Slide 1: Clinical trials appendix Q4 2018 results update
Clinical trials appendix Q4 2018 results update
Slide 2: Clinical trials information notice
The following information about AstraZeneca clinical trials in Phases I-IV has been created with selected information from 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 December 2018, unless
Slide 3: List of abbreviations
List of abbreviations ADA Anti-Drug Antibody ICS Inhaled Corticosteroid pMDI Pressurised Metered Dose Inhaler ADC Antibody-Drug Conjugate IM Intra Muscular PoC Proof of Concept AE Adverse Event IR Immediate Release PR Partial Response AUC Area Under Curve IV Intravenous Q2W Quaque (every) Two Weeks
Slide 4: Table of contents
Table of contents slide Movement since Q3 2018 results announcement Q4 2018 NME pipeline Q4 2018 LCM pipeline Oncology Approved medicines and late-stage development Early-stage development Cardiovascular, Renal & Metabolism (CVRM), Respiratory & Other Approved medicines and late-stage development Ea
Slide 5: Movement since Q3 2018 update
Movement since Q3 2018 update New to Phase I New to Phase II New to Pivotal Study New to Registration NME NME NME MEDI6570 Imfinzi# + oleclumab PT027 LOX-1 mAb cardiovascular disease PD-L1 mAb + CD73 mAb solid tumours ICSC/SABA asthma AZD0449 Imfinzi# + monalizumab# Lifecycle Management Inhales JAK
Slide 6: Q4 2018 New Molecular Entity (NME) pipeline
Q4 2018 New Molecular Entity (NME)1 pipeline Phase I Phase II Phase III Applications Under Review 26 New Molecular Entities 20 New Molecular Entities 11 New Molecular Entities 0 New Molecular Entities AZD0156 Imfinzi#+dabrafenib+trametinib adavosertib#+chemotherapy Imfinzi#+MEDI0680 Imfinzi#+tremeli
Slide 7: Oncology Q4 2018 Lifecycle Management pipeline
Oncology Q4 2018 Lifecycle Management (LCM)1 pipeline Phase I Phase II Phase III Applications Under Review 0 Projects 2 Projects 18 Projects 0 Projects Calquence Calquence# Imfinzi#+CTx NIAGARA BTK haematalogical malignancies BTK inhibitor 1st line MCL PD-L1+CTx muscle invasive bladder cancer Imfinz
Slide 8: CVRM, Respiratory, Other Q4 2018 NME pipeline
Cardiovascular, Renal & Metabolism, Respiratory, Other Q4 2018 New Molecular Entity (NME)1 pipeline Phase I Phase II Phase III Applications Under Review 13 New Molecular Entities 23 New Molecular Entities 3 New Molecular Entities 1 New Molecular Entity AZD0449 abediterol# cotadutide (MEDI0382) PT027
Slide 9: CVRM, Respiratory, Other Q4 2018 Lifecycle Management pipeline
Cardiovascular, Renal & Metabolism, Respiratory, Other Q4 2018 Lifecycle Management (LCM)1 pipeline Phase I Phase II Phase III Applications Under Review 0 Projects 0 Projects 11 Projects 4 Projects Fasenra# Symbicort SYGMA IL-5R COPD as needed in mild asthma Fasenra# OSTRO Farxiga/Forxiga DEPICT IL-
Slide 10: Estimated key regulatory submission acceptances
Estimated key regulatory submission acceptances PT010 COPD (US/EU) Lokelma (JP) PT027 asthma selumetinib SPRINT Fasenra severe asthma (China) Imfinzi + tremelimumab NEPTUNE tezepelumab NAVIGATOR NME Imfinzi + tremelimumab DANUBE Lokelma (CN) Imfinzi + tremelimumab + CRT ADRIATIC roxadustat anaemia i
Slide 11: Designations
Designations 4 Accelerated approvals 8 Breakthrough Therapy 8 Fast Track 20 Priority Review / PRIME 22 Orphan Drug Lynparza ovarian cancer SOLO-2 (US) Tagrisso EGFRm T790M NSCLC (US) MEDI3902 Psl-PcrV pneumo Px (US) Tagrisso EGFRm T790M NSCLC (JP) Lynparza ovarian cancer SOLO-2 (US) Tagrisso EGFRm T
Slide 12: Oncology – approved medicines and late-stage pipeline
AstraZeneca Oncology – approved medicines and late-stage pipeline
Slide 13: Tagrisso trials
Approved medicines Oncology Late-stage development Tagrisso (highly-selective, irreversible EGFRi) Early development Non-small cell lung cancer (NSCLC) Trial Population Patients Design Endpoints Status CVRM Phase III Adjuvant EGFRm 700 • Arm 1: Tagrisso 80mg QD following complete tumour • Primary en
Slide 14: Imfinzi trials: early-use NSCLC
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development Non-small cell lung cancer (NSCLC), early use Trial Population Patients Design Endpoints Status CVRM Phase III Adjuvant NSCLC patients 1,360 • Arm 1: Imfinzi mg/kg IV Q4W x 12m Primary endpoint: • FPCD: Q1 2015
Slide 15: Imfinzi trials: other cancers
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development Other cancers Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 108 • Dose escalation: N=36, three cohorts receiving Treatment A • Safety and tolerability • FPCD: Q4 2014 (mogamulizuma
Slide 16: Imfinzi +/- treme: advanced lung cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development Lung cancer, advanced Trial Population Patients Design Endpoints Status CVRM Phase III Limited disease- Small cell 600 • Arm 1: Imfinzi + tremelimumab (4 doses) Primary endpoints: • FPCD:
Slide 17: Imfinzi +/- treme: other cancers
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development Other cancers Trial Population Patients Design Endpoints Status CVRM Phase III Non-muscle invasive bladder 975 • Arm 1: BCG (Bacillus Calmette–Guérin) (Induction + Primary endpoints: • FPC
Slide 18: Imfinzi +/- treme: other cancers
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development Other cancers Trial Population Patients Design Endpoints Status CVRM Phase III Advanced solid malignancies 1,200 • Arm 1: Imfinzi • Primary endpoint: Safety • FPCD: Q2 2017 STRONG • Arm 2:
Slide 19: Lynparza: ovarian and other cancers
Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development Ovarian and other cancers Trial Population Patients Design Endpoints Status CVRM Phase III BRCAm maintenance ovarian 391 • Arm 1: Lynparza tablets 300mg BID maintenance therapy for • Primary endpoint: PFS
Slide 20: Lynparza: Imfinzi combinations
Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development Imfinzi combinations, cancers Trial Population Patients Design Endpoints Status CVRM Phase III Advanced ovarian cancer 1L 1,056 Non tBRCAm (tumour BRCA) patients Primary endpoint: • FPCD: Q1 2019 • Arm 1:
Slide 21: Lynparza: combinations, cancers
Approved medicines Oncology Late-stage development Lynparza (PARP inhibitor) Early development Combinations, cancers Trial Population Patients Design Endpoints Status CVRM Phase III Advanced ovarian cancer 1L 806 • Arm 1: Lynparza maintenance therapy for two years or until Primary endpoint: • FPCD:
Slide 22: Calquence: blood cancers
Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development Blood cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase III Previously untreated chronic 535 • Arm A: chlorambucil + obinutuzumab • Primary endpoint: PFS (Arm A vs. Arm • FPCD: Q2 2015
Slide 23: Calquence: blood cancers
Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development Blood cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase I/II B-cell Malignancies 126 Dose escalation and expansion trial of the combination of • Safety • FPCD: Q1 2015 ACE-LY-001 Calqu
Slide 24: Calquence: blood cancers
Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development Blood cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase I Japanese Adults with 28 • Calquence monotherapy • Safety • FPCD: Q2 2017 Advanced B-cell Malignancies • Dose confirmation and
Slide 25: Calquence: other cancers
Approved medicines Oncology Late-stage development Calquence (BTK inhibitor) Early development Other cancers Trial Population Patients Design Endpoint(s) Status CVRM Phase II ≥ 2L advanced or metastatic 74 • Arm A: pembrolizumab • ORR • FPCD: Q2 2015 ACE-ST-006 Head and neck squamous-cell • Arm B: C
Slide 26: Lumoxiti: blood cancer
Approved medicines Oncology Late-stage development Lumoxiti (moxetumomab pasudotox,CD22 mAb) Early development Blood cancer Trial Population Patients Design Endpoints Status CVRM Phase III Adults with relapsed or 77 • Multicentre, single-arm, open-label Phase III trial • Primary endpoint: Rate of du
Slide 27: Selumetinib: paediatric neurofibromatosis type 1
Approved medicines Oncology Late-stage development Selumetinib (MEK inhibitor) Early development Paediatric neurofibromatosis type 1 Trial Population Patients Design Endpoints Status CVRM Phase II Paediatric neurofibromatosis 50 (stratum 1) • Single arm: selumetinib 25mg/m2 BID with 2 strata: • Comp
Slide 28: Savolitinib: papillary renal cell and other cancers
Approved medicines Oncology Late-stage development Savolitinib (MET inhibitor) Early development Papillary renal cell and other cancers Trial Population Patients Design Endpoints Status CVRM Phase III MET-Driven, Papillary renal 180 • Arm 1: savolitinib 600mg QD • Primary endpoint: PFS • FPCD: Q4 20
Slide 29: Cediranib: ovarian cancer
Approved medicines Oncology Late-stage development Cediranib (VEGF receptor inhibitor) Early development Ovarian cancer Trial Population Patients Design Endpoints Status CVRM Phase IIb Recurrent platinum resistant 62 • Cediranib 30 mg + Lynparza 200 mg bd • ORR DoR, DCR, QoL. OS; Safety • FPCD: Q1 2
Slide 30: Oncology – early-stage development
AstraZeneca Oncology – early-stage development
Slide 31: AZD0156 (ATM inhibitor)
Approved medicines Oncology Late-stage development AZD0156 (ATM inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 130 • Arm 1: AZD0156 + Lynparza • Safety, tolerability, PK and efficacy • FPCD: Q4 2015 • Arm 2: AZD0156 + irinotecan • Dat
Slide 32: AZD1390 (ATM inhibitor, blood brain barrier)
Approved medicines Oncology Late-stage development AZD1390 (ATM inhibitor, blood brain barrier) Early development Cancer Trial Population Subjects Design Endpoints Status CVRM Phase I Healthy volunteers 8 • Positron-Emission Tomography (PET) trial • Brain distribution of AZD1390 to assess • FPCD: Q4
Slide 33: Adavosertib (AZD1775, WEE-1 inhibitor)
Approved medicines Oncology Late-stage development Adavosertib (AZD1775, WEE-1 inhibitor) Early development Ovarian cancer, triple-negative breast cancer, small cell lung cancer (SCLC) Trial Population Patients Design Endpoints Status CVRM Phase II Platinum-resistant (PR) 97 • Arm B: paclitaxel + ad
Slide 34: Adavosertib (AZD1775, WEE-1 inhibitor)
Approved medicines Oncology Late-stage development Adavosertib (AZD1775, WEE-1 inhibitor) Early development Ovarian cancer, triple-negative breast cancer, small cell lung cancer (SCLC) Trial Population Patients Design Endpoints Status CVRM Phase I Advanced solid tumours 24 Open-label, randomised, 2-
Slide 35: Capivasertib (AZD5363, AKT inhibitor)
Approved medicines Oncology Late-stage development Capivasertib (AZD5363, AKT inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Breast and gynaecological 12-24 per arm (Parts E AZD5363 400mg BD 4 days on 3 days off combined with 500mg • Safety and tol
Slide 36: Imfinzi + dabrafenib / trametinib: melanoma
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) + dabrafenib Early development (BRAF inhibitor) / trametinib (MEK inhibitor) Melanoma CVRM Trial Population Patients Design Endpoints Status Phase I/II Metastatic or unresectable 68 Dose Escalation: Primary endpoints: • FPCD: Q1
Slide 37: Imfinzi: cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development Cancer Trial Compound Population Patients Design Endpoints Status CVRM Phase I/II Imfinzi Solid tumours 1,022 • Dose escalation: 5 cohorts at Q2W and 1 cohort at Q3W • Safety • FPCD: Q3 2012 STUDY 1108 • Dose ex
Slide 38: Imfinzi + tremelimumab: cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development + tremelimumab (CTLA-4 mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase Ib/II Gastric/gastro-Oesophageal 114 • Arm A: Imfinzi + tremelimumab 2L • Primary endpoints: Safety & tolerability,
Slide 39: Imfinzi + monalizumab: cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) + Early development monalizumab (NKG2a mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase I/II Advanced solid tumours 50 Escalation phase Primary endpoints: • FPCD: Q2 2016 • monalizumab + Imfinzi IV • Safet
Slide 40: Imfinzi + MEDI0457: SCCHN
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development + MEDI0457 (DNA HPV Vaccine) Squamous cell carcinoma of the Head and Neck (SCCHN) CVRM Trial Population Patients Design Endpoints Status Phase Ib/IIa Human papillomavirus (HPV) 50 Multi-centre, open label trial
Slide 41: Imfinzi + MEDI0680: cancer
Approved medicines Oncology Late-stage development Imfinzi (PD-L1 mAb) Early development + MEDI0680 (PD-1 mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase I/II Advanced malignancies 97 Dose escalation phase Primary endpoints: • FPCD: Q2 2014 (escalation phase) • Imfinzi IV +
Slide 42: Oleclumab (MEDI9447, CD73 mAb)
Approved medicines Oncology Late-stage development Oleclumab (MEDI9447, CD73 mAb) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced malignancies 310 Dose escalation phase Primary endpoints: • FPCD: Q3 2015 • oleclumab IV • Safety • Data anticipated: 202
Slide 43: AZD2811 (AURN)
Approved medicines Oncology Late-stage development AZD2811 (AURN) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 72 • Arm 1: AZD2811 dose escalation • Safety and tolerability • FPCD: Q4 2015 • Arm 2: AZD2811 dose expansion • Pharmacokinetics and
Slide 44: AZD4547 (FGFR inhibitor)
Approved medicines Oncology Late-stage development AZD4547 (FGFR inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase II Female ER+ breast cancer 40 • Part A: AZD4547 in ascending multiple doses in combination • Part A: MTD of AZD4547 in combination • FPCD
Slide 45: AZD4573 (CDK9 inhibitor)
Approved medicines Oncology Late-stage development AZD4573 (CDK9 inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/refractory 42 Dose escalation in relapsed/refractory haematological Primary: • FPCD: Q4 2017 haematologic malignancies malignan
Slide 46: AZD4635 (A2AR inhibitor)
Approved medicines Oncology Late-stage development AZD4635 (A2AR inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Phase Ia: patients with 48-90 • Phase Ia: dose escalation to determine the MTD of AZD4635 Primary outcome measure: • FPCD: Q2 2016 advan
Slide 47: AZD4785 (KRAS antisense oligonucleotide)
Approved medicines Oncology Late-stage development AZD4785 (KRAS antisense oligonucleotide) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Phase Ia: patients with 30 (estimated) • Phase Ia: dose escalation to determine the MTD of AZD4785 Primary outcome measu
Slide 48: AZD5069 (CXCR2 antagonist)
Approved medicines Oncology Late-stage development AZD5069 (CXCR2 antagonist) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase Ib/II Metastatic pancreatic ductal 16 Dose escalation and expansion arms: • Safety/efficacy trial • FPCD: Q1 2016 carcinoma • Data antic
Slide 49: AZD5153 (BRD4 inhibitor)
Approved medicines Oncology Late-stage development AZD5153 (BRD4 inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I/Ib Relapsed/refractory solid 54 Dose Escalation advanced solid and lymphomas • Primary: safety • FPCD: Q2 2017 tumours, lymphomas Six do
Slide 50: AZD5991 (MCL1 inhibitor)
Approved medicines Oncology Late-stage development AZD5991 (MCL1 inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/refractory 48 Dose escalation in relapsed/refractory haematological • Primary: safety • FPCD: Q3 2017 haematologic malignancies
Slide 51: AZD6738 (ATR inhibitor)
Approved medicines Oncology Late-stage development AZD6738 (ATR inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Solid tumours 160 • Arm 1: AZD6738 + carboplatin • Safety and tolerability • FPCD: Q4 2014 • Arm 2: AZD6738 dose escalation, AZD6738 + Ly
Slide 52: AZD8186 (PI3Kb/d inhibitor)
Approved medicines Oncology Late-stage development AZD8186 (PI3Kb/d inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced castrate resistant 153 • Part A: AZD8186 monotherapy in ascending intermittent doses • Part A: PK, MTD and recommended • FPC
Slide 53: AZD9150 (STAT3 inhibitor)
Approved medicines Oncology Late-stage development AZD9150 (STAT3 inhibitor) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase Ib/II Head and neck squamous-cell 405 Dose escalation advanced solid and blood cancers • Safety/efficacy trial • FPCD: Q3 2015 carcinoma
Slide 54: AZD9496 (selective estrogen receptor degrader)
Approved medicines Oncology Late-stage development AZD9496 (selective estrogen receptor degrader) Early development Breast cancer Trial Population Patients Design Endpoints Status CVRM Phase I ER+ Breast Cancer c. 50 • This is an open label randomised multicentre pre-surgical • Primary Outcome Measu
Slide 55: AZD9833 (selective estrogen receptor degrader)
Approved medicines Oncology Late-stage development AZD9833 (selective estrogen receptor degrader) Early development Breast cancer Trial Population Patients Design Endpoints Status CVRM Phase I ER+ breast cancer 240 • This is a Phase I open label multicentre trial of AZD9833 • Primary outcome measure
Slide 56: MEDI2228 (BCMA antibody drug conjugate)
Approved medicines Oncology Late-stage development MEDI2228 (BCMA antibody drug conjugate) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/Refractory Multiple 129 First-time-in-human Phase I, multi-centre, open-label, single-arm, Primary endpoints: •
Slide 57: MEDI3726 (PSMA antibody drug conjugate)
Approved medicines Oncology Late-stage development MEDI3726 (PSMA antibody drug conjugate) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I/Ib Subjects with metastatic 224 Open-label, Dose-escalation and Dose-expansion Primary endpoint: • FPCD: Q1 2017 castrati
Slide 58: MEDI4276 (HER2 ADC)
Approved medicines Oncology Late-stage development MEDI4276 (HER2 ADC) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced HER2+ metastatic 47 • First-time-in-human Phase I, multi-centre, open-label, single- • Primary endpoint: safety • FPCD: Q4 2015 brea
Slide 59: MEDI5083 (CD40 Ligand fusion protein) + Imfinzi
Approved medicines Oncology Late-stage development MEDI5083 (CD40 Ligand fusion protein ) Early development + Imfinzi (PD-L1 mAb) Cancer CVRM Trial Population Patients Design Endpoints Status Phase I Advanced solid tumours 204 Dose-escalation phase Primary endpoints: • FPCD: Q1 2017 • Part 1: MEDI50
Slide 60: MEDI5752 (PD-1/CTLA-4 bispecific mAb)
Approved medicines Oncology Late-stage development MEDI5752 (PD-1/CTLA-4 bispecific mAb) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Advanced solid tumour 263 Open-label, Dose-escalation and Dose-expansion Primary endpoints: • FPCD: Q2 2018 • Dose-escalati
Slide 61: MEDI7247 (PBD ADC mAb)
Approved medicines Oncology Late-stage development MEDI7247 (PBD ADC mAb) Early development Cancer Trial Population Patients Design Endpoints Status CVRM Phase I Relapsed/Refractory 408 First-time-in-human Phase I, multi-centre, open-label, single-arm, • Primary endpoint: safety • FPCD: Q2 2017 NCT0
Slide 62: CVRM, Respiratory and Other – approved medicines and late-stage pipeline
AstraZeneca CVRM, Respiratory and Other – approved medicines and late-stage pipeline
Slide 63: Farxiga: diabetes
Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development Diabetes Trial Population Patients Design Endpoints Status CVRM Phase III/IV Type-2 diabetes 17,190 • Arm 1: Farxiga 10mg QD + SoC therapy QD • Primary endpoints: Superiority for major • FPCD: Q2 2013 DECL
Slide 64: Farxiga: diabetes / cardiovascular risk reduction
Approved medicines Oncology Late-stage development Farxiga (SGLT2 inhibitor) Early development Diabetes / cardiovascular risk reduction Trial Population Patients Design Endpoints Status CVRM Phase III Chronic Heart Failure (CHF) 4,744 • Arm 1: Farxiga 10mg or 5 mg QD + standard of care therapy • Pri
Slide 65: Brilinta: cardiovascular risk reduction
Approved medicines Oncology Late-stage development Brilinta (ADP receptor antagonist) Early development Cardiovascular risk reduction Trial Population Patients Design Endpoints (primary) Status CVRM Phase III Patients with type-2 diabetes 19,000 • Arm 1: Brilinta 60mg BID • Primary endpoint: Composi
Slide 66: Epanova: hypertriglyceridaemia
Approved medicines Oncology Late-stage development Epanova (omega-3 carboxylic acids) Early development Hypertriglyceridaemia Trial Population Patients Design Endpoints Status CVRM Phase III Patients with 13,000 • Arm 1: Epanova 4g QD + statin • Primary endpoint: Composite of Major • FPCD: Q4 2014 S
Slide 67: Lokelma: hyperkalaemia
Approved medicines Oncology Late-stage development Lokelma (sodium zirconium cyclosilicate) Early development Hyperkalaemia Trial Population Patients Design Endpoints Status CVRM Phase III Hyperkalaemia 248 Open-label Lokelma 10g TID for 48 hours followed by: • Primary endpoint: Maintenance of • FPC
Slide 68: Roxadustat: anaemia
Approved medicines Oncology Roxadustat (China: ) (HIF-PHI inhibitor) Late-stage development Early development Anaemia Trial Population Patients Design Endpoints Status CVRM Phase III ANDES Anaemia in CKD (Chronic 922 • Arm 1: roxadustat • Primary endpoint: Haemoglobin • FPCD: Q4 2012 Kidney Disease)
Slide 69: Roxadustat: anaemia
Approved medicines Oncology Roxadustat (China: ) (HIF-PHI inhibitor) Late-stage development Early development Anaemia Trial Population Patients Design Endpoints Status CVRM Phase III HIMALAYAS Anaemia in newly initiated 900 • Arm 1: roxadustat • Primary endpoint: Haemoglobin • FPCD: Q4 2013 dialysis
Slide 70: Eklira/Tudorza: COPD
Approved medicines Oncology Late-stage development Eklira/Tudorza (LAMA, DPI) Early development Chronic obstructive pulmonary disease (COPD) Trial Population Number of patients Design Endpoints Status CVRM Phase I Healthy Chinese 18 Open-label, 2-period ascending dose incomplete block, cross-over •
Slide 71: Duaklir Genuair: COPD
Approved medicines Oncology Late-stage development Duaklir Genuair (LAMA/LABA, DPI) Early development Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase III Patients with stable COPD 1,060 • Arm 1: Duaklir Genuair 400/12 μg DPI Primary endpoints
Slide 72: Bevespi Aerosphere: COPD
Approved medicines Oncology Late-stage development Bevespi Aerosphere (LAMA/LABA, pMDI) Early development Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to very severe 2,103 Treatment (24-week Treatment Period) • Primary endpoin
Slide 73: Bevespi Aerosphere: COPD
Approved medicines Oncology Late-stage development Bevespi Aerosphere (LAMA/LABA, pMDI) Early development Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design (G = glycopyrronium, F = formoterol fumarate) Endpoints Status CVRM Phase III Moderate to very severe 1,614 Treatmen
Slide 74: Daliresp/Daxas: COPD
Approved medicines Oncology Late-stage development Daliresp/Daxas (PDE4 inhibitor, oral) Early development Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase IV COPD 2,354 • 52W, randomised, DB with Daliresp 500µg OD vs. placebo, in • Primary en
Slide 75: Fasenra: severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III A multi-centre, open-label, 770 • Arm 1: Fasenra 30mg Q4W SC • Primary endpoint: Safety and tolerability • FPCD: Q2 20
Slide 76: Fasenra: severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe asthma, inadequately 2,550 • Arm 1: Fasenra 30mg Q4W SC • Primary endpoint: Safety and tolerability • FPCD: Q4
Slide 77: Fasenra: severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe asthma 230 • Arm 1: Fasenra 30mg Q4W SC • Primary endpoint: Onset and • FPCD: Q4 2016 SOLANA Age 18-75 years •
Slide 78: Fasenra: nasal polyps
Approved medicines Oncology Late-stage development Fasenra (IL-5R mAb) Early development Nasal polyps Trial Population Patients Design Endpoints Status CVRM Phase III Patients with severe bilateral 400 • Arm 1: Fasenra 30mg Q8W SC • Primary endpoint: Effect of Fasenra on • FPCD: Q1 2018 OSTRO nasal
Slide 79: PT010: COPD
Approved medicines Oncology Late-stage development PT010 (LAMA/LABA/ICS, pMDI) Early development Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to very severe 500 Treatments (52-week Treatment Period) Primary endpoints: • FPCD:
Slide 80: PT027: asthma
Approved medicines Oncology Late-stage development PT027 (ICS/SABA, pMDI) Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to severe asthma 3,100 Treatments (minimum 24-week treatment period) Primary endpoint: • FPCD: Q4 2018 MANDALA • BDA (budesonid
Slide 81: Tezepelumab: severe, uncontrolled asthma
Approved medicines Oncology Late-stage development Tezepelumab (TSLP mAb) Early development Severe, uncontrolled asthma Trial Population Patients Design Endpoints Status CVRM Phase III Severe asthma 1,060 • Arm 1: tezepelumab SC • Primary endpoint: Annual asthma • FPCD: Q1 2018 NAVIGATOR Age 12-80 y
Slide 82: Anifrolumab: SLE / lupus nephritis
Approved medicines Oncology Late-stage development Anifrolumab (type I IFN receptor mAb) Early development Systemic lupus erythematosus (SLE) / Lupus nephritis (LN) Trial Population Patients Design Endpoints Status CVRM Phase III Moderate to severe SLE 450 • Arm 1: 300mg IV anifrolumab Q4W for 48 we
Slide 83: CVRM, Respiratory and Other – early-stage development
AstraZeneca CVRM, Respiratory and Other – early-stage development
Slide 84: Verinurad: chronic kidney disease
Approved medicines Oncology Late-stage development Verinurad (RDEA3170, URAT1 inhibitor) Early development Chronic kidney disease Trial Population Patients Design Endpoints Status CVRM Phase II CKD (Chronic Kidney 60 • Arm A: verinurad 9 mg and febuxostat 80 mg To assess the effects of intensive uri
Slide 85: AZD4831 (MPO inhibitor)
Approved medicines Oncology Late-stage development AZD4831 (MPO inhibitor) Early development Cardiovascular disease Trial Population Patients Design Endpoints Status CVRM AZD4831 (MPO) Healthy subjects c. 96 SAD trial (one trial site in Germany) • Safety and tolerability • FPCD: Q3 2016 • Planned to
Slide 86: AZD5718 (FLAP inhibitor)
Approved medicines Oncology Late-stage development AZD5718 (FLAP inhibitor) Early development Cardiovascular disease Trial Population Patients Design Endpoints Status CVRM AZD5718 (FLAP) Healthy subjects 96 SMAD trial (one trial site in UK) • Safety and tolerability • FPCD: Q1 2016 SAD • PK paramete
Slide 87: AZD8233 (anti-hypercholesterolemia)
Approved medicines Oncology Late-stage development AZD8233 (anti-hypercholesterolemia) Early development Hypercholesterolemia Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 40 SAD Primary: • FPCD: Q3 2018 • Safety and tolerability NCT03593785 Dose escalation in 5 coh
Slide 88: AZD8601 (VEGF-A modified RNA)
Approved medicines Oncology Late-stage development AZD8601 (VEGF-A modified RNA) Early development Cardiovascular disease Trial Population Patients Design Endpoints Status CVRM Phase I Type 2 diabetic patients c. 60 SAD trial (one trial site in Germany) • Safety and tolerability • FPCD: Q1 2017 • Pl
Slide 89: AZD9977: heart failure with preserved ejection fraction
Approved medicines Oncology Late-stage development AZD9977 Early development Heart failure with preserved ejection fraction Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 27 MAD Primary: • FPCD: Q1 2018 • Safety and tolerability • LPCD: Q2 2018 NCT03435276 Dose escal
Slide 90: Cotadutide (MEDI0382): diabetes/obesity
Approved medicines Oncology Late-stage development Cotadutide (MEDI0382, GLP-1-glucagon agonist) Early development Diabetes/obesity Trial Population Patients Design Endpoints Status CVRM Phase I Healthy adult subjects 64 • SAD SC administration • Primary: Safety profile in terms of adverse events (A
Slide 91: Cotadutide (MEDI0382): diabetes/obesity
Approved medicines Oncology Late-stage development Cotadutide (MEDI0382, GLP-1-glucagon agonist) Early development Diabetes/obesity Trial Population Patients Design Endpoints Status CVRM Phase I Healthy adult subjects 22 • Open label, one sequence, cross-over • Effect of MEDI0382 on PK & PD of warfa
Slide 92: Cotadutide (MEDI0382): diabetes/obesity
Approved medicines Oncology Late-stage development Cotadutide (MEDI0382, GLP-1-glucagon agonist) Early development Diabetes/obesity Trial Population Patients Design Endpoints Status CVRM Phase II Overweight and 24 • MEDI0382 or placebo SC • Primary: Efficacy body weight loss • FPCD: Q4 2018 NCT03596
Slide 93: MEDI7219 (anti-diabetic)
Approved medicines Oncology Late-stage development MEDI7219 (anti-diabetic) Early development Diabetes Trial Population Patients Design Endpoints Status CVRM Phase I Healthy Volunteers 104 • 4 part trial • Safety and tolerability • FPCD: Q1 2018 • Part A : SAD • Pharmacokinetics • Data anticipated:
Slide 94: Biologics: cardiovascular & metabolic diseases
Approved medicines Oncology Late-stage development Biologics Early development Cardiovascular & metabolic diseases Trial Compound Population Patients Design Endpoints Status CVRM Phase IIb MEDI6012 Subjects 30-80 414 • Cohort A: 2-Dose Regimen Primary endpoints: Infarct size as a percentage of left
Slide 95: AZD1402 (IL4 receptor antagonist)
Approved medicines Oncology Late-stage development AZD1402 (IL4 receptor antagonist) Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects Inhaled: 56 SAD. Primary endpoint: • FPCD: Q4 2017 A dose escalating single blind trial to assess the safety,
Slide 96: AZD1419 (TLR9 agonist)
Approved medicines Oncology Late-stage development AZD1419 (TLR9 agonist) Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase IIa Adults with eosinophilic, 81 • Arm 1: AZD1419, once-weekly adaptive dosing (4mg, 1mg, • Time to loss of asthma control • FPCD: Q4 2016 I
Slide 97: AZD8154 (PI3Kgδ inhibitor)
Approved medicines Oncology Late-stage development AZD8154 (PI3Kgδ inhibitor) Early development Asthma Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 54 SAD Primary endpoint: • FPCD: Q3 2018 A Phase 1 trial to assess the safety, tolerability and • Safety and tolerabi
Slide 98: AZD8871 (MABA, inhaled)
Approved medicines Oncology Late-stage development AZD8871 (MABA, inhaled) Early development Respiratory Trial Population Patients Design Endpoints Status CVRM Phase IIa Patients with chronic 72 Randomised, double-blind, placebo and active-controlled Primary endpoint: • FPCD: Q4 2018 obstructive pul
Slide 99: AZD9567 (SGRM, oral)
Approved medicines Oncology Late-stage development AZD9567 (SGRM, oral) Early development Respiratory Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 71 MAD trial with a total of 6 dose levels of AZD9567: 10 mg, 20mg, Primary endpoint: • FPCD: Q2 2016 40mg, 80mg and 1
Slide 100: MEDI3506 (IL-33 mAb) ligand
Approved medicines Oncology Late-stage development MEDI3506 (IL-33 mAb) ligand Early development Chronic obstructive pulmonary disease (COPD) Trial Population Patients Design Endpoints Status CVRM Phase I (Combined SDE / SDE: Healthy subjects with SDE: 56 SDE: • Safety and tolerability • FPCD: Q2 20
Slide 101: AZD0284 (RORγ inverse agonist)
Approved medicines Oncology Late-stage development AZD0284 (RORγ inverse agonist) Early development Plaque psoriasis vulgaris Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects 80 Part 1 (SAD) • Safety and tolerability and PK following • FPCD: Q3 2016 • Seven different d
Slide 102: AZD5634 (epithelial NaC inhibitor)
Approved medicines Oncology Late-stage development AZD5634 (epithelial NaC inhibitor) Early development Cystic fibrosis Trial Population Patients Design Endpoints Status CVRM Phase I Healthy subjects Part A: 57 SAD Primary endpoint: • FPCD: Q1 2016 Part B: 6 A Phase I, randomised, single-blind, plac
Slide 103: Other biologics: infections
Approved medicines Oncology Late-stage development Other biologics Early development Infections Trial Compound Population Patients Design Endpoints Status CVRM Phase II Anti-Staph AT Intubated Intensive 213 • Placebo-controlled, single-dose, dose-ranging • Efficacy and safety • FPCD: Q4 2014 (suvrat
Slide 104: MEDI0700 - AMG (Anti-B7RP-1 mAb/BAFF)
Approved medicines Oncology Late-stage development MEDI0700 - AMG 570 (Anti-B7RP-1 mAb/BAFF) Early development Systemic lupus erythematosus (SLE) Trial Population Patients Design Endpoints Status CVRM Phase Ia Healthy volunteers 56 Single Ascending Dose • Safety and tolerability • FPCD: Q1 2016 • Ar
Slide 105: MEDI1341 (alpha-synuclein mAb)
Approved medicines Oncology Late-stage development MEDI1341 (alpha-synuclein mAb) Early development Parkinson’s Disease Trial Population Patients Design Endpoints Status CVRM Phase I Healthy volunteers 40 • SAD • Safety, tolerability, PK, PD • FPCD: Q4 2017 • Up to 5 IV cohorts are planned vs placeb
Slide 106: MEDI1814 (amyloid beta mAb)
Approved medicines Oncology Late-stage development MEDI1814 (amyloid beta mAb) Early development Alzheimer’s disease Trial Population Patients Design Endpoints Status CVRM Phase I Alzheimer’s disease & healthy 121 • SAD & MAD • Safety, tolerability • FPCD: Q2 2014 elderly • Up to 10 IV cohorts are p
Slide 107: Prezalumab (MEDI5872, B7RP-1 mAb)
Approved medicines Oncology Late-stage development Prezalumab (MEDI5872, B7RP-1 mAb) Early development Systemic lupus erythematosus (SLE) Trial Population Patients Design Endpoints Status CVRM Phase IIa Primary Sjögren's syndrome 32 • Arm 1: MEDI5872 210mg SC QW for 3 weeks and then Q2W • Safety and
Slide 108: MEDI7352 (NGF TNF bispecific mAb)
Approved medicines Oncology Late-stage development MEDI7352 (NGF TNF bispecific mAb) Early development Osteoarthritis pain Trial Population Patients Design Endpoints Status CVRM Phase I Painful osteoarthritis of the knee 160 • SAD & MAD • Safety, tolerability, PK, PD • FPCD: Q1 2016 • Up to 10 IV co
Slide 109: Clinical trials appendix Q4 2018 results update
Clinical trials appendix Q4 2018 results update