Astrazeneca Plc · LSE:AZN

Astrazeneca — Q2 2017 Earnings Presentation

112 slides from Astrazeneca's earnings presentation, 2017

1. Slide 1: Clinical trials appendix Q2 2017 Results update

   Clinical trials appendix Q2 2017 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 2017, u

3. Slide 3: List of abbreviations

   List of abbreviations AE Adverse Event LCM Life-Cycle Management Q2W Quaque (every) Two Weeks AUC Area Under Curve LPCD Last Patient Commenced Dosing Q3W Quaque (every) Three Weeks BID Bis In Die (two times a day) MAD Multiple Ascending Dose Q4W Quaque (every) Four Weeks CE Clinically Evaluable MDI

4. Slide 4: Table of contents

   Table of contents slide Early development - IMED Movement since Q1 2017 update Oncology Q2 2017 New Molecular Entity (NME) Pipeline CVMD Q2 2017 Lifecycle Management (LCM) Pipeline Respiratory Other Approved medicines Oncology CVMD Early development - MedImmune Respiratory Oncology CVMD Respiratory

5. Slide 5: Movement since Q1 2017 update

   Movement since Q1 2017 update New to Phase I New to Phase II New to Pivotal Study New to Registration NME’s NME’s Additional indications Life-cycle Management AZD4785 verinurad acalabrutinib# Lynparza SOLO-2 [EU & JP]1 KRAS inhibitor solid tumours URAT1 inhibitor chronic kidney disease BTK inhibitor

6. Slide 6: Q2 2017 New Molecular Entity (NME) Pipeline

   Q2 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/

7. Slide 7: Q2 2017 Lifecycle Management (LCM) Pipeline

   Q2 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: Approved medicines

   AstraZeneca Approved medicines

9. Slide 9: Lynparza (PARP inhibitor) - Ovarian cancer

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

10. Slide 10: Lynparza (PARP inhibitor) - Solid tumours

    Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoints Status CVMD Phase III BRCAm metastatic breast 302 • Arm 1: Lynparza 300mg BiD, continuous to progression • Prim

11. Slide 11: Tagrisso - Non-small cell lung cancer

    Approved medicines Oncology Late-stage development Tagrisso Early development - IMED Early development - MedImmune (Highly-selective, irreversible EGFR TKI) Non-small cell lung cancer (NSCLC) CVMD Trial Population Patients Design Endpoints Status Phase III Advanced EGFRm NSCLC 410 • Arm 1: Tagrisso

12. Slide 12: Tagrisso - Non-small cell lung cancer

    Approved medicines Oncology Late-stage development Tagrisso Early development - IMED Early development - MedImmune (Highly-selective, irreversible EGFR TKI) Non-small cell lung cancer (NSCLC) CVMD Trial Population Patients Design Endpoints Status Phase Ib Advanced EGFRm NSCLC ~90 • Arm 1: Tagrisso +

13. Slide 13: Imfinzi - Non-small cell lung cancer

    Approved medicines Oncology Late-stage development Imfinzi (durvalumab, 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

14. Slide 14: Imfinzi + tremelimumab - Solid tumours

    Approved medicines Oncology Late-stage development Imfinzi (durvalumab, PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours CVMD Trial Population Patients Design Endpoints Status Phase III Stage IIIB-IV 3L NSCLC 480 • Arm 1: Imfinzi + tremelimu

15. Slide 15: Imfinzi - Head & Neck and other solid tumours

    Approved medicines Oncology Late-stage development Imfinzi (durvalumab, PD-L1 mAb) Early development - IMED Early development - MedImmune Squamous Cell Carcinoma of the Head & Neck (HNSCC) and other solid tumours CVMD Trial Population Patients Design Endpoints Status Phase I Solid tumours 108 • Dose

16. Slide 16: Imfinzi + tremelimumab - Solid tumours

    Approved medicines Oncology Late-stage development Imfinzi (durvalumab, PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours CVMD Trial Population Patients Design Endpoints Status Trial Population Patients Design Endpoints Status Phase III Advan

17. Slide 17: Brilinta - Cardiovascular

    Approved medicines Oncology Late-stage development Brilinta (ADP receptor antagonist) Early development - IMED Early development - MedImmune Cardiovascular Trial Population Patients Design Endpoints (primary) Status CVMD Phase III Patients with type-2 diabetes 19,000 • Arm 1: Brilinta 60mg BiD • Pri

18. Slide 18: Farxiga - Type-2 diabetes

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

19. Slide 19: Farxiga - Type-2 diabetes

    Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development - IMED Early development - MedImmune Type-2 diabetes Trial Population Patients Design Endpoints Status CVMD Phase III Patients With Chronic Heart 4,500 • Arm 1: Farxiga 10mg or 5 mg QD + standard of care t

20. Slide 20: 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

21. Slide 21: 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:

22. Slide 22: 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 Japanese patients with 375 • Epanova 2g and 4g vs Placebo (after meal) d

23. Slide 23: 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 I Healthy subjects 40 Part A • Arm 1: D1400147 4g • Rate and extent of absor

24. Slide 24: 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 •

25. Slide 25: 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

26. Slide 26: 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

27. Slide 27: 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 IV Patients with moderate COPD 268 • Arm 1: Duaklir Genuair

28. Slide 28: 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

29. Slide 29: 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 IIIb Moderate to severe COPD 150 Treatment (5- to 6- week

30. Slide 30: 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

31. Slide 31: 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

32. Slide 32: Late-stage pipeline

    AstraZeneca Late-stage pipeline

33. Slide 33: Acalabrutinib - Blood cancers

    Approved medicines Oncology Late-stage development 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: acalabrutinib • Primary endpoint: PFS • FP

34. Slide 34: Acalabrutinib - Blood cancers

    Approved medicines Oncology Late-stage development 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 combination of

35. Slide 35: Acalabrutinib - Blood cancers

    Approved medicines Oncology Late-stage development 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 • Acalabrutinib monotherapy • Safety • FPCD: Q2 2017 Advanced

36. Slide 36: Acalabrutinib - Solid tumours

    Approved medicines Oncology Late-stage development Acalabrutinib (BTK inhibitor) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoint(s) Status CVMD Phase II ≥ 2L advanced or metastatic 74 • Arm A: pembrolizumab • ORR • FPCD: Q2 2015 ACE-ST-0

37. Slide 37: Cediranib - Solid tumours

    Approved medicines Oncology Late-stage development Cediranib (VEGF-inhibitor) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoints Status CVMD Phase IIb PRR heavily pre-treated 100 • Cediranib 30 mg + Lynparza 200 mg bd • ORR DoR, DCR, QoL.

38. Slide 38: Moxetumomab pasudotox - Blood cancers

    Approved medicines Oncology Late-stage development Moxetumomab pasudotox (CD22 mAb) Early development - IMED Early development - MedImmune Blood cancers Trial Population Patients Design Endpoints Status CVMD Phase III Adults with relapsed or 77 • Multicentre, single-arm, open-label Phase III trial •

39. Slide 39: Savolitinib - Papillary renal cell and other cancers

    Approved medicines Oncology Late-stage development Savolitinib (AZD6094) (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 • Pr

40. Slide 40: Selumetinib - Solid tumours

    Approved medicines Oncology Late-stage development Selumetinib (MEK-inhibitor) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoints Status CVMD Phase III Differentiated thyroid cancer 304 • Arm 1: selumetinib 75mg BiD 5 weeks duration + RAI

41. Slide 41: Roxadustat - CKD/ESRD

    Approved medicines Oncology Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Chronic Kidney Disease/End Stage Renal Disease (CKD/ESRD) CVMD Trial Population Patients Design Endpoints Status Phase III ANDES Anaemia in CKD patients not 900 • Arm 1: rox

42. Slide 42: Roxadustat - CKD/ESRD

    Approved medicines Oncology Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Chronic Kidney Disease/End Stage Renal Disease (CKD/ESRD) CVMD Trial Population Patients Design Endpoints Status Phase III HIMALAYAS Anaemia in newly initiated 750 • Arm 1:

43. Slide 43: ZS-9 - Hyperkalaemia

    Approved medicines Oncology Late-stage development ZS-9 (Sodium zirconium cyclosilicate) Early development - IMED Early development - MedImmune Hyperkalaemia Trial Population Patients Design Endpoints Status CVMD Phase II Hyperkalaemia and moderate 90 • Arm 1: Escalating TID doses (0.3g, 3g and 10g)

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, 1,140 Cohort 1: • Primary endpoint: Asthma exacerbation

49. Slide 49: PT010 - COPD & 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 & 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 & 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 - Systemic Lupus Erythematosus

    Approved medicines Oncology Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Systemic Lupus Erythematosus (SLE) Trial Population Patients Design Endpoints Status CVMD Phase III Moderate to severe SLE 450 • Arm 1: 300mg IV anifrolumab

53. Slide 53: Anifrolumab - Lupus Nephritis

    Approved medicines Oncology Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Lupus Nephritis (LN) Trial Population Patients Design Endpoints Status CVMD Phase II Active Proliferative LN (TULIP- 150 • Arm 1: 900 mg IV Q4W for 12 weeks

54. Slide 54: Lanabecestat - Alzheimer's disease

    Approved medicines Oncology Late-stage development Lanabecestat (AZD3293, BACE inhibitor) Early development - IMED Early development - MedImmune Alzheimer’s disease Trial Population Patients Design Endpoints Status CVMD Phase III Early Alzheimer’s disease 2,202 • Arm 1: lanabecestat 20mg once daily

55. Slide 55: Acalabrutinib - Rheumatoid Arthritis

    Approved medicines Oncology Late-stage development Acalabrutinib (ACP-196) Early development - IMED Early development - MedImmune Rheumatoid Arthritis Trial Population Patients Design Endpoint(s) Status CVMD Phase II Rheumatoid Arthritis 31 • Arm A: acalabrutinib + methotrexate Disease Activity Scor

56. Slide 56: Early development - IMED

    AstraZeneca Early development - IMED

57. Slide 57: AZD0156 (ATM) - Solid tumours

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

58. Slide 58: AZD1775 (WEE-1)

    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 PR ovarian cancer 97 • Arm B: paclita

59. Slide 59: Vistusertib (AZD2014) - Breast and squamous 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 ER+ metastatic breast 316 • Arm 1: Fasl

60. Slide 60: AZD2811 (AURN) - Solid tumours

    Approved medicines Oncology Late-stage development AZD2811 (AURN) Early development - IMED Early development - MedImmune Solid tumours 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: A

61. Slide 61: AZD4547 (FGFR) - Solid tumours

    Approved medicines Oncology Late-stage development AZD4547 (FGFR) Early development - IMED Early development - MedImmune Solid tumours 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: MT

62. Slide 62: AZD4635 (A2AR)

    Approved medicines Oncology Late-stage development AZD4635 (A2AR) Early development - IMED Early development - MedImmune Solid tumours and Non-Small Cell Lung Cancer (NSCLC) Trial Population Patients Design Endpoints Status CVMD Phase I Phase Ia: patients with 36 (estimated) • Phase 1a: dose escalat

63. Slide 63: AZD4785 (KRAS antisense oligonucleotide)

    Approved medicines Oncology Late-stage development AZD4785 (KRAS antisense oligonucleotide) Early development - IMED Early development - MedImmune Solid tumours and Non-Small Cell Lung Cancer (NSCLC) Trial Population Patients Design Endpoints Status CVMD Phase I Phase Ia: patients with 30 (estimated

64. Slide 64: AZD5069 (CXCR2) - Solid tumours

    Approved medicines Oncology Late-stage development AZD5069 (CXCR2) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoints Status CVMD Phase Ib/II Squamous Cell Carcinoma of 233 Dose Escalation advanced solid and blood cancers • Safety/Efficacy

65. Slide 65: AZD5363 (AKT) - Solid tumours

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

66. Slide 66: AZD6738 (ATR) - Solid tumours

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

67. Slide 67: AZD8186 (PI3Kb/d) - Solid tumours

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

68. Slide 68: AZD9150 (STAT3)

    Approved medicines Oncology Late-stage development AZD9150 (STAT3) Early development - IMED Early development - MedImmune Solid tumours and blood cancers Trial Population Patients Design Endpoints Status CVMD Phase Ib/II Squamous Cell Carcinoma of 233 Dose Escalation advanced solid and blood cancers

69. Slide 69: 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 a Phase I open label multicentre trial of AZD9496 • Primary Outcome Me

70. Slide 70: AZD4076 - NASH

    Approved medicines Oncology Late-stage development AZD4076 (anti-miR 103/107) Early development - IMED Early development - MedImmune Non-alcoholic steatohepatitis (NASH) Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 40 SAD trial (one trial site in US) • Safety and t

71. Slide 71: AZD4831 (MPO) - Cardiovascular disease

    Approved medicines Oncology Late-stage development AZD4831 (MPO) Early development - IMED Early development - MedImmune Cardiovascular disease Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects ~96 SAD trial (one trial site in Germany) • Safety and tolerability • FPCD: Q

72. Slide 72: AZD5718 (FLAP) - Cardiovascular disease

    Approved medicines Oncology Late-stage development AZD5718 (FLAP) Early development - IMED Early development - MedImmune Cardiovascular disease Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 96 SMAD trial (one trial site in UK) • Safety and tolerability • FPCD: Q1 20

73. Slide 73: 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

74. Slide 74: Verinurad - CKD development programme

    Approved medicines Oncology Late-stage development Verinurad (RDEA3170 - SURI, URAT1 inhibitor) Early development - IMED Early development - MedImmune CKD development programme Trial Population Patients Design Endpoints Status CVMD Phase II CKD patients with 60 • Arm A: verinurad 9 mg and febuxostat

75. Slide 75: Abediterol (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

76. Slide 76: 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, 70 • Arm 1: AZD1419, once-weekly adaptive dosing (4mg, 1mg, • Time to los

77. Slide 77: 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

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 II Patients with mild to moderate 48 A randomised, double

79. Slide 79: 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 Randomized Open Label Three-Way Cr

80. Slide 80: 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

81. Slide 81: 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

82. Slide 82: 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

83. Slide 83: AZD0284 (RORγ) - Plaque Psoriasis

    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

84. Slide 84: AZD3241 (MPO) - Parkinson's disease

    Approved medicines Oncology Late-stage development AZD3241 (MPO) Early development - IMED Early development - MedImmune Parkinson’s disease Trial Population Patients Design Endpoints Status CVMD Phase II Parkinson’s disease patients 24 • Arm 1: AZD3241 600mg BID for 8 weeks • Microglia activation re

85. Slide 85: Early development - MedImmune

    MedImmune Early development - MedImmune

86. Slide 86: Imfinzi - Immuno-oncology

    Approved medicines Oncology Late-stage development Imfinzi (durvalumab, PD-L1 mAb) Early development - IMED Early development - MedImmune Immuno-oncology Trial Compound Population Patients Design Endpoints Status CVMD Phase I/II Imfinzi Solid tumours 1,014 • Dose Escalation: 5 cohorts at Q2W and 1 c

87. Slide 87: Imfinzi + tremelimumab - Solid and hematologic tumours

    Approved medicines Oncology Late-stage development Imfinzi (durvalumab, PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid and hematologic tumours CVMD Trial Population Patients Design Endpoints Status Phase Ib/II Gastric or GEJ 236 • Arm A: Imfinzi +

88. Slide 88: Imfinzi + Iressa - NSCLC

    Approved medicines Oncology Late-stage development Imfinzi (durvalumab, 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

89. Slide 89: Imfinzi + MEDI0680 - Advanced cancers

    Approved medicines Oncology Late-stage development Imfinzi (durvalumab, PD-L1 mAb) Early development - IMED Early development - MedImmune + MEDI0680 (PD-1 mAb) Advanced cancers CVMD Trial Population Patients Design Endpoints Status Phase I Advanced malignancies 150 Dose-escalation phase Primary endp

90. Slide 90: Imfinzi + dabrafenib/trametinib - Melanoma

    Approved medicines Oncology Late-stage development Imfinzi (durvalumab, 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 6

91. Slide 91: Imfinzi + Monalizumab - Advanced Solid Tumours

    Approved medicines Oncology Late-stage development Imfinzi (durvalumab, PD-L1 mAb) Early development - IMED Early development - MedImmune + Monalizumab (NKG2a mAb) Advanced Solid Tumours CVMD Trial Population Patients Design Endpoints Status Phase I Advanced solid tumours 175 Escalation phase Primar

92. Slide 92: MEDI0562 (OX40 mAb) - Advanced cancers

    Approved medicines Oncology Late-stage development MEDI0562 (OX40 mAb) Early development - IMED Early development - MedImmune MEDI0562 (OX40 mAb) + Imfinzi (durvalumab, PD-L1 mAb) or tremelimumab (CTLA-4 mAb) CVMD Advanced cancers Trial Population Patients Design Endpoints Status Respiratory Phase I

93. Slide 93: MEDI1873 (GITR agonist) - Solid tumours

    Approved medicines Oncology Late-stage development MEDI1873 (GITR agonist) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoints Status CVMD Phase I Adult subjects with select 42 Dose-escalation phase Primary endpoints: • FPCD: Q4 2015 advanc

94. Slide 94: MEDI4276 (HER2 ADC mAb) - Advanced cancers

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

95. Slide 95: MEDI5083 + Imfinzi - Advanced Solid Tumours

    Approved medicines Oncology Late-stage development MEDI5083 + Imfinzi (durvalumab, PD-L1 mAb) Early development - IMED Early development - MedImmune Advanced Solid Tumours Trial Population Patients Design Endpoints Status CVMD Phase I Advanced Solid Tumours 204 Dose-escalation phase Primary endpoint

96. Slide 96: MEDI7247 (PBD ADC mAb) - Advanced cancers

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

97. Slide 97: MEDI9197 (TLR7/8 agonist) - Solid tumours

    Approved medicines Oncology Late-stage development MEDI9197 (TLR7/8 agonist) Early development - IMED Early development - MedImmune Solid tumours Trial Population Patients Design Endpoints Status CVMD Phase I Advanced solid tumour 78 Dose-escalation phase Primary endpoints: • FPCD: Q4 2015 malignanc

98. Slide 98: MEDI9447 (CD73 mAb) + Imfinzi

    Approved medicines Oncology Late-stage development MEDI9447 (CD73 mAb) Early development - IMED Early development - MedImmune + Imfinzi (durvalumab, PD-L1 mAb) Advanced cancers CVMD Trial Population Patients Design Endpoints Status Phase I Advanced malignancies 188 Dose-escalation phase Primary endp

99. Slide 99: Other biologics - Solid tumours

    Approved medicines Oncology Late-stage development Other biologics Early development - IMED Early development - MedImmune Solid tumours 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

100. Slide 100: Biologics - Cardiovascular & metabolic disease

     Approved medicines Oncology Late-stage development Biologics Early development - IMED Early development - MedImmune Cardiovascular & metabolic disease 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 552 • 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 - 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 40 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 (B7RP-1 mAb) - Systemic Lupus Erythematosus

     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 462 • Placebo-controlled, single-dose, dose-ranging • Efficacy and

111. Slide 111: 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 Ib/IIa Anti-influenza A Adults 160 • Randomised, partial double-blind, single dose, • Evaluate sa

112. Slide 112: Clinical trials appendix Q2 2017 Results update

     Clinical trials appendix Q2 2017 Results update

AstraZeneca — Q2 2017 Earnings Presentation on 6ix