9314 (IL-4Ra mAb): atopic dermatitis

    Approved medicines Oncology Late-stage development MEDI9314 (IL-4Ra mAb) Early development - IMED Early development - MedImmune Atopic dermatitis Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 44 • Arm 1: 45mg MEDI9314 (4) or placebo (2) as a single SC dose • Safety

  109. Slide 109: Other biologics: autoimmunity

    Approved medicines Oncology Late-stage development Other biologics Early development - IMED Early development - MedImmune Autoimmunity Trial Compound Population Patients Design Endpoints Status CVMD Phase II/III Inebilizumab Adults with 212 (estimated) • Arm 1: inebilizumab 500mg IV • Primary: Time

  110. Slide 110: 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 CVMD Phase II Anti-Staph AT Intubated ICU 285 • Placebo-controlled, single-dose, dose-ranging • Efficacy and

  111. Slide 111: Clinical trials appendix: Year-to-date and Q3 2017 Results update

    Clinical trials appendix Year-to-date and Q3 2017 Results update

AstraZeneca — Q3 2017 Earnings Presentation on 6ix