Slide 1: Clinical trials appendix Q1 2017 Results update
Clinical trials appendix Q1 2017 Results update
Slide 2: Information about AstraZeneca clinical trials 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 31 March 2016,
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
Slide 4: Table of contents
Table of contents slide Early development - IMED Movement since Q4 2016 update Oncology Q1 2017 New Molecular Entity (NME) Pipeline CVMD Q1 2017 Lifecycle Management (LCM) Pipeline Respiratory Other Approved medicines Oncology CVMD Early development - MedImmune Respiratory Oncology CVMD Respiratory
Slide 5: Movement since Q4 2016 update
Movement since Q4 2016 update New to Phase I New to Phase II New to Pivotal Study New to Registration NMEs NMEs Additional indications NME’s MEDI3726# anifrolumab# durvalumab# PEARL benralizumab# [JP]1 PSMA prostate IFNαR SLE SC PD-L1 1L NSCLC IL-5R severe asthma MEDI5083 Lynparza¶+cediranib CONCERT
Slide 6: Q1 2017 New Molecular Entity (NME) Pipeline
Q1 2017 New Molecular Entity (NME)1 Pipeline Phase I Phase II Phase III Applications Under Review 32 New Molecular Entities 25 New Molecular Entities 9 New Molecular Entities 3 New Molecular Entities Small molecule Large molecule Small molecule Large molecule Small molecule Large molecule Small mole
Slide 7: Q1 2017 Lifecycle Management (LCM) Pipeline
Q1 2017 Lifecycle Management (LCM)1 Pipeline Phase I Phase II Phase III Applications Under Review 0 Projects 5 Projects 21 Projects 5 Projects Small molecule Large molecule Small molecule Large molecule Small molecule Large molecule Small molecule Large molecule Brilinta/Brilique HESTIA durvalumab#
Slide 8: Approved medicines
AstraZeneca Approved medicines
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
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
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
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 +
Slide 13: 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
Slide 14: 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
Slide 15: 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
Slide 16: 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
Slide 17: 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:
Slide 18: 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
Slide 19: 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
Slide 20: 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 •
Slide 21: 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: Aclidinium bromide 400μg • Prim
Slide 22: Duaklir COPD
Approved medicines Oncology Late-stage development Duaklir (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: Aclidinium/formoterol F
Slide 23: Duaklir COPD
Approved medicines Oncology Late-stage development Duaklir (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: Aclidinium/formoterol FD
Slide 24: 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
Slide 25: 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
Slide 26: 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
Slide 27: 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
Slide 28: Late-stage pipeline
AstraZeneca Late-stage pipeline
Slide 29: Durvalumab non-small cell lung cancer
Approved medicines Oncology Late-stage development 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: Durvalumab mg/kg IV Q4W x 12m •
Slide 30: Durvalumab head & neck and other solid tumours
Approved medicines Oncology Late-stage development 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 Escalati
Slide 31: Durvalumab + tremelimumab solid tumours
Approved medicines Oncology Late-stage development 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: durvalumab + tremelimumab (P
Slide 32: Durvalumab + tremelimumab solid tumours
Approved medicines Oncology Late-stage development 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 Advanced Solid
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
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
Slide 35: 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 78 • Arm A: pembrolizumab • ORR • FPCD: Q2 2015 ACE-ST-0
Slide 36: 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.
Slide 37: 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 •
Slide 38: 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
Slide 39: 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
Slide 40: 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:
Slide 41: ZS-9 hyperkalemia
Approved medicines Oncology Late-stage development ZS-9 (Sodium zirconium cyclosilicate) Early development - IMED Early development - MedImmune Hyperkalemia Trial Population Patients Design Endpoints Status CVMD Phase II Hyperkalemia and moderate 90 • Arm 1: Escalating TID doses (0.3g, 3g and 10g) o
Slide 42: 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
Slide 43: 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
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 asthma 230 • Arm 1: 30mg Q4W SC • Primary endpoint: Onset and • FPCD:
Slide 45: 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
Slide 46: 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
Slide 47: 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
Slide 48: 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 •
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 I Healthy subjects 60 • Arm 1: BGF MDI 320/14.4/9.6μg • O
Slide 50: 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 MEDI-546 Q4
Slide 51: 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
Slide 52: 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: AZD3293 20mg once daily • Pri
Slide 53: 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
Slide 54: Early development - IMED
AstraZeneca Early development - IMED
Slide 55: 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
Slide 56: 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 p53 mutant PSR ovarian 136 • Arm 1: C
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 ER+ metastatic breast 316 • Arm 1: Fasl
Slide 58: 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
Slide 59: 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
Slide 60: 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
Slide 61: 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
Slide 62: 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 st 1 treatment wi
Slide 63: Savolitinib (AZD6094) (MET)
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 II Papillary renal cell cancer 109 • Single arm trial: savolitinib
Slide 64: 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
Slide 65: 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
Slide 66: 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
Slide 67: 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
Slide 68: 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
Slide 69: 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 SMAD trial (one trial site in Germany) • Safety and tolerability • FPCD:
Slide 70: 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
Slide 71: 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
Slide 72: 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
Slide 73: 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
Slide 74: 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
Slide 75: AZD7594 asthma/COPD
Approved medicines Oncology Late-stage development AZD7594 (inhaled SGRM) Early development - IMED Early development - MedImmune Asthma/Chronic Obstructive Pulmonary Disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase II Patients with mild to moderate 48 A randomised, double
Slide 76: AZD7594 asthma/COPD
Approved medicines Oncology Late-stage development AZD7594 (inhaled SGRM) Early development - IMED Early development - MedImmune Asthma/Chronic Obstructive Pulmonary Disease (COPD) Trial Population Patients Design Endpoints Status CVMD Phase I Healthy subjects 18 A Randomized Open Label Three-Way Cr
Slide 77: 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
Slide 78: 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
Slide 79: 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
Slide 80: Verinurad gout and hyperuricemia programme
Approved medicines Oncology Late-stage development Verinurad (RDEA3170 - SURI, URAT1 inhibitor) Early development - IMED Early development - MedImmune Gout and hyperuricemia development programme Trial Population Patients Design Endpoints Status CVMD Phase II Combination therapy trial with 60 • Arm
Slide 81: 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
Slide 82: 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
Slide 83: Early development - MedImmune
MedImmune Early development - MedImmune
Slide 84: Durvalumab immuno-oncology
Approved medicines Oncology Late-stage development Durvalumab (PD-L1 mAb) Early development - IMED Early development - MedImmune Immuno-oncology Trial Compound Population Patients Design Endpoints Status CVMD Phase I/II Durvalumab Solid tumours 1,014 • Dose Escalation: 5 cohorts at Q2W and 1 cohort
Slide 85: Durvalumab + tremelimumab solid and hematologic tumours
Approved medicines Oncology Late-stage development 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: durvalumab + treme
Slide 86: Durvalumab + Iressa NSCLC
Approved medicines Oncology Late-stage development 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 36 Escalation phase Primary endpoints: • FPCD:
Slide 87: Durvalumab + MEDI0680 advanced cancers
Approved medicines Oncology Late-stage development 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 endpoints: •
Slide 88: Durvalumab + dabrafenib/trametinib melanoma
Approved medicines Oncology Late-stage development 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 69 Dose Es
Slide 89: Durvalumab + monalizumab advanced solid tumours
Approved medicines Oncology Late-stage development 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 Primary endpoin
Slide 90: MEDI0562 (OX40 mAb) advanced cancers
Approved medicines Oncology Late-stage development MEDI0562 (OX40 mAb) Early development - IMED Early development - MedImmune MEDI0562 (OX40 mAb) + durvalumab (PD-L1 mAb) or tremelimumab (CTLA-4 mAb) CVMD Advanced cancers Trial Population Patients Design Endpoints Status Phase I Advanced malignancie
Slide 91: 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
Slide 92: 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
Slide 93: MEDI5083 + durvalumab advanced solid tumours
Approved medicines Oncology Late-stage development MEDI5083 + 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 endpoints: • FPCD
Slide 94: 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
Slide 95: MEDI9447 (CD73 mAb) + durvalumab
Approved medicines Oncology Late-stage development MEDI9447 (CD73 mAb) + durvalumab Early development - IMED Early development - MedImmune (PD-L1 mAb) Advanced cancers CVMD Trial Population Patients Design Endpoints Status Phase I Advanced malignancies 188 Dose-escalation phase Primary endpoints: •
Slide 96: 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
Slide 97: 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
Slide 98: Tezepelumab (MEDI9929) 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
Slide 99: 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
Slide 100: 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 40 Single Ascending Dose • Safety an
Slide 101: 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
Slide 102: MEDI5872 - AMG 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
Slide 103: MEDI7352 osteoarthritis pain
Approved medicines Oncology Late-stage development MEDI7352 (NGF TNF Bispecific) Early development - IMED Early development - MedImmune Osteoarthritis pain Trial Compound Population Patients Design Endpoints Status CVMD Phase I MEDI7352 (NGF Painful 160 • SAD & MAD • Safety, tolerability, PK, PD • F
Slide 104: 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
Slide 105: 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: MEDI-551 500mg IV • Primary: Time to a
Slide 106: 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
Slide 107: 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
Slide 108: Clinical trials appendix Q1 2017 Results update
Clinical trials appendix Q1 2017 Results update