Slide 1: Clinical Trials Appendix Q4 2015 Update
Clinical Trials Appendix Q4 2015 Update
Slide 2: About AstraZeneca clinical study information
The following information about AstraZeneca clinical studies in Phases I-IV has been created with selected information from clinicaltrials.gov to facilitate understanding of key aspects of our clinical programmes and is correct to the best of our knowledge as of 31 December 2015, unless otherwise s
Slide 3: List of abbreviations
List of abbreviations AEs Adverse E vents LCM Lifecycle Management Q3W Every Three Weeks ASA Acetylsalicylic Acid LPD Last P atient Dosed Q4W Every Four Weeks BiD Twice Daily MAD Multiple Ascending Dose Study Q8W Every Eight Weeks CE Clinically Evaluable MDI Metered Dose Inhaler QD Once Daily cMITT
Slide 4: Movement since Q3 2015
Movement since Q3 2015 New to Phase I New to Phase II New to Pivotal Study New to Registration NMEs NMEs NME NMEs AZD0156 AZD3759 or Tagrisso (AZD9291) BLOOM acalabrutinib#1 brodalumab [US, EU] ATM serine/threonine kinase solid tumours EGFR brain metastases in advanced EGFRm NSCLC B-cell blood canc
Slide 5: Q4 2015 New Molecular Entity (NME) Pipeline
Q4 2015 New Molecular Entity (NME)1 Pipeline RIA CVMD Oncology Infection, Neuroscience, Gastrointestinal 1 Includes significant fixed dose combination projects, and parallel indications that are in a separate therapeutic area (See LCM chart for other parallel indications and oncology combination pro
Slide 6: Q4 2015 Lifecycle Management (LCM) Pipeline
Q4 2015 Lifecycle Management (LCM)1 Pipeline RIA CVMD Oncology Infection, Neuroscience, Gastrointestinal 1 Includes significant LCM projects and parallel indications for assets in P 3 or beyond. Excludes LCM projects already launched in a major market # Partnered and/or in collaboration;; ¶ Registra
Slide 7: Lifecycle management (new uses of existing medicines)
AstraZeneca Lifecycle management (new uses of existing medicines)
Slide 8: Symbicort (ICS/LABA) Mild asthma
Lifecycle management Late-stage development Symbicort (ICS/LABA) Early development - IMED Early development - MedImmune Mild asthma Study phase Patient population Number of patients Design Endpoints Status Phase III Patients in need of GINA step N = 3,750 • Arm 1: Symbicort Turbuhaler 160/4.5 μg
Slide 9: Eklira/Tudorza (LAMA) COPD
Lifecycle management Late-stage development Eklira/Tudorza (LAMA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Study phase Patient population Number of patients Design Endpoints Status Phase IV Patients with COPD N = 224 • Arm 1: Aclidinium b
Slide 10: Duaklir (LAMA/LABA) COPD
Lifecycle management Late-stage development Duaklir (LAMA/LABA) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Study phase Patient population Number of patients Design Endpoints Status Phase IV Patients with moderate to N = 268 • Arm 1: Aclidin
Slide 11: Daxas/DaliResp (oral PDE4 inhibitor) COPD
Lifecycle management Late-stage development Daxas/DaliResp (oral PDE4 inhibitor) Early development - IMED Early development - MedImmune Chronic Obstructive Pulmonary Disease (COPD) Study phase Patient population Number of patients Design Endpoints Status Phase IV COPD N = 2,354 • 52W, Randomised,
Slide 12: Zurampic (lesinurad) Gout
Lifecycle management Late-stage development Zurampic (lesinurad) (SURI, URAT1 inhibitor) Early development - IMED Early development - MedImmune Gout Study phase Patient population Number of patients Design Endpoints Status Phase III Gout previously enrolled in N = 717 • Zurampic 200 or 400 mg QD
Slide 13: Zurampic/Allopurinol FDC Gout
Lifecycle management Late-stage development Zurampic (lesinurad)/Allopurinol FDC Early development - IMED Early development - MedImmune (SURI, URAT1 inhibitor/XOI inhibitor) Gout Study phase Patient population Number of patients Design Endpoints Status Phase I Healthy Male Subjects N = 74 Cohort
Slide 14: Brilinta/Brilique Cardiovascular
Lifecycle management Late-stage development Brilinta/Brilique (ADP receptor antagonist) Early development - IMED Early development - MedImmune Cardiovascular Study phase Patient population Number of patients Design Endpoints Status Phase III Patients with prior MI N = 21,000 • Arm 1: Ticagrelor 9
Slide 15: Epanova Hypertriglyceridaemia
Lifecycle management Late-stage development Epanova (omega-3 carboxylic acids) Early development - IMED Early development - MedImmune Hypertriglyceridaemia Study phase Patient population Number of patients Design Endpoints Status Phase III Japanese patients with N = 375 • Epanova 2 g and 4 g vs.
Slide 16: Epanova Hypertriglyceridaemia
Lifecycle management Late-stage development Epanova (omega-3 carboxylic acids) Early development - IMED Early development - MedImmune Hypertriglyceridaemia Study phase Patient population Number of patients Design Endpoints Status Phase I Healthy volunteers N = 40 Part A • Arm 1: D1400147 4g • Ra
Slide 17: Onglyza (DPP-4 inhibitor) Type 2 Diabetes
Lifecycle management Late-stage development Onglyza (DPP-4 inhibitor) Early development - IMED Early development - MedImmune Type 2 Diabetes Study phase Patient population Number of patients Design Endpoints Status Phase III Type 2 diabetes mellitus N = 444 • Arm 1: Onglyza 5 mg QD +insulin or O
Slide 18: Farxiga/Forxiga (SGLT-2 inhibitor) Diabetes
Lifecycle management Late-stage development Farxiga/Forxiga (SGLT-2 inhibitor) Early development - IMED Early development - MedImmune Diabetes Study phase Patient population Number of patients Design Endpoints Status Phase IV Japanese patients with type 2 N = 266 • Arm 1: Forxiga 5mg • Change fr
Slide 19: Saxagliptin/dapagliflozin Diabetes
Lifecycle management Late-stage development Saxagliptin/dapagliflozin (DPP-4/SGLT-2 inhibitors) Early development - IMED Early development - MedImmune Diabetes Study phase Patient population Number of patients Design Endpoints Status Phase III Type 2 diabetes mellitus N = 420 • Arm 1: Saxa 5 mg
Slide 20: Bydureon (GLP-1 receptor agonist) Type 2 Diabetes
Lifecycle management Late-stage development Bydureon (GLP-1 receptor agonist) Early development - IMED Early development - MedImmune Type 2 Diabetes Study phase Patient population Number of patients Design Endpoints Status Phase IV Type 2 diabetes N = 14,000 • Arm 1: Bydureon once weekly 2mg SC
Slide 21: Bydureon (GLP-1 receptor agonist) Type 2 Diabetes
Lifecycle management Late-stage development Bydureon (GLP-1 receptor agonist) Early development - IMED Early development - MedImmune Type 2 Diabetes Study phase Patient population Number of patients Design Endpoints Status Phase III Type 2 diabetes N = 660 • Arm 1: Bydureon once weekly 2 mg SC •
Slide 22: Faslodex Breast cancer - metastatic
Lifecycle management Late-stage development Faslodex (oestrogen receptor antagonist) Early development - IMED Early development - MedImmune Breast cancer - metastatic Study phase Patient population Number of patients Design Endpoints Status Phase III Postmenopausal women with N ~450 • Arm 1: Fas
Slide 23: Lynparza (PARP inhibitor) Ovarian cancer
Lifecycle management Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer and other solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase III PSR BRCAm ovarian cancer N = 264 • Arm 1: Lynparz
Slide 24: Lynparza (PARP inhibitor) Solid tumours
Lifecycle management Late-stage development Lynparza (PARP inhibitor) Early development - IMED Early development - MedImmune Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase III BRCAm metastatic breast N = 310 • Arm 1: Lynparza 300 mg BiD, c ontinuous
Slide 25: Tagrisso NSCLC
Lifecycle management Late-stage development Tagrisso (Highly selective, irreversible EGFR TKI) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Study phase Patient population Number of patients Design Endpoints Status Phase III Advanced EGFRm NSCLC N = 41
Slide 26: Tagrisso NSCLC
Lifecycle management Late-stage development Tagrisso (Highly selective, irreversible EGFR TKI) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Study phase Patient population Number of patients Design Endpoints Status Phase Ib Advanced EGFRm NSCLC N ~ 90
Slide 27: Nexium Gastrointestinal
Lifecycle management Late-stage development Nexium Early development - IMED Early development - MedImmune Gastrointestinal Study phase Patient population Number of patients Design Endpoints Status Phase III Seriously ill patients with at N = 300 • Arm 1: Nexium 40 mg bid intermittent • Clinically
Slide 28: Late-stage development
AstraZeneca Late-stage development
Slide 29: PT003 (LABA/LAMA) COPD
Lifecycle management Late-stage development PT003 (LABA/LAMA) Early development - IMED Early development - MedImmune COPD Study phase Patient population Number of patients Design Endpoints Status Phase III Moderate to very severe N = 2,103 Treatment (24-week Treatment Period) • Change from basel
Slide 30: PT003 (LABA/LAMA) COPD
Lifecycle management Late-stage development PT003 (LABA/LAMA) Early development - IMED Early development - MedImmune COPD Study phase Patient population Number of patients Design Endpoints Status Phase IIIb Moderate to severe COPD N = 150 Treatment ( 5- to 6- week Treatment Period) • Percentage
Slide 31: PT003 (LABA/LAMA) COPD
Lifecycle management Late-stage development PT003 (LABA/LAMA) Early development - IMED Early development - MedImmune COPD Study phase Patient population Number of patients Design (G = Glycopyrronium, F = Formoterol fumarate) Endpoints Status Phase III Moderate to very severe N = 1,614 Treatments
Slide 32: PT009 (ICS/LABA) COPD & Asthma
Lifecycle management Late-stage development PT009 (ICS/LABA) Early development - IMED Early development - MedImmune COPD & Asthma Study phase Patient population Number of patients Design (G = Glycopyrronium, F = Formoterol fumarate) Endpoints Status Phase II Moderate to severe COPD N = 180 • BFF
Slide 33: PT010 (LABA/LAMA/ICS) COPD & Asthma
Lifecycle management Late-stage development PT010 (LABA/LAMA/ICS) Early development - IMED Early development - MedImmune COPD & Asthma Study phase Patient population Number of patients Design Endpoints Status Phase III Moderate to very severe N = 500 Treatments ( 52-week Treatment Period) Bone M
Slide 34: PT010 (LABA/LAMA/ICS) COPD & Asthma
Lifecycle management Late-stage development PT010 (LABA/LAMA/ICS) Early development - IMED Early development - MedImmune COPD & Asthma Study phase Patient population Number of patients Design Endpoints Status Phase II Adult mild to moderate N = 150 • Arm 1: BD MDI 320 μg BiD • Change from baselin
Slide 35: PT010 (LABA/LAMA/ICS) COPD & Asthma
Lifecycle management Late-stage development PT010 (LABA/LAMA/ICS) Early development - IMED Early development - MedImmune COPD & Asthma Study phase Patient population Number of patients Design Endpoints Status Phase I Healthy volunteers N = 72 • Arm 1: BGF MDI 320/14.4/9.6 μg • Overall safety • FP
Slide 36: Benralizumab (IL-5Rα mAb) Asthma
Lifecycle management Late-stage development Benralizumab (IL-5Rα mAb) Early development - IMED Early development - MedImmune Asthma Study phase Patient population Number of patients Design Endpoints Status Phase III Severe asthma, inadequately N = 1,026 HD + ~200 • Arm 1: 30 mg Q8w SC • Annual a
Slide 37: Benralizumab (IL-5Rα mAb) Asthma
Lifecycle management Late-stage development Benralizumab (IL-5Rα mAb) Early development - IMED Early development - MedImmune Asthma Study phase Patient population Number of patients Design Endpoints Status Phase III Asthmatic with FEV1 (50-90% N = 200 • Arm 1: 30 mg Q4w SC • Pulmonary function
Slide 38: Benralizumab (IL-5Rα mAb) COPD
Lifecycle management Late-stage development Benralizumab (IL-5Rα mAb) Early development - IMED Early development - MedImmune COPD Study phase Patient population Number of patients Design Endpoints Status Phase III Moderate to very severe N = 2,168 • Arm 1: 10 mg Q8w SC • Rate of COPD exacerbatio
Slide 39: Tralokinumab (IL-13 mAb) Asthma
Lifecycle management Late-stage development Tralokinumab (IL-13 mAb) Early development - IMED Early development - MedImmune Asthma Study phase Patient population Number of patients Design Endpoints Status Phase III Adults with uncontrolled N = 1,140 Cohort 1: Primary: • FPD: Q3 14 STRATOS 1 seve
Slide 40: Tralokinumab Idiopathic Pulmonary Fibrosis
Lifecycle management Late-stage development Tralokinumab (IL-13 mAb) Early development - IMED Early development - MedImmune Idiopathic Pulmonary Fibrosis (IPF) Study phase Patient population Number of patients Design Endpoints Status Phase II Adults with Idiopathic N = 176 • Arm 1: Tralokinumab
Slide 41: Tralokinumab Atopic dermatitis
Lifecycle management Late-stage development Tralokinumab (IL-13 mAb) Early development - IMED Early development - MedImmune Atopic dermatitis Study phase Patient population Number of patients Design Endpoints Status Phase II Adults with atopic dermatitis N = 204 • Arm 1: Tralokinumab dose 45mg S
Slide 42: Anifrolumab Systemic Lupus Erythematosus
Lifecycle management Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Systemic Lupus Erythematosus (SLE) Study phase Patient population Number of patients Design Endpoints Status Phase III Moderate to severe Systemic N = 450 • Arm
Slide 43: Anifrolumab Lupus Nephritis
Lifecycle management Late-stage development Anifrolumab (type I IFN receptor mAb) Early development - IMED Early development - MedImmune Lupus Nephritis (LN) Study phase Patient population Number of patients Design Endpoints Status Phase II Active Proliferative Lupus N = 150 • Arm 1: 900 mg IV Q4
Slide 44: Brodalumab (IL-17R mAb) Psoriasis
Lifecycle management Late-stage development Brodalumab (IL-17R mAb) Early development - IMED Early development - MedImmune Psoriasis Study phase Patient population Number of patients Design Endpoints Status Phase III Moderate to severe plaque N = 661 • Arm 1: 210 mg brodalumab SC • PASI at wk 12
Slide 45: Roxadustat (HIF-PHI) Chronic Kidney Disease
Lifecycle management Late-stage development Roxadustat (HIF-PHI) Early development - IMED Early development - MedImmune Chronic Kidney Disease (CKD) Study phase Patient population Number of patients Design Endpoints Status Phase III ANDES Anaemia in Chronic Kidney N = 600 • Arm 1: Roxadustat Hae
Slide 46: Tremelimumab (CTLA-4 mAb) Mesothelioma
Lifecycle management Late-stage development Tremelimumab (CTLA-4 mAb) Early development - IMED Early development - MedImmune Mesothelioma Study phase Patient population Number of patients Design Endpoints Status Phase II Patients with unresectable N = 564 • Arm 1: Tremelimumab IV • Primary: Over
Slide 47: Durvalumab (PD-L1 mAb) NSCLC
Lifecycle management Late-stage development Durvalumab (MEDI4736;; PD-L1 mAb) Early development - IMED Early development - MedImmune Non-small cell lung cancer (NSCLC) Study phase Patient population Number of patients Design Endpoints Status Phase III Adjuvant NSCLC patients N = 1,100 • Arm 1:
Slide 48: Durvalumab SCCHN and other solid tumours
Lifecycle management Late-stage development Durvalumab (MEDI4736;; PD-L1 mAb) Early development - IMED Early development - MedImmune SCCHN and other solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase II SCCHN N = 112 • Single-arm: MEDI4736 IVQ2W • ORR
Slide 49: Durvalumab + tremelimumab Solid tumours
Lifecycle management Late-stage development Durvalumab (MEDI4736;; PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase III Stage IIIB-IV 3L NSCLC N = 480 • Ar
Slide 50: Durvalumab + tremelimumab Solid tumours
Lifecycle management Late-stage development Durvalumab (MEDI4736;; PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase II SCCHN N = 240 • Arm 1: MEDI4736 • ORR
Slide 51: Cediranib (VEGF inhibitor) Ovarian cancer
Lifecycle management Late-stage development Cediranib (VEGF inhibitor) Early development - IMED Early development - MedImmune Ovarian cancer Study phase Patient population Number of patients Design Endpoints Status Phase III Patients with platinum- N = 486 • Arm 1: Placebo • Progression Free Sur
Slide 52: Moxetumomab pasudotox Haematological malignancies
Lifecycle management Late-stage development Moxetumomab pasudotox (CD22 mAb) Early development - IMED Early development - MedImmune Haematological malignancies Study phase Patient population Number of patients Design Endpoints Status Phase III Adults with relapsed or N = 77 • Multicentre, single-
Slide 53: Selumetinib (MEK inhibitor) Solid tumours
Lifecycle management Late-stage development Selumetinib (AZD6244) (MEK-inhibitor) Early development - IMED Early development - MedImmune Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase III 2L KRASm positive NSCLC N = 500 • Arm 1: Selumetinib 75mg BiD
Slide 54: Acalabrutinib Haematological malignancies
Lifecycle management Late-stage development Acalabrutinib (ACP-196) Early development - IMED Early development - MedImmune Haematological malignancies Study phase Patient population Number of patients Design Endpoint(s) Status Phase III Previously treated patients N = 500 • Arm A: acalabrutinib
Slide 55: Acalabrutinib Haematological malignancies
Lifecycle management Late-stage development Acalabrutinib (ACP-196) Early development - IMED Early development - MedImmune Haematological malignancies Study phase Patient population Number of patients Design Endpoint(s) Status Phase II Patients with advanced head N = 74 • Arm A: pembrolizumab Sa
Slide 56: CAZ AVI Serious infections
Lifecycle management Late-stage development CAZ AVI (BLI/cephalosporin SBI) Early development - IMED Early development - MedImmune Serious infections Study phase Patient population Number of patients Design Endpoints Status Phase III Hospitalised adults with N = 563 • Arm 1: CAZ-AVI 2000/500mg I
Slide 57: AZD3293 (BACE inhibitor) Alzheimer's disease
Lifecycle management Late-stage development AZD3293 (BACE inhibitor) Early development - IMED Early development - MedImmune Alzheimer’s disease Study phase Patient population Number of patients Design Endpoints Status Phase II/III Alzheimer’s disease patients N = 2,202 • Arm 1: AZD3293 20 mg once
Slide 58: Early development - IMED
AstraZeneca Early development - IMED
Slide 59: AZD7594 (inhaled SGRM) Asthma/COPD
Lifecycle management Late-stage development AZD7594 (inhaled SGRM) Early development - IMED Early development - MedImmune Asthma/COPD Study phase Patient population Number of patients Design Endpoints Status Phase II Patients with mild to moderate N = 48 Sequence 1 • Forced expiratory volume in o
Slide 60: AZD7624 (p38 inhibitor) COPD
Lifecycle management Late-stage development AZD7624 (p38 inhibitor) Early development - IMED Early development - MedImmune COPD Study phase Patient population Number of patients Design Endpoints Status Phase IIa COPD N = 212 • Arm 1: AZD7624, 1.0mg • Effect on rate of exacerbations and lung • FPD
Slide 61: AZD7986 (DPP1 inhibitor) COPD
Lifecycle management Late-stage development AZD7986 (DPP1 inhibitor) Early development - IMED Early development - MedImmune COPD Study phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = 152 Part 1 (SAD) • Safety and tolerability and PK following • FPD
Slide 62: AZD8999 (MABA1) Asthma/COPD
Lifecycle management Late-stage development AZD8999 (MABA1) Early development - IMED Early development - MedImmune Asthma/COPD Study phase Patient population Number of patients Design Endpoints Status Phase I Part 1: Mild Asthmatic N (Part 1) = 17 Part 1 Part 1 Endpoints: Part 1 SAD study with 6
Slide 63: AZD8871 (MABA2) Asthma/COPD
Lifecycle management Late-stage development AZD8871 (MABA2) Early development - IMED Early development - MedImmune Asthma/COPD Study phase Patient population Number of patients Design Endpoints Status Phase I Part 1: Mild Asthmatic N (Part 1) = 16 Part 1 Part 1 Endpoints: Part 1 SAD study with 6
Slide 64: AZD9412 (Inhaled IFN-beta) Asthma
Lifecycle management Late-stage development AZD9412 (Inhaled IFN-beta) Early development - IMED Early development - MedImmune Asthma Study phase Patient population Number of patients Design Endpoints Status Phase IIa Asthma N = 220 • Arm 1: 24 μg (metered dose) AZD9412 once daily for 14 • Propor
Slide 65: RDEA3170 (SURI, URAT1 inhibitor) Gout
Lifecycle management Late-stage development RDEA3170 (SURI, URAT1 inhibitor) Early development - IMED Early development - MedImmune Gout and hyperuricemia development programme Study phase Patient population Number of patients Design Endpoints Status Phase II Monotherapy study in s ubjects N = 16
Slide 66: RDEA3170 Gout and hyperuricemia
Lifecycle management Late-stage development RDEA3170 (SURI, URAT1 inhibitor) Early development - IMED Early development - MedImmune Gout and hyperuricemia Study phase Patient population Number of patients Design Endpoints Status Phase II Combination therapy study N = 40 • Arm A: Placebo • To asse
Slide 67: AZD9567 (oSGRM) Rheumatoid Arthritis
Lifecycle management Late-stage development AZD9567 (oSGRM) Early development - IMED Early development - MedImmune Rheumatoid Arthritis Study phase Patient population Number of subjects Design Endpoints Status Phase I Healthy Volunteers N = 72 SAD study with 6 dose levels - 2 μg, 10 μg, 40 μg, 1
Slide 68: AZD9977 Diabetic kidney disease
Lifecycle management Late-stage development AZD9977 (mineralocorticoid receptor modulator) Early development - IMED Early development - MedImmune Diabetic kidney disease Study phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = up to 88 Part A: Single
Slide 69: AZD4901 (NK3 Receptor Antagonist)
Lifecycle management Late-stage development AZD4901 (NK3 Receptor Antagonist) Early development - IMED Early development - MedImmune Phase II clinical development programme Study phase Patient population Number of patients Design Endpoints Status Phase IIa Polycystic ovary syndrome N = 56 • Arm 1
Slide 70: AZD4076 (anti-miR 103/107) NASH
Lifecycle management Late-stage development AZD4076 (anti-miR 103/107) Early development - IMED Early development - MedImmune Non-alcoholic Steatohepatitis (NASH) Study phase Patient population Number of patients Design Endpoints Status Phase I Healthy subjects N = up to 48 Single Ascending Dos
Slide 71: AZD1775 (WEE-1)
Lifecycle management Late-stage development AZD1775 (WEE-1) Early development - IMED Early development - MedImmune Solid tumours, ovarian cancer and non-small cell lung cancer Study phase Patient population Number of patients Design Endpoints Status Phase II p53 mutant PSR ovarian N = 120 • Arm
Slide 72: Savolitinib (AZD6094) (MET)
Lifecycle management Late-stage development Savolitinib (AZD6094) (MET) Early development - IMED Early development - MedImmune Papillary renal cell and other cancers Study phase Patient population Number of patients Design Endpoints Status Phase II Papillary renal cell cancer N = 90 • Single arm
Slide 73: AZD2014 (TORC 1/2)
Lifecycle management Late-stage development AZD2014 (TORC 1/2) Early development - IMED Early development - MedImmune Breast and squamous NSCLC cancer Study phase Patient population Number of patients Design Endpoints Status Phase IIa Relapsed or refractory N = 40 Open label • Primary: ORR accord
Slide 74: AZD3759 (EGFRm BBB)
Lifecycle management Late-stage development AZD3759 (EGFRm BBB) Early development - IMED Early development - MedImmune Lung cancer with lung and/or brain metastases Study phase Patient population Number of patients Design Endpoints Status Phase I EGFRm+ NSCLC N = 47 • MAD • Safety and tolerabilit
Slide 75: AZD4547 (FGFR)
Lifecycle management Late-stage development AZD4547 (FGFR) Early development - IMED Early development - MedImmune Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase II/III Lung Master Stage IIIB-IV NSCLC patients N = 318 (AZD4547 5-Arm study based on b
Slide 76: AZD4547 (FGFR)
Lifecycle management Late-stage development AZD4547 (FGFR) Early development - IMED Early development - MedImmune Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase I Advanced cancer who have N = 94 • Part A: Ascending oral doses of A ZD4547 to define •
Slide 77: AZD9496 (SERD)
Lifecycle management Late-stage development AZD9496 (SERD) Early development - IMED Early development - MedImmune Breast cancer Study phase Patient population Number of patients Design Endpoints Status Phase I ER+ Breast Cancer N ~150 • This is a Phase I open label multicentre study of AZD9496 •
Slide 78: AZD5312 (ISIS-AR)
Lifecycle management Late-stage development AZD5312 (ISIS-AR) Early development - IMED Early development - MedImmune Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase I Advanced solid tumours with N = 90 Part A: Dose escalation • Part A: MTD and Recomm
Slide 79: AZD5363 (AKT)
Lifecycle management Late-stage development AZD5363 (AKT) Early development - IMED Early development - MedImmune Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase IIb ER+ breast cancer receiving N = 100 • Arm 1: AZD5363 + paclitaxel • Progression Free s
Slide 80: AZD6738 (ATR)
Lifecycle management Late-stage development AZD6738 (ATR) Early development - IMED Early development - MedImmune Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase I Solid tumours N = 160 • Arm 1: AZD6738 + carboplatin • Safety and tolerability • FPD: Q4
Slide 81: AZD8186 (PI3Kb/d)
Lifecycle management Late-stage development AZD8186 (PI3Kb/d) Early development - IMED Early development - MedImmune Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase I Advanced N = 96 • Part A: AZD8186 monotherapy in ascending intermittent • Part A: PK
Slide 82: AZD8835 (PI3Kα/δ inhibitor)
Lifecycle management Late-stage development AZD8835 (PI3Kα/δ inhibitor) Early development - IMED Early development - MedImmune Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase I Women with estrogen N = 100 • Part A: AZD8835 single agent dose escalation
Slide 83: AZD9150 (STAT3)
Lifecycle management Late-stage development AZD9150 (STAT3) Early development - IMED Early development - MedImmune Solid and Haematological Cancers Study phase Patient population Number of patients Design Endpoints Status Phase Ib/II SCCHN N = 147 Dose Escalation advanced solid and haematological
Slide 84: AZD0156 (ATM)
Lifecycle management Late-stage development AZD0156 (ATM) Early development - IMED Early development - MedImmune Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase I Solid tumours N = 90 • Arm 1: AZD0156 + olaparib • Safety, tolerability, pharmacokinetic
Slide 85: AZD2811 (AURN)
Lifecycle management Late-stage development AZD2811 (AURN) Early development - IMED Early development - MedImmune Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase I Solid tumours N = 72 • Arm 1: AZD2811 dose escalation • Safety and tolerability • FPD:
Slide 86: ATM AVI Infections
Lifecycle management Late-stage development ATM AVI Early development - IMED Early development - MedImmune Infections Study phase Patient population Number of patients Design Endpoints Status Phase I Healthy volunteers • Randomized, double-blind, 3-part study in healthy young and • Safety/toler
Slide 87: AZD8108 (NMDA)
Lifecycle management Late-stage development AZD8108 (NMDA) Early development - IMED Early development - MedImmune Phase I clinical development programme Study phase Patient population Number of patients Design Endpoints Status Phase I Healthy volunteers N = 40 • Randomized, double-blind, placebo
Slide 88: AZD3241 (MPO) Multiple System Atrophy
Lifecycle management Late-stage development AZD3241 (MPO) Early development - IMED Early development - MedImmune Multiple System Atrophy Study phase Patient population Number of patients Design Endpoints Status Phase II Parkinson’s disease patients N = 24 • Arm 1: AZD3241 600 mg BID for 8 weeks •
Slide 89: Early development - MedImmune
MedImmune Early development - MedImmune
Slide 90: MEDI7836 (IL-13 mAb) Asthma
Lifecycle management Late-stage development MEDI7836 (IL-13 mAb) Early development - IMED Early development - MedImmune Asthma Study phase Patient population Number of patients Design Endpoints Status Phase I Healthy volunteers N = 32 • Arm 1: 30 mg MEDI7836 (n = 6) or placebo (n = 2) as a singl
Slide 91: MEDI9929 (TSLP mAb) Asthma
Lifecycle management Late-stage development MEDI9929 (TSLP mAb) Early development - IMED Early development - MedImmune Asthma Study phase Patient population Design Endpoints Status Phase II Adult subjects with inadequately • Arm 1: Placebo • Reduction in the annualized asthma • FPD: Q2 14 PATHWAY
Slide 92: MEDI5872 (B7RP-1 mAb) SLE
Lifecycle management Late-stage development MEDI5872 (B7RP-1 mAb) Early development - IMED Early development - MedImmune Systemic Lupus Erythematosus (SLE) Study phase Patient population Number of patients Design Endpoints Status Phase IIa Primary Sjögren's syndrome N = 42 • Arm 1: MEDI5872 210
Slide 93: Mavrilimumab (GMCSF mAb) Rheumatoid arthritis
Lifecycle management Late-stage development Mavrilimumab (GMCSF mAb) Early development - IMED Early development - MedImmune Rheumatoid arthritis (RA) Study phase Patient population Number of patients Design Endpoints Status Phase II RA patients who have failed 1 N = 138 • Arm 1: Mavrilimumab SC •
Slide 94: Other biologics Inflammation
Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Inflammation Compound Study phase Patient population Number of patients Design Endpoints Status Anti-α4β7 mAb Phase II Moderate to severe N = 359 • Arm 1: MEDI7183 dose level 1, S C
Slide 95: Other biologics Autoimmunity
Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Autoimmunity Compound Study phase Patient population Number of patients Design Endpoints Status Anti-CD19 mAb Phase II/III Adults with N = 212 (est.) • Arm 1: MEDI-551500mg IV • Pr
Slide 96: Other biologics Cardiovascular & metabolic disease
Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Cardiovascular & metabolic disease Compound Study phase Patient population Number of patients Design Endpoints Status rhLCAT Phase IIa Adults with stable N = 56 • SAD in stable coron
Slide 97: Durvalumab + Iressa (gefitinib) NSCLC
Lifecycle management Late-stage development Durvalumab (MEDI4736;; PD-L1 mAb) Early development - IMED Early development - MedImmune + Iressa (gefitinib) Non-small cell lung cancer (NSCLC) Study phase Patient population Number of patients Design Endpoints Status Phase I NSCLC N = 36 Escalation
Slide 98: Other biologics Immuno-oncology
Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Immuno-oncology Compound Study phase Patient population Number of patients Design Endpoints Status PD-L1 (durvalumab, Phase I/II Solid tumours N = 1,038 • Dose Escalation: 5 cohort
Slide 99: Durvalumab + Tafinlar/Mekinist Melanoma
Lifecycle management Late-stage development Durvalumab (MEDI4736;; PD-L1 mAb) + Tafinlar Early development - IMED Early development - MedImmune (dabrafenib)/ Mekinist (trametinib) Melanoma Study phase Patient population Number of patients Design Endpoints Status Phase I/II Metastatic or unresect
Slide 100: Durvalumab + tremelimumab Solid tumours
Lifecycle management Late-stage development Durvalumab (MEDI4736;; PD-L1 mAb) Early development - IMED Early development - MedImmune + tremelimumab (CTLA-4 mAb) Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase Ib/II Gastric or GEJ N = 174 • Arm A: du
Slide 101: MEDI0562 (OX40 mAb) Advanced malignancies
Lifecycle management Late-stage development MEDI0562 (OX40 mAb) Early development - IMED Early development - MedImmune Advanced malignancies Study phase Patient population Number of patients Design Endpoints Status Phase I Advanced malignancies N = 50 Dose-escalation phase • Safety • FPD: Q1 15
Slide 102: MEDI6383 + durvalumab Advanced malignancies
Lifecycle management Late-stage development MEDI6383 (OX40 fusion protein) + durvalumab Early development - IMED Early development - MedImmune (MEDI4736;; PD-L1 mAb) Advanced malignancies Study phase Patient population Number of patients Design Endpoints Status Phase I Advanced malignancies N =
Slide 103: MEDI0680 (PD-1 mAb) + durvalumab
Lifecycle management Late-stage development MEDI0680 (PD-1 mAb) + durvalumab (MEDI4736) Early development - IMED Early development - MedImmune Advanced malignancies Study phase Patient population Number of patients Design Endpoints Status Phase I Advanced malignancies N = 150 Dose-escalation ph
Slide 104: MEDI9447 (CD73 mAb) + Durvalumab
Lifecycle management Late-stage development MEDI9447 (CD73 mAb) + Durvalumab Early development - IMED Early development - MedImmune (MEDI4736;; PD-L1 mAb) Advanced malignancies Study phase Patient population Number of patients Design Endpoints Status Phase I Advanced malignancies N = 132 Dose-e
Slide 105: MEDI1873 (GITR agonist) Solid tumours
Lifecycle management Late-stage development MEDI1873 (GITR agonist) Early development - IMED Early development - MedImmune Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase I Adult subjects with select N = 42 Dose-escalation phase • Safety • FPD: Q4 15
Slide 106: MEDI9197 (TLR7/8 agonist) Solid tumours
Lifecycle management Late-stage development MEDI9197 (TLR7/8 agonist) Early development - IMED Early development - MedImmune Solid tumours Study phase Patient population Number of patients Design Endpoints Status Phase I Advanced solid tumour N = 45 Dose-escalation phase • Safety • FPD: Q4 15 ma
Slide 107: MEDI4276 (HER2 ADC mAb) Advanced malignancies
Lifecycle management Late-stage development MEDI4276 (HER2 ADC mAb) Early development - IMED Early development - MedImmune Advanced malignancies Study phase Patient population Number of patients Design Endpoints Status Phase I Advanced HER2+ metastatic Dose escalation • First –time-in-human Pha
Slide 108: MEDI-551 (CD19 mAb) Haematological malignancies
Lifecycle management Late-stage development MEDI-551 (CD19 mAb) Early development - IMED Early development - MedImmune Haematological malignancies Study phase Patient population Number of patients Design Endpoints Status Phase II Adults with relapsed or N = 170 • Arm 1: MEDI-551 dose level 1 an
Slide 109: Other biologics Solid tumours
Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Solid tumours Compound Study phase Patient population Number of patients Design Endpoints Status Anti-IGF ligand mAb Phase I/II Patients with HR+ N = 176 • Arm 1: MEDI-573 IV and A
Slide 110: Other biologics Solid tumours
Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Solid tumours Compound Study phase Patient population Number of patients Design Endpoints Status Anti-CEA BiTE mAb Phase I Adults with N = 51 max • Dose-escalation (3+3), IV • MTD
Slide 111: Other biologics Infections
Lifecycle management Late-stage development Other biologics Early development - IMED Early development - MedImmune Infections Compound Study phase Patient population Number of patients Design Endpoints Status Anti-Staph AT Phase II Intubated ICU N = 462 • Placebo-controlled, single-dose, dose-
Slide 112: Vaccine biologics Influenza vaccines
Lifecycle management Late-stage development Vaccine biologics Early development - IMED Early development - MedImmune Influenza vaccines Compound Study phase Patient population Number of patients Design Endpoints Status MEDI3250 Phase III Children 2 to 6 years of N = 100 • Open-label • Safety and
Slide 113: MEDI1814 (amyloid beta mAb) Alzheimer's disease
Lifecycle management Late-stage development MEDI1814 (amyloid beta mAb) Early development - IMED Early development - MedImmune Alzheimer’s disease Study phase Patient population Number of patients Design Endpoints Status Phase I Alzheimer’s disease & healthy N = 121 • SAD & MAD • Safety, tolerabi
Slide 114: Clinical Trials Appendix Q4 2015 Update
Clinical Trials Appendix Q4 2015 Update