Slide 1: Clinical Trials Appendix Q1 2015 Results Update
Clinical Trials Appendix Q1 2015 Results Update 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 knowl
Slide 2: Movement since YE 2014 update
Movement since YE 2014 update New to Phase I New to Phase II New to Pivotal Study New to Registration NMEs NMEs AZD7986 ATM AVI# DPP1 COPD targeted serious bacterial infection MEDI0382 MEDI-551# GLP-1/glucagon diabetes/obesity CD19 neuromyelitis optica MEDI0562# MEDI8897# hOX40 agonist solid tumours
Slide 3: Q1 2015 NME Pipeline – External View
Q1 2015 NME† Pipeline – External View RIA CVMD Oncology Infection Neuroscience Terminations in Q1 2015 AZD2115 (COPD) in P2, brodalumab (asthma) in P2, MEDI-559 (RSV prophylaxis) in P1 Divestitures in Q1 2015 AZD0914 (infection) in P2 † Includes significant fixed dose combination projects, and paral
Slide 4: Q1 2015 LCM Pipeline – External View
Q1 2015 LCM† Pipeline – External View RIA CVMD Oncology Infection Neuroscience Gastrointestinal † Includes significant LCM projects and parallel indications for assets in P3 or beyond. Excludes LCM projects already launched in a major market # Partnered; ¶ Registrational P2/3 study; Ɣ MedImmune-spon
Slide 5: 14-16 NME & LE submissions 2015-2016
2015-2016: 14-16 NME & LE submissions MEDI4736 + tremelimumab 2L SCCHN Faslodex MEDI4736 1L metastatic breast 2L SCCHN cancer Lynparza LE submission Brilinta BRCAm metastatic opportunities stroke breast cancer Lynparza saxa/dapa FDC brodalumab* BRCAm PSR type 2 diabetes psoriatic arthritis ovarian
Slide 6: Clinical trials – Approved medicines
AstraZeneca Clinical trials – Approved medicines Q1 2015 Results Update
Slide 7: Symbicort (ICS/LABA)
Symbicort (ICS/LABA) Mild asthma development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Patients in need of GINA Phase III N = 3750 • ARM 1: Symbicort Turbuhaler 160/4.5 μg • Well controlled asthma weeks • FPD: Q4 14 step 2 treatment SYGMA1 'as needed' + Placebo
Slide 8: Eklira (LAMA)
Eklira (LAMA) COPD development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Patients with COPD Phase IV N = 224 • ARM 1: aclidinium bromide 400 μg • Change from baseline in Overall E-RS Total • FPD: Q1 15 • ARM 2: Placebo to aclidinium bromide 400 μg score (i.e. s
Slide 9: Epanova (prescription grade Omega-3 free fatty acid EPA+DHA)
Epanova (prescription grade Omega-3 free fatty acid EPA+DHA) Hypertriglyceridaemia development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Severe hyper- Phase III N = 162 • ARM 1: Epanova 2g QD • Change in serum triglycerides over 12 • FPD: Q4 13 triglyceridaemia
Slide 10: Epanova (prescription grade Omega-3 free fatty acid EPA+DHA)
Epanova (prescription grade Omega-3 free fatty acid EPA+DHA) Hypertriglyceridaemia development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Type 2 DiM Phase II N = 100 • ARM 1: Epanova 4g QD • Reduction in liver fat content (%) at the • FPD: Q1 15 Liver fat >5.5%
Slide 11: Onglyza (DPP-IV inhibitor)
Onglyza (DPP-IV inhibitor) Type 2 Diabetes development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Type 2 diabetes mellitus Phase III N = 444 • ARM 1: Onglyza 5 mg QD +insulin or Primary: • FPD: Q3 14 Onglyza 5 mg QD+ insulin + Met • Change from baseline in HbA1C
Slide 12: Farxiga/Forxiga (SGLT-2 inhibitor)
Farxiga/Forxiga (SGLT-2 inhibitor) Diabetes development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Type 2 diabetes Phase III/IV N = 17150 • ARM 1: Forxiga 10 mg QD + standard of • Time to first event included in the • FPD: Q2 13 mellitus with high DECLARE care t
Slide 13: Farxiga/Forxiga (SGLT-2 inhibitor)
Farxiga/Forxiga (SGLT-2 inhibitor) Diabetes development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Asian subjects with type Phase III N = 260 ARM 1: Forxiga 10 mg QD for 24 weeks + • Change from baseline in HbA1c at • FPD: Q1 14 2 diabetes who have background In
Slide 14: Saxagliptin/dapagliflozin (DPP-4/SGLT-2 inhibitors)
Saxagliptin/dapagliflozin (DPP-4/SGLT-2 inhibitors) FDC Type 2 Diabetes development programme Patient Population Phase # of Design Endpoint(s) Status* Study patients Type 2 diabetes mellitus Phase III N = 280 • ARM 1: Saxa 5mg + Dapa 10 mg + Met Primary: • FPD: Q4 12 IR • Mean change from baseline i
Slide 15: Bydureon (GLP-1 receptor antagonist)
Bydureon (GLP-1 receptor antagonist) Type 2 Diabetes development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Type 2 diabetes Phase III N = 375 • ARM 1: Bydureon BiD SC (autoinjector) • Change in HbA1c from baseline at 28 • FPD: Q1 13 DURATION-NEO 1 • ARM 2: Bydur
Slide 16: Bydureon (GLP-1 receptor antagonist)
Bydureon (GLP-1 receptor antagonist) Type 2 Diabetes development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Type 2 diabetes Phase IV N = 14000 • ARM 1: Bydureon once weekly 2mg SC • Time to first confirmed CV • FPD: Q2 10 EXSCEL • ARM 2: Placebo event in the pri
Slide 17: Brilinta/Brilique (ADP receptor antagonist)
Brilinta/Brilique (ADP receptor antagonist) PARTHENON development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Patients with prior MI Phase III N = 21,000 • ARM 1: Ticagrelor 90 mg BiD • Composite of CV death, non-fatal MI and • FPD: Q4 10 PEGASUS • ARM 2: Ticagre
Slide 18: Faslodex (oestrogen receptor antagonist)
Faslodex (oestrogen receptor antagonist) Breast cancer development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Postmenopausal women Phase III N ~450 • ARM 1: Faslodex 500 mg monthly IM + an • Progression Free Survival (PFS) • FPD: Q4 12 with HR+ locally FALCON ad
Slide 19: Caprelsa
Caprelsa Thyroid cancer development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Differentiated thyroid Phase III N = 227 • ARM 1: Vandetanib 300 mg oral dose QD • Progression Free Survival • FPD: Q3 13 cancer refractory or • LSI: Q4 14 unsuitable for NCT01876784
Slide 20: Lynparza (PARP inhibitor)
Lynparza (PARP inhibitor) Solid tumours development programmes Patient Population Phase # of Design Primary Status Study patients Endpoint PSR BRCAm ovarian Phase III N = 264 • ARM 1: Lynparza tablets 300 mg BiD as maintenance • Progression Free Survival • FPD: Q3 13 cancer SOLO-2 therapy until prog
Slide 21: Lynparza (PARP inhibitor)
Lynparza (PARP inhibitor) Solid tumours development programmes Patient Population Phase # of Design Primary Status Study patients Endpoint BRCAm metastatic Phase III N = 310 • ARM 1: Lynparza 300 mg BiD, continuous to • Progression Free Survival • FPD: Q2 14 breast cancer OlympiAD progression • Seco
Slide 22: Zinforo
Zinforo Serious infections development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Patients with Phase III N = 765 • ARM 1: Ceftaroline fosamil 600 mg q 8 hrs • NI in Clinical Cure rate at the Test of Cure (TOC) • FPD: Q2 12 complicated skin and COVERS (801 actua
Slide 23: Gastrointestinal
Gastrointestinal Compound Patient Population Phase # of Design Endpoint(s) Status Study patients Nexium Refractory RE Phase III N = 280 • ARM 1: Nexium 20 mg BiD • Healing of refractory RE • FPD: Q3 12 ROSE • ARM 2: Nexium 20 mg QD • LSI: Q1 14 • Completion date: Q2 14 NCT01669811 Japan-only study •
Slide 24: Late stage development programmes
AstraZeneca Late stage development programmes Q1 2015 Results Update
Slide 25: Lesinurad (SURI, URAT 1 inhibitor)
Lesinurad (SURI, URAT 1 inhibitor) Gout development programme Patient Population Phase # of Design Primary endpoint Status Study patients Gout with inadequate Phase III N = 600 • ARM 1: Placebo • Proportion of subjects with an sUA level • FPD: Q1 12 hypouricemic response CLEAR 1 • ARM 2: lesinurad 2
Slide 26: Anti-IL-17RA (brodalumab)
Anti-IL-17RA (brodalumab) Psoriasis & psoriatic arthritis development programmes Patient Population Phase # of Design Endpoint(s) Status Study patients Moderate to severe Phase III N = 661 • ARM 1: 210 mg brodalumab SC • PASI at wk 12 • Completed plaque psoriasis AMAGINE-1 • ARM 2: 140 mg brodalumab
Slide 27: LABA/LAMA (PT003) & LAMA (PT001)
LABA/LAMA (PT003) & LAMA (PT001) COPD development programme Patient Population Phase # of Design Endpoint(s) Status Study patients G = Glycopyrronium, F = Formoterol fumarate Moderate to very severe Phase III N = 2103 Treatment (24-week Treatment Period) • Change from baseline in • FPD: Q2 13 COPD (
Slide 28: LABA/LAMA (PT003) & LAMA (PT001)
LABA/LAMA (PT003) & LAMA (PT001) COPD development programme continued Patient Population Phase # of Design Endpoint(s) Status Study patients G = Glycopyrronium, F = Formoterol fumarate Moderate to severe Phase IIIb N = 150 Treatment ( 5- to 6- week Treatment Period) Percentage of devices where numbe
Slide 29: Anti-IL-5R (benralizumab)
Anti-IL-5R (benralizumab) Asthma development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Severe asthma, Phase III N = 1026 HD + • ARM 1: 30 mg Q8w SC • Annual asthma exacerbation rate • FPD: Q4 13 inadequately controlled CALIMA ~200 MD • ARM 2: 30 mg Q4w SC • As
Slide 30: Anti-IL-5R (benralizumab)
Anti-IL-5R (benralizumab) Asthma development programme (continued) Patient Population Phase # of Design Endpoint(s) Status Study patients Asthmatic with FEV1 (50- Phase III N = 200 • ARM 1: 30 mg Q4w SC • Pulmonary function (FEV1) • FPD: Q1 15 90% predicted) on low to BISE • ARM 3: Placebo SC • Est
Slide 31: Anti-IL-5R (benralizumab)
Anti-IL-5R (benralizumab) COPD development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Moderate to very severe Phase III N = 2088 • ARM 1: 10 mg Q8w SC • Rate of COPD exacerbation • FPD: Q3 14 Chronic Obstructive TERRANOVA • ARM 2: 30 mg Q4w SC Pulmonary Disease
Slide 32: Tralokinumab (anti-IL-13)
Tralokinumab (anti-IL-13) Asthma development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Adults with uncontrolled Phase III N = 1140 Cohort 1: Primary endpoint: • FPD: Q3 14 severe asthma STRATOS 1 • ARM 1: Tralokinumab dose regimen 1, SC • Annual asthma exacerba
Slide 33: Roxadustat (HIF-PHI)
Roxadustat (HIF-PHI) Phase III CKD programme Patient Population Phase Study # of patients Design Endpoint(s) Status Anaemia in Chronic Phase III ANDES N = 600 • ARM 1: Roxadustat • Haemoglobin response • Sponsored by FibroGen Kidney Disease patients • ARM 2: Placebo • FPD: Q4 12 not receiving NCT017
Slide 34: AZD9291 (Highly selective, irreversible EGFR TKI)
AZD9291 (Highly selective, irreversible EGFR TKI) NSCLC development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Advanced EGFRm NSCLC TKI failure + /- primary • FPD: Q1 13 Phase I/II • Safety and tolerability resistance mutation T790M • Enrolment complete (N=201 i
Slide 35: Selumetinib (AZD6244, ARRY142886) (MEK-inhibitor)
Selumetinib (AZD6244, ARRY142886) (MEK-inhibitor) Solid tumours development programmes Patient Population Phase # of Design Endpoint(s) Status Study patients 2L KRASm positive Phase III N = 634 • ARM 1: Selumetinib 75mg BiD + docetaxel 75 mg/m2 IV on day • Progression Free Survival • FPD: Q4 13 NSCL
Slide 36: Selumetinib (AZD6244, ARRY142886) (MEK-inhibitor)
Selumetinib (AZD6244, ARRY142886) (MEK-inhibitor) Solid tumours development programmes Patient Population Phase # of Design Endpoint(s) Status Study patients 2L KRASm negative Phase II N = 265 • ARM 1: Selumetinib 75mg BiD + docetaxel 75 mg/m2 IV on day 1 • Progression Free Survival • FPD: Q1 13 NSC
Slide 37: Anti-PD-L1 (MEDI4736)
Anti-PD-L1 (MEDI4736) Solid tumours development programmes Patient Population Phase # of Design Endpoint(s) Status Study patients Stage IIIB-IV NSCLC Phase II N = 188 • Cohort 1: MEDI4736 IV Q2W (EFGR/ALK WT) • Objective Response Rate • FPD: Q1 14 patients ATLANTIC • Cohort 2: MEDI4736 IV Q2W (EFGR/
Slide 38: Anti-PD-L1 (MEDI4736) continued…
Anti-PD-L1 (MEDI4736) continued… Solid tumours development programmes Patient Population Phase # of patients Design Endpoint(s) Status Study Stage IV squamous Phase II/III Lung N = 400 (4736 Umbrella study with 5 substudies based on biomarker Overall Master Protocol (co- • FPD: Q3 14 NSCLC patients
Slide 39: Anti-PD-L1 (MEDI4736) continued…
Anti-PD-L1 (MEDI4736) continued… Solid tumours development programmes Patient Population Phase # of Design Endpoint(s) Status Study patients Solid tumors (treme Phase 1 N=22 • Tremelimumab + MEDI4736 • Safety • FPD: Q2 14 Phase I) combination in • Dose Escalation study • Optimal biologic dose • LSI:
Slide 40: Anti-PD-L1 (MEDI4736) continued…
Anti-PD-L1 (MEDI4736) continued… Solid tumours development programmes Patient Population Phase # of Design Endpoint(s) Status Study patients Solid tumours Phase I N= 108 • Dose Escalation: N=36, 3 cohorts receiving • Safety and Tolerability • FPD: Q4 14 Treatment A (mogamulizumab+MEDI4736) and 3 • M
Slide 41: Anti-CTLA-4 (tremelimumab)
Anti-CTLA-4 (tremelimumab) Mesothelioma development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Patients with unresectable Phase II N = 564 • ARM 1: Tremelimumab IV • Overall survival (OS) • FPD: Q2 13 pleural or peritoneal • ARM 2: Placebo • LSI: Q4 14 malignant
Slide 42: CAZ-AVI (BLI/cephalosporin SBI)
CAZ-AVI (BLI/cephalosporin SBI) Serious infections development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Hospitalised patients with Phase III N = 493 • ARM 1: CAZ-AVI 2000/500mg plus Metronidazole IV • Co primary of: • FPD: Q1 12 complicated intra- RECLAIM-1 •
Slide 43: CAZ-AVI (BLI/cephalosporin SBI)
CAZ-AVI (BLI/cephalosporin SBI) Serious infections development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Patients with complicated Phase III N = 345 • ARM 1: CAZ-AVI 2000/500mg plus • Patients with clinical cure at the Test • FPD: Q1 13 urinary tract infections
Slide 44: BACE (AZD3293)
BACE (AZD3293) Alzheimer’s Disease development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Alzheimer’s disease Phase II/III N = 2202 • ARM 1: AZD3293 20 mg once daily • Change in Clinical Dementia Rating Sum of • FPD: Q4 14 patients AMARANTH • ARM 2: AZD3293 50 m
Slide 45: Early development programmes
AstraZeneca Early development programmes Q1 2015 Results Update
Slide 46: LABA/LAMA/ICS (PT010)
LABA/LAMA/ICS (PT010) COPD & Asthma development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Moderate to severe COPD Phase II N = 180 • ARM 1: BFF MDI 320/9.6 μg BiD • Forced expiratory volume in 1 • FPD: Q2 14 (BFF dose- • ARM 2: BFF MDI 160/9.6 μg BiD second are
Slide 47: LABA/LAMA/ICS (PT010)
LABA/LAMA/ICS (PT010) COPD & Asthma development programme continued Patient Population Phase # of Design Endpoint(s) Status Study patients Japanese healthy Phase I N = 20 Treatment (2-week Treatment Period) • Overall safety • FPD: Q3 14 volunteers (BGF PK in • ARM 1: BGF MDI 320/14.4/9.6 μg • PK par
Slide 48: MABA (AZD2115)
MABA (AZD2115) COPD clinical development programme Patient Population Phase # of Design Endpoint(s) Status Study patients COPD Phase IIa N = 39 • ARM 1: AZD2115, 25 μg (iNeb) • Peak and trough FEV1 • FPD: Q1 12 MISTRAL • ARM 2: AZD2115, 80 μg (iNeb) • Completed • ARM 3: AZD2115, 240 μg (iNeb) • Est.
Slide 49: p38 inhibitor (AZD7624)
p38 inhibitor (AZD7624) COPD development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Healthy subjects Phase I N = 48 SAD • Safety and tolerability following • FPD: Q1 13 • Five different dose levels investigated vs placebo inhaled administration with • Completed
Slide 50: DPP1 inhibitor (AZD7986)
DPP1 inhibitor (AZD7986) COPD development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Healthy subjects and Phase I N = up to 152 Part 1 (SAD) • Safety and tolerability and PK • FPD: Q4 14 COPD • Five different dose levels investigated vs placebo following oral ad
Slide 51: RDEA3170 (SURI, URAT 1 inhibitor)
RDEA3170 (SURI, URAT 1 inhibitor) Gout development programme Patient Population Phase Study # of Design Primary endpoint Status patients Monotherapy study in Phase II N = 160 • Arm A: Placebo • Efficacy and Safety at Week 24 • FPD: Q3 13 subjects with gout • Arm B: RDEA3170 5 mg QD • LSI: Q4 13 NCT0
Slide 52: Tenapanor/AZD1722 (NHE3 inhibitor)
Tenapanor/AZD1722 (NHE3 inhibitor) Phase II development programme Patient Population Phase # of Design Endpoint(s) Status Study patients End Stage Renal Disease Phase IIb N = 150 • ARM 1: AZD1722,1 mg BiD • Change in serum phosphate levels • FPD: Q1 14 (ESRD) patients on • ARM 2: AZD1722, 3 mg BiD •
Slide 53: WEE-1 (AZD1775)
WEE-1 (AZD1775) Solid tumours development programme Patient Population Phase # of Design Endpoint(s) Status Study patients p53 mutant PSR ovarian Phase II N = 120 • ARM 1: carbo/paclitaxel + AZD1775 225mg • Progression Free Survival • FPD: Q4 12 cancer • ARM 2: carbo/paclitaxel + placebo • LSI: Q3 1
Slide 54: TORC 1/2 (AZD2014)
TORC 1/2 (AZD2014) Solid tumours development programme Patient Population Phase # of Design Endpoint(s) Status Study patients nd 2 line ER+ metastatic Phase II N = 300 • ARM 1: Fulvestrant • Progression Free Survival • FPD: Q2 14 breast cancer MANTA • ARM 2: Fulvestrant + AZD2014 50mg BD continuous
Slide 55: FGFR (AZD4547)
FGFR (AZD4547) Solid tumours development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Advanced cancer who Phase I N = 33 • Part A: AZD4547 in ascending multiple doses given bd and • Part A: MTD and Recommended • Completed: Q2 13 have failed standard od (c. 30 pati
Slide 56: FGFR (AZD4547) continued
FGFR (AZD4547) continued Solid tumours development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Advanced cancer who Phase I N = 94 • Part A: Ascending oral doses of AZD4547 to define maximum • Part A: MTD and Recommended dose • Completed: Q1 14 have failed standar
Slide 57: ISIS-AR (AZD5312)
ISIS-AR (AZD5312) Solid tumours development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Advanced solid tumours Phase I N = 90 Part A: Dose escalation • Part A: MTD and Recommended • FPD: Q2 14 with androgen receptor • AZD5312 in ascending multiple doses given iv
Slide 58: AKT (AZD5363)
AKT (AZD5363) Solid tumours development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Breast and Phase I N = 20 per arm Monotherapy AZD5363 480mg BD 4 days on 3 days off • Safety and tolerability • FPD: Q3 13 gynaecological cancers • Part C arm 1: Breast with PIK3C
Slide 59: PI3Kα/δ inhibitor (AZD8835)
PI3Kα/δ inhibitor (AZD8835) Solid tumours development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Women with estrogen Phase I N = 100 Part A: AZD8835 single agent dose escalation • MTD and recommended Phase II dose of oral • FPD: Q4 14 receptor positive HER-2 AZD
Slide 60: MET (Savolitinib/AZD6094)
MET (Savolitinib/AZD6094 ) Phase I/II development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Advanced cancer Phase I N = 50 • Dose escalation study • Safety and tolerability • FPD: Q1 12 (all-comers) • LSI: Q3 15 NCT01773018 Conducted in Australia • Est. complet
Slide 61: ATR (AZD6738)
ATR (AZD6738) Solid tumours development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Solid tumours Phase I N = 119 • MAD • Safety and tolerability • FPD: Q4 14 • Efficacy • Est. completion: Q4 16 NCT02264678 North America – 1 site • Est. external presentation: 201
Slide 62: PI3Kb/d (AZD8186)
PI3Kb/d (AZD8186) Solid tumours development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Advanced Phase I N = 96 • Part A: AZD8186 monotherapy in ascending intermittent • Part A: PK, MTD and • FPD: Q2 13 CRPC/SqNSCLC/TNBC doses in 2 schedules Recommended dose and
Slide 63: STAT3 (AZD9150)
STAT3 (AZD9150) Haematological malignancies development Patient programme Population Phase # of Design Endpoint(s) Status Study patients HCC Phase I N = 64 • Dose-escalation and dose-expansion study • Safety and tolerability . • FPD: Q2 13 • IV • Recommended phase II dose and schedule • Est. complet
Slide 64: EGFRM BBB (AZD3759)
EGFRM BBB (AZD3759) Lung cancer with LM and/or brain metastases Patient Population Phase # of Design Endpoint(s) Status Study patients EGFRm+ NSCLC Phase I N = 47 • MAD • Safety and tolerability • FPD: Q4 14 • Expansion in LM patients at RP2D with AZD3759 • Preliminary anti-tumour activity • Est. co
Slide 65: Infection early development
Infection early development Serious infections development programme Compound Patient Population Phase # of Design Endpoint(s) Status Study patients ATM-AVI Healthy volunteers Phase I • Randomised, double-blind, 3-part study in healthy young • Safety/tolerability • FPD Q4 12 (Aztreonam- and elderly
Slide 66: Histamine H3 receptor inverse agonist (AZD5213)
Histamine H3 receptor inverse agonist (AZD5213) Phase II clinical development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Tourette’s Disorder Phase IIa N = 18 • Part 1: • Improvement in Total Tic • FPD: Q4 13 Single blind to determine tolerability and PK in adole
Slide 67: NMDA (AZD8108)
NMDA (AZD8108) Phase I clinical development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Healthy volunteers Phase I N = 40 • Randomized, double-blind, placebo-controlled • Safety and tolerability • FPD: Q4 14 Part 1 SAD 3 dosage-level cohorts Additional endpoints:
Slide 68: NK3 Receptor Antagonist (AZD4901)
NK3 Receptor Antagonist (AZD4901) Phase II clinical development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Polycystic ovary Phase IIa N = 56 • ARM 1: AZD4901 20 mg QD • Change from baseline at day 7 in • Completed: Q4 14 syndrome patients with • ARM 2: AZD4901 2
Slide 69: MedImmune Early development programmes
MedImmune Early development programmes Q1 2015 Results Update
Slide 70: Tralokinumab (anti-IL-13)
Tralokinumab (anti-IL-13) IPF development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Adults with Idiopathic Phase II N = 186 • ARM 1: Tralokinumab high dose 800mg IV • Change from baseline in percent-predicted forced • FPD: Q4 12 Pulmonary Fibrosis • ARM 2: Tral
Slide 71: Tralokinumab (anti-IL-13)
Tralokinumab (anti-IL-13) Atopic Dermatitis development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Adults with atopic Phase II N = 18 • ARM 1: Tralokinumab dose 45mg SC • Change from baseline in SCORAD at week 12 • FPD: Q1 15 dermatitis • ARM 2: Tralokinumab dos
Slide 72: Anti-IL-13 (MEDI7836)
Anti-IL-13 (MEDI7836) Asthma development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Healthy volunteers Phase I N = 32 • Cohort 1: 30 mg MEDI7836 (n = 6) or placebo • Safety and tolerability • FPD: Q1 15 (n = 2) as a single SC dose • LSI: Q3 15 NCT02388347 • • Co
Slide 73: Anti-TSLP (MEDI9929)
Anti-TSLP (MEDI9929) Asthma development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Adult subjects with Phase II N = 552 • ARM 1: Placebo • Reduction in the annualized asthma • FPD: Q2 14 inadequately controlled, PATHWAY • ARM 2: Low dose MEDI9929 70mg SC exacerb
Slide 74: Sifalimumab (anti-interferon α)
Sifalimumab (anti-interferon α) SLE development programme Patient Population Phase # of Design Endpoint(s) Status Study patients SLE, DM or PM patients Phase II N = 260 • 600 mg IV Medi-545 • Evaluate long-term safety and • FPD: Q3 10 tolerability of multiple IV doses of • Topline results: Q1 15 MED
Slide 75: Anifrolumab (anti-type I IFN receptor)
Anifrolumab (anti-type I IFN receptor) SLE development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Moderate-severe SLE Phase ll N = 307 (final) • ARM 1: 300 mg IV MEDI-546 Q4W for 48 weeks • Response in SLE responder • FPD: Q1 12 patients • ARM 2: 1000 mg IV MEDI
Slide 76: Anti-B7RP-1 (MEDI5872)
Anti-B7RP-1 (MEDI5872) SLE development programme Patient Population Phase # of Design Endpoint(s) Status Study patients SLE and lupus related Phase I N = 40 Dose escalation study: • Safety and tolerability • FPD: Q2 12 inflammatory arthritis • ARM 1: MEDI5872 SC • Est. topline results: Q2 16 NCT0168
Slide 77: Mavrilimumab (anti-GMCSF)
Mavrilimumab (anti-GMCSF) RA development programme Patient Population Phase # of Design Endpoint(s) Status Study patients RA patients who have Phase II N = 138 • ARM 1: Mavrilimumab 100mg SC • ACR 20/50/70 at wk 24 • FPD: Q1 13 failed 1 or 2 anti-TNF for EARTH • ARM 2: golimumab 50 mg • DAS28 remiss
Slide 78: Autoimmunity biologics early development
Autoimmunity biologics early development Phase I/II/III clinical development programmes Compound Patient population Phase # of Design Endpoint(s) Status Study patients Anti-CD19 mAb Adults with Phase II/III N = 212 • ARM 1: MEDI-551500mg IV • Primary: Time to • FPD: Q1 15 (MEDI-551) Neuromyelitis •
Slide 79: Cardiovascular biologics early development
Cardiovascular biologics early development Phase I clinical development programme Compound Patient Population Phase # of Design Endpoint(s) Status Study patients rhLCAT (MEDI6012) Adults with stable Phase I N = 16 • SAD IV • Safety • Completed by Alphacore coronary artery • Changes in total HDL dise
Slide 80: Immuno-oncology portfolio
Immuno-oncology portfolio Monotherapy early development programme Compound Patient Population Phase # of Design Endpoint(s) Status Study patients PD-1 Solid tumours Phase Ia N = 78 • Dose escalation (3+3) & expansion study • Safety and tolerability • FPD: Q4 13 (MEDI0680) • Study amended to explore
Slide 81: Anti-PD-L1 (MEDI4736) + Iressa (gefitinib)
Anti-PD-L1 (MEDI4736) + Iressa (gefitinib) NSCLC development programme Patient Population Phase # of Design Endpoint(s) Status Study patients NSCLC Phase I N = 47 Escalation phase • Safety • FPD: Q2 14 (Escalation phase) Standard 3+3 design with 28 days DLT period • Optimal biologic dose for the com
Slide 82: Anti-PD-L1 (MEDI4736) + dabrafenib/trametinib (GSK)
Anti-PD-L1 (MEDI4736) + dabrafenib/trametinib (GSK) Melanoma development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Metastatic or Phase I/II N = 69 Dose Escalation: • Safety • FPD: Q1 14 unresectable melanoma • Cohort A • Optimal biologic dose for the combinatio
Slide 83: Anti-PD-L1 (MEDI4736) + Anti-CTLA-4 (tremelimumab)
Anti-PD-L1 (MEDI4736) + Anti-CTLA-4 (tremelimumab) Solid tumours development programme Patient Population Phase # of Design Endpoint(s) Status Study patients NSCLC Phase Ib N = 301 • Dose Escalation: minimum 5 cohorts exploring various • Safety • FPD: Q4 13 (Immunotx naïve and treme Q4W and MEDI4736
Slide 84: Anti-PD-1 (MEDI0680)+ Anti-PD-L1 (MEDI4736)
Anti-PD-1 (MEDI0680)+ Anti-PD-L1 (MEDI4736) Advanced malignancies development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Advanced malignancies Phase I N = 150 Dose-escalation phase • Safety • FPD: Q2 14 • MEDI4736 IV + MEDI0680 IV • Determination of MTD • LSI: Q
Slide 85: Murine Anti-OX40 (MEDI6469) + combinations
Murine Anti-OX40 (MEDI6469) + combinations Advanced malignancies development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Advanced malignancies Phase I/II N = 212 Dose-escalation phase • Determination of MTD • FPD: Q3 14 • MEDI6469 IV monotherapy • Safety • LSI: Q
Slide 86: OX40 agonist (MEDI6383)
OX40 agonist (MEDI6383) Advanced malignancies development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Advanced malignancies Phase I N = 116 Dose-escalation phase • Safety • FPD: Q3 14 • MEDI6383 IV • Determination of MTD • LSI: Q3 16 NCT02221960 • Est. topline re
Slide 87: OX40 agonist (MEDI0562)
OX40 agonist (MEDI0562) Advanced malignancies development programme Patient Population Phase # of Design Endpoint(s) Status Study patients Advanced malignancies Phase I N = 50 Dose-escalation phase • Safety • FPD: Q1 15 • MEDI0562 IV • Determination of MTD • LSI: Q3 16 NCT02318394 • Est. topline res
Slide 88: Anti-CD19 (MEDI-551)
Anti-CD19 (MEDI-551) Haematological malignancies development programme Patient Population Phase Study # of Design Endpoint(s) Status patients Adults with relapsed or Phase II N = 180 • ARM 1: MEDI-551 IV (dose-level 1) and Bendamustine • ORR, including Complete • FPD: Q1 12 refractory B-cell chronic
Slide 89: Moxetumomab Pasudotox (anti-CD22)
Moxetumomab Pasudotox (anti-CD22) Haematological malignancies development programmes Patient Population Phase # of Design Endpoint(s) Status Study patients Adults with relapsed Phase I N = 49 • Open Label dose escalation study • MTD and efficacy • FPD: Q2 07 refractory HCL • LSI: Q1 14 NCT00586924 •
Slide 90: Oncology biologics early development
Oncology biologics early development Solid tumours development programme Compound Patient Population Phase # of Design Endpoint(s) Status Study patients Anti-Ang2 mAb Solid tumours and Phase I N = 16 • MEDI3617 + bevacizumab dose escalation, • Safety and tolerability • FPD: Q4 10 (MEDI3617) ovarian
Slide 91: Oncology biologics early development
Oncology biologics early development Solid tumours development programme Compound Patient Population Phase # of Design Endpoint(s) Status Study patients Anti-CEA BiTE mAb Adults with Phase I N = 51 max • Dose-escalation (3+3), IV • MTD and safety profile • FPD: Q1 11 (MEDI-565) gastrointestinal (GI)
Slide 92: Infectious diseases biologics early development
Infectious diseases biologics early development Phase I/II clinical development programmes Compound Patient Population Phase # of Design Endpoint(s) Status Study patients Anti-Staph AT Intubated ICU Phase II N = 462 • Placebo-controlled, single-dose, • Efficacy and Safety • FPD: Q4 14 (MEDI4893) dos
Slide 93: Infectious diseases biologics early development
Infectious diseases biologics early development Phase I/II clinical development programmes Compound Patient Population Phase # of Design Endpoint(s) Status Study patients Anti- Healthy adults Phase I N = 56 • Randomized, Double-blind, • Evaluate the Safety, Tolerability, and • FPD: Q3 14 Pseudomonas
Slide 94: Vaccines biologics late development
Vaccines biologics late development Phase I/II clinical development programmes Compound Patient Population Phase # of Design Endpoint(s) Status Study patients MEDI3250 Children 2 to 6 years of Phase III N = 100 • Open-label • Safety and tolerability • FPD: Q4 14 FluMist age • Route of administration
Slide 95: Neuroscience biologics early development
Neuroscience biologics early development Phase I development programmes Compound Patient Population Phase # of Design Endpoint(s) Status Study patients Anti-amyloid beta Alzheimer’s disease & Phase I N = 121 • SAD & MAD • Safety, tolerability • FPD: Q2 14 mAb healthy elderly • Up to 10 iv cohorts ar
Slide 96: Gastrointestinal biologics early development
Gastrointestinal biologics early development Phase I/II development programmes Compound Patient Population Phase # of Design Endpoint(s) Status Study patients Moderate to severe Phase II N = 360 • ARM 1: MEDI7183 dose level 1, SC • Remission at week 8 • FPD: Q4 12 ulcerative colitis • ARM 2: MEDI718
Slide 97: AstraZeneca Clinical Programmes Summary – List of abbreviations
AstraZeneca Clinical Programmes Summary List of abbreviations TOC Test of Cure SC Sub-cutaneous LAMA Long Acting Muscarinic Agonist MITT Modified Intent-To-Treat population IV Intra-venous MTX Methotrexate cMITT Clinical Modified Intent-To-Treat population IM Intra-muscular ASA Acetylsalicylic Acid