Clinical trials appendix Q1 2019 results update - AstraZeneca
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Clinical trials appendix Q1 2019 results update
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 March 2019, unless otherwise specified.
It includes estimated timelines with regards to trial completion and first external
presentations of primary data. These estimates are subject to change, as
programmes recruit faster or slower than anticipated and many times are event
driven.
Project postings on clinicaltrials.gov are updated on a continuous basis as projects
progress. For the most up to date information on our clinical programmes please
visit clinicaltrials.gov
2
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
BD/BID Bis in die (two times a day) LABA Long acting beta agonist Q3W Quaque (every) three weeks
CE Clinically evaluable LAMA Long acting muscarinic agonist Q4W Quaque (every) four weeks
CMAX Maximum concentration absorbed LCM Lifecycle management Q8W Quaque (every) eight weeks
CNS Central nervous system LPCD Last patient commenced dosing QD Quaque die (one time a day)
DCR Disease control rate MAD Multiple ascending dose QOD Quaque altera die (every other day)
DDI Drug-drug interaction MDI Metered-dose inhaler QoL Quality of life
DFS Disease free survival MTD Maximum tolerated dose SAD Single ascending dose
DLT Dose-limiting toxicity NME New molecular entity SC Subcutaneous
DoR Duration of response OCS Oral corticosteroid SoC Standard of care
DPI Dry powder inhaler ORR Objective response rate TID Ter In die (three times a day)
FDC Fixed-dose combination OS Overall survival VEGF Vascular endothelial growth factor
FEV Forced-expiratory volume PARP Poly ADP ribose polymerase XR Extended release
FPCD First patient commenced dosing PD Pharmacodynamics
HRRm Homologous recombination repair mutation PFS Progression-free survival
PK Pharmacokinetics
3
Table of contents slide
Movement since Q4 2018 update
Q1 2019 NME pipeline
Q1 2019 LCM pipeline
Oncology
Approved medicines and late-stage development
Early-stage development
Cardiovascular, Renal & Metabolism (CVRM), Respiratory & Other medicines
Approved medicines and late-stage development
Early-stage development
4Movement since Q4 2018 update
New to Phase I New to Phase II New to Pivotal Study New to Registration
Additional indication NME NME Lifecycle Management
MEDI7247 trastuzumab deruxtecan¶# DESTINY-Breast01 Lynparza# + Imfinzi# + bevacizumab DUO-O Farxiga3 DECLARE-TIMI 58 [US & EU]1
ASCT2 antibody drug conjugate solid ADC HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated PARP inhibitor + PD-L1 mAb + VEGF inhibitor SGLT2 inhibitor CV outcomes trial in patients
tumours with trastuzumab emtansine 1st-line ovarian cancer with type-2 diabetes
Additional indication
Additional indication
capivasertib#
trastuzumab deruxtecan# DESTINY-Breast02
AKT inhibitor prostate cancer ADC HER2-positive, unresectable and/or metastatic
Imfinzi# + Lynparza# ORION breast cancer pretreated with prior standard of care
PD-L1 mAb + PARP inhibitor NSCLC HER2 therapies, including trastuzumab emtansine
(oleclumab + chemotherapy) or (Imfinzi# + oleclumab + chemotherapy) trastuzumab deruxtecan# DESTINY-Breast03
(CD73 mAb+chemo) or (PD-L1 mAb+CD73 mAb+chemo) metastatic pancreatic cancer ADC HER2-positive, unresectable and/or metastatic
breast cancer subjects previously treated with
trastuzumab deruxtecan¶# DESTINY-Gastric01 trastuzumab and taxane
ADC HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma
patients who have progressed on two prior treatment regimens trastuzumab deruxtecan# DESTINY-Breast04
ADC HER2-low, unresectable and/or metastatic breast
trastuzumab deruxtecan# cancer subjects
ADC HER2-expressing advanced colorectal cancer
trastuzumab deruxtecan#
HER2-over-expressing or -mutated, unresectable and/or metastatic NSCLC Lifecycle Management
Calquence# + venetoclax + obinutuzumab
Lifecycle Management BTK inhibitor + BCL-2 inhibitor + anti-CD20 mAb 1st-line
Imfinzi# (platform) BEGONIA chronic lymphocytic leukaemia
PD-L1 mAb breast cancer
Imfinzi# CALLA
Imfinzi# (platform) MEGELLAN PD-L1 mAb adjuvant locally-advanced cervical cancer
PD-L1 mAb NSCLC
Imfinzi# + (oleclumab or monalizumab#) COAST
PD-L1 mAb + (CD73 mAb or NKG2A mAb) NSCLC
Imfinzi# + (oleclumab or monalizumab# or danvatirsen#) NeoCOAST
PD-L1 mAb + (CD73 mAb or NKG2A mAb or STAT3 inhibitor) NSCLC
Lynparza# (basket) MK-7339-002 / LYNK002
PARP inhibitor HRRm cancer
Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration
NME NME Lifecycle Management
Imfinzi# + dabrafenib + trametinib AZD4547 Farxiga3 DEPICT [US & JP]2
PD-L1 mAb + BRAF inhibitor + MEK FGFR inhibitor solid tumours SGLT2 inhibitor type-1 diabetes
inhibitor melanoma
AZD8186
Imfinzi# + Iressa PI3k inhibitor solid tumours
PD-L1 mAb + EGFR inhibitor NSCLC
Imfinzi# + MEDI0680
AZD0156 PD-L1 mAb + PD-1 mAb solid tumours
ATM inhibitor solid tumours
prezalumab#
AZD4785 B7RP1 mAb primary Sjöogren’s syndrome
KRAS inhibitor solid tumours
5
¶ Registrational Phase II/III trial # Partnered and/or in collaboration 1 Submission Accepted 2 Submission Approved 3Farxiga in the US; Forxiga in ROWQ1 2019 New Molecular Entity (NME)1 pipeline
Phase I Phase II Phase III Under Review
21 New Molecular Entities 25 New Molecular Entities 14 New Molecular Entities 0 New Molecular Entities
AZD1390 Imfinzi#+tremelimumab+chemo adavosertib#+chemotherapy Imfinzi#+tremelimumab trastuzumab deruxtecan# DESTINY-Breast02
glioblastoma PD-L1+CTLA-4 1L PDAC oesophageal SCLC Wee1+chemo ovarian cancer PD-L1+CTLA-4 gastric cancer ADC breast
AZD4573 Imfinzi+selumetinib# AZD2811# Imfinzi#+tremelimumab trastuzumab deruxtecan# DESTINY-Breast03
CDK9 haematalogical malignancies PL-L1+MEK solid tumours Aurora solid tumours PD-L1+CTLA-4 biliary tract oesophageal ADC breast
AZD5153 MEDI2228 AZD4635 Imfinzi+Lynparza# BAYOU trastuzumab deruxtecan# DESTINY-Breast04
BRD4 solid tumours BCMA ADC multiple myeloma A2aR inhibitor solid tumours PD-L1+PARP bladder ADC breast
AZD5991 MEDI3726# AZD6738 Lynparza#+adavosertib# Imfinzi#+tremelimumab DANUBE
MCL1 haematalogical malignancies PSMA ADC prostate ATR solid tumours PARP+Wee1 solid tumours PD-L1+CTLA-4 1L bladder
AZD9496 MEDI5083 capivasertib# Lynparza#+AZD6738 Imfinzi#+tremelimumab HIMALAYA
SERD ER+ breast CD40 ligand fusion protein solid tumours AKT breast prostate PARP+ATR gastric PD-L1+CTLA-4 1L HCC
Imfinzi#+(oleclumab or monalizumab# or
AZD9833 MEDI5752 Lynparza#+AZD6738 or +adavosertib# VIOLETTE Imfinzi#+tremelimumab KESTREL
danvatirsen#) NeoCOAST
SERD ER+ breast PD-1/CTLA-4 solid tumours PARP+ATR or PARP+Wee1 breast PD-L1+CTLA-4 1L HNSCC
PD-L1+(CD73 or NKG2A or STAT3) NSCLC
MEDI7247
Calquence+AZD6738 Imfinzi#+(oleclumab or monalizumab#) COAST Lynparza#+Imfinzi MEDIOLA Imfinzi#+tremelimumab NEPTUNE
ASCT2 ADC haematological malignancies solid
BTK+ATR haematalogical tumours PD-L1+(CD73 or NKG2A) NSCLC PARP+PD-L1 ovarian breast gastric SCLC PD-L1+CTLA-4 1L NSCLC
tumours
Imfinzi#+AZD5069 or Imfinzi#+danvatirsen#
Calquence+danvatirsen oleclumab oleclumab+chemo or Imfinzi#+oleclumab+chemo Imfinzi#+tremelimumab+CRT ADRIATIC
PD-L1+(CXCR2 or STAT3) HNSCC bladder
BTK+STAT3 haematalogical malignancies CD73 solid tumours CD73+chemo or PD-L1+CD73+chemo pancreatic PD-L1+CTLA-4+CRT LD-SCLC
NSCLC
Imfinzi#+adavosertib# oleclumab+AZD4635 Imfinzi#+Lynparza# ORION Tagrisso combo# TATTON Imfinzi#+tremelimumab+SoC CASPIAN
PD-L1+Wee1 solid tumours CD73+A2aR EGFRm NSCLC PD-L1+PARP NSCLC EGFR+PD-L1/MEK/MET NSCLC PD-L1+CTLA-4+SoC 1L SCLC
Imfinzi#+RT (platform) CLOVER oleclumab+Tagrisso Imfinzi#+MEDI0457# trastuzumab deruxtecan#¶ DESTINY-Breast01 Imfinzi#+tremelimumab+SoC NILE
PD-L1+RT HNSCC NSCLC SCLC CD73+EGFR EGFRm NSCLC PD-L1+DNA HPV vaccine HNSCC ADC breast PD-L1+CTLA-4+SoC 1L urothelial cancer
Imfinzi#+tremelimumab Imfinzi#+monalizumab# trastuzumab deruxtecan#¶ DESTINY-Gastric01 Imfinzi#+tremelimumab+SoC POSEIDON
PD-L1+CTLA-4 solid tumours PD-L1+NKG2a solid tumours ADC gastric PD-L1+CTLA-4+SoC 1L NSCLC
Imfinzi#+oleclumab trastuzumab deruxtecan# Lynparza#+Imfinzi#+bevacizumab DUO-O
PD-L1+CD73 solid tumours ADC colorectal cancer PARP+PD-L1+VEGF 1L ovarian
trastuzumab deruxtecan# savolitinib# SAVOIR
ADC NSCLC MET pRCC
selumetinib#¶ SPRINT
MEK paediatric neurofibromatosis type-1
6 1
includes novel combinations and additional indications for assets where the lead is not yet launched
Oncology Cardiovascular, Renal & Metabolism, Respiratory, Other
# Partnered and/or in collaboration; ¶ Registrational Phase II/III trialQ1 2019 New Molecular Entity (NME)1 pipeline
Phase I Phase II Phase III Applications Under Review
13 New Molecular Entities 22 New Molecular Entities 3 New Molecular Entities 1 New Molecular Entity
AZD0284 abediterol# MEDI5884# anifrolumab# TULIP PT010
RORg psoriasis/respiratory LABA asthma/COPD cholesterol modulation cardiovascular Type I IFN receptor SLE LABA/LAMA/ICS COPD
AZD0449 anifrolumab# MEDI6012 PT027
Inhaled JAK inhibitor asthma Type I IFN receptor SLE SC LCAT cardiovascular ICS/SABA asthma
AZD1402# anifrolumab# MEDI7352 tezepelumab# NAVIGATOR SOURCE
inhaled IL-4Ra asthma Type I IFN receptor lupus nephritis NGF/TNF osteoarthritis pain, painful TSLP severe uncontrolled asthma
diabetic neuropathy
AZD5634 AZD1419# MEDI8852
inhaled ENaC cystic fibrosis inhaled TLR9 asthma influenza A treatment
AZD8154 AZD4831 MEDI8897#
Inhaled PI3Kgd asthma MPO HFpEF passive RSV prophylaxis
AZD8233 AZD5718 PT010
hypercholesterolemia cardiovascular FLAP coronary artery disease LABA/LAMA/ICS asthma
AZD9977 AZD7594 suvratoxumab
MCR cardiovascular Inhaled SGRM asthma/COPD α-Toxin Staphylococcus pneumonia
MEDI0700# AZD7986# tezepelumab#
BAFF/B7RP1 SLE DPP1 COPD TSLP atopic dermatitis
MEDI1341 AZD8601# verinurad
alpha synuclein parkinson's disease VEGF-A cardiovascular URAT-1 chronic kidney disease
MEDI1814# AZD8871#
amyloidβ alzheimer's disease MABA COPD
MEDI3506 AZD9567
IL-33 COPD SGRM RA/respiratory
MEDI6570 cotadutide
LOX-1 CV disease GLP-1/glucagon type-2 diabetes / obesity
1
includes novel combinations and additional indications for assets where the lead is not yet launched
MEDI7219 MEDI3902
anti-diabetic type-2 diabetes Psl/PcrV Pseudomonas pneumonia # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial
7 Oncology Cardiovascular, Renal & Metabolism, Respiratory, OtherQ1 2019 Lifecycle Management (LCM)1 pipeline
Phase I Phase II Phase III Applications Under Review
1 Project 5 Projects 20 Projects 0 Projects
Imfinzi#+CTx neoadjuvant AEGEAN
Imfinzi#+azacitidine# Imfinzi# Calquence#
PD-L1+CTx locally-advanced stage III
PD-L1+azacitidine MDS PD-L1 solid tumours BTK inhibitor 1st line MCL
NSCLC
Imfinzi# (platform) BEGONIA Calquence# Imfinzi#+CTx NIAGARA
PD-L1 breast cancer BTK inhibitor 1st line CLL PD-L1+CTx muscle invasive bladder
cancer
Imfinzi# (platform) MAGELLAN Calquence# Imfinzi#+VEGF+TACE EMERALD-1
PD-L1 NSCLC BTK inhibitor r/r CLL, high risk PD-L1+VEGF+TACE locoregional HCC
Lynparza# (basket) MK-7339-002 /
Calquence# Lynparza# OlympiA
LYNK002
BTK inhibitor r/r CLL PARP gBRCA adjuvant breast
PARP HRRm cancer
Lynparza#+cediranib CONCERTO Calquence#+venetoclax+obinutuzumab Lynparza# POLO
PARP+VEGF recurrent Pt-R ovarian BTK+BCL-2+anti-CD20 1st line CLL PARP pancreatic cancer
Imfinzi# CALLA
Lynparza# PROfound
PD-L1 adj. locally advanced cervical
cancer PARP prostate cancer
Imfinzi# PEARL (China) Lynparza# SOLO-3
PD-L1 1L NSCLC PARP BRCAm PSR ovarian
Imfinzi# POTOMAC
PD-L1 non muscle invasive bladder Lynparza+abiraterone# PROpel
cancer PARP+NHA prostate cancer
Imfinzi#+CRT PACIFIC-2 Tagrisso ADAURA
PD-L1+CRT NSCLC EGFR adj. EGFRm NSCLC
Imfinzi#+CRT PACIFIC-5 (China) Tagrisso LAURA
PD-L1+CRT locally-advanced stage III EGFRm locally advanced unresectable
NSCLC NSCLC
1
Includes significant LCM projects and parallel indications for assets beyond Phase III
8 # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial Oncology Cardiovascular, Renal & Metabolism, Respiratory, OtherQ1 2019 Lifecycle Management (LCM)1 pipeline
Phase I Phase II Phase III Applications Under Review
0 Projects 0 Projects 10 Projects 4 Projects
Brilinta/Brilique HESTIA Farxiga/Forxiga DECLARE
P2Y12 paeds w/ sickle cell outcomes
Brilinta/Brilique THALES Nexium (CN only)
P2Y12 stroke stress ulcer prophylaxis
Brilinta/Brilique THEMIS saxagliptin+dapagliflozin metformin
P2Y12 diabetes & CAD outcomes DPP4+SGLT2 type-2 diabetes
Epanova STRENGTH Symbicort SYGMA
outcomes as needed in mild asthma
Farxiga/Forxiga
SGLT2 HFrEF
Farxiga/Forxiga
SGLT2 CKD
Farxiga/Forxiga DELIVER
SGLT2 HFpEF
Fasenra#
IL-5R COPD
Fasenra# OSTRO
IL-5R nasal polyposis
roxadustat#
HIFPH anaemia MDS
1
Includes significant LCM projects and parallel indications for assets beyond Phase III
9 # Partnered and/or in collaboration; ¶ Registrational Phase II/III trial Oncology Cardiovascular, Renal & Metabolism, Respiratory, OtherEstimated key regulatory submission acceptances
roxadustat anaemia in CKD (US)
selumetinib SPRINT
Imfinzi + tremelimumab KESTREL
Imfinzi + tremelimumab NEPTUNE trastuzumab deruxtecan
Imfinzi + tremelimumab DANUBE Imfinzi + tremelimumab + CRT ADRIATIC
NME
Imfinzi +/- tremelimumab CASPIAN Imfinzi + tremelimumab HIMALAYA PT027 asthma
Imfinzi +/- tremelimumab POSEIDON Lokelma (China) Imfinzi + tremelimumab + SoC NILE Fasenra severe asthma (China)
trastuzumab deruxtecan DESTINY-Breast01 (US) Lumoxiti (EU) Lynparza +Imfinzi +bevacizumab DUO-O tezepelumab NAVIGATOR
H2 2019 2020 2020+
Calquence CLL Imfinzi PEARL Calquence 1L MCL Brilinta HESTIA
LCM
Lynparza POLO Lynparza PAOLA-1 Calquence +venetoclax+obinutuzumab 1L CLL Farxiga DAPA-CKD
Lynparza SOLO-3 Lynparza PROFOUND Imfinzi POTOMAC Farxiga HFpEF DELIVER
Brilinta THEMIS Farxiga DAPA-HF Imfinzi CALLA roxadustat anemia in MDS
Lokelma (JP) Brilinta THALES Imfinzi BR.31 ADJUVANT Duaklir Genuair (China)
Symbicort SYGMA (China) Epanova STRENGTH Imfinzi + CRT PACIFIC-2
Fasenra OSTRO Imfinzi + CRT PACIFIC-5 (China)
Xigduo (China) Imfinzi + chemo AEGEAN
Imfinzi + chemo NIAGARA
Imfinzi + VEGF + TACE EMERALD-1
Lynparza OLYMPIA
Lynparza + abiraterone PROPEL
Tagrisso LAURA
Tagrisso ADAURA
10 Oncology Cardiovascular, Renal & Metabolism, Respiratory, OtherDesignations
4
Accelerated approvals
9
Breakthrough Therapy
8
Fast Track
20
Priority Review / PRIME
23
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 T790M NSCLC (US) Lynparza prostate cancer PROFOUND (US) savratoxumab Staph HAP (US) Tagrisso EGFRm T790M NSCLC (US) Lumoxiti HCL PLAIT (US)
Imfinzi bladder cancer (US) Imfinzi bladder cancer 1L (US) Imfinzi NSCLC (US) Imfinzi bladder cancer 2L (US) Lumoxiti HCL PLAIT (EU)
Calquence MCL (US) Calquence MCL (US) MEDI8897 RSV mAB (US) Tagrisso NSCLC AURA3 (US) Crestor paediatric (US)
Imfinzi stage III NSCLC 1L PACIFIC (US) Imfinzi HNSCC HAWK (US) Calquence MCL (US) cediranib VEGFR tki (US)
Tagrisso NSCLC 1L FLAURA (US) anifrolumab SLE (US) Lynparza breast cancer OLYMPIAD (US) Iressa EGFRm NSCLC (US)
tezepelumab asthma (US) Lynparza ovarian cancer SOLO-2 (US) roxadustat CKD (CN) Tagrisso EGFRm T790M NSCLC (US)
MEDI8897 RSV mAB (US) Tagrisso EGFRm T790M NSCLC (CN) Tagrisso NSCLC FLAURA (US) AZD3241 MPO (EU)
selumetinib NFI type 1 SPRINT (US) Imfinzi stage III NSCLC PACIFIC (EU) Calquence CLL 1L (US)
Imfinzi stage III NSCLC PACIFIC (JP) Calquence MCL (US)
Lynparza tablet (US) Calquence WM (US)
Lynparza tablet (CN) Calquence WM (EU)
Lynparza breast cancer OLYMPIAD (JP) Calquence CLL 1L (EU)
Tagrisso NSCLC 1L FLAURA (JP) Calquence MCL (EU)
Lumoxiti HCL PLAIT (US) selumetinib thyroid cancer ASTRA (US)
Lynparza ovarian SOLO-1 (US) Lynparza breast cancer OLYMPIAD (JP)
Lynparza ovarian SOLO-1 (CN) Lynparza ovarian cancer SOLO-2 (JP)
PT010 Triple MDI COPD (CN) selumetinib NFI type 1 SPRINT (US)
MEDI8897 RSV mAB (EU) selumetinib NFI type 1 SPRINT (EU)
Tagrisso NSCLC 1L FLAURA (CN) Lynparza pancreatic cancer POLO (US)
Fasenra EGPA (US)
Fasenra HES (US)
Fast Track is a process designed to facilitate the development, and expedite the review of medicines to treat serious conditions and fill an unmet medical need.
Breakthrough Designation is a process designed to expedite the development and review of medicines which may demonstrate substantial improvement over available therapy. saracatinib IPF (US)
Accelerated Approval, these regulations allowed medicines for serious conditions that addressed an unmet medical need to be approved based on a surrogate endpoint.
Priority Review Designation is the US FDA’s goal to take action on an application within 6 months. PRIME is a scheme launched by the EMA to enhance support for the development of medicines that target an unmet medical need
Orphan Drug Designation, intended for treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 patients in the US, or that affect more than 200,000 patients but are not expected to recover the costs of developing and marketing a treatment drug.
11 Oncology Cardiovascular, Renal & Metabolism, Respiratory, OtherAstraZeneca Oncology – approved medicines and late-stage pipeline
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 endpoint: Disease Free Survival • FPCD: Q4 2015
ADAURA resection, with or without chemotherapy (DFS) • LPCD: Q1 2019
• Arm 2: placebo • Secondary endpoints: DFS Rate, OS, • Data anticipated: 2020+
NCT02511106 OS Rate, QoL
Global trial - 25 countries
Phase III Maintenance therapy in 200 • Arm 1: Tagrisso 80mg • Primary endpoint: PFS (via blinded • FPCD: Q3 2018
LAURA patients with • Arm 2: placebo independent central review (BICR)) • Data anticipated: 2020+
• Secondary endpoints: CNS PFS, OS,
locally advanced,
Respiratory
NCT03521154 unresectable EGFRm+ Stage Global trial - 11 countries DoR, ORR, DCR
III whose disease has not
progressed following
platinum-based
chemoradiation therapy
Phase II EGFRm+ / MET+, locally 172 • Single arm trial: Tagrisso + savolitinib • Primary endpoint: ORR • FPCD Q1 2019
SAVANNAH advanced or metastatic • Secondary endpoints include PFS, DoR • Data anticipated: 2020+
NSCLC who have progressed Global trial and OS
NCT03778229 following treatment with
Tagrisso
Other
Phase Ib Advanced EGFRm TKI failure 308 • Arm 1: Tagrisso + Imfinzi • Safety, tolerability, pharmacokinetics • FPCD: Q3 2014
TATTON • Arm 2: Tagrisso + savolitinib and Preliminary anti-tumour activity • Data anticipated: 2020
• Arm 3: Tagrisso + selumetinib
NCT02143466 Enrolment to Imfinzi combination arms will not restart
Global trial
Phase III Real world setting in adult 3,020 Single-arm trial - Tagrisso 80mg • Primary endpoints: OS and safety • FPCD: Q3 2015
ASTRIS patients with advanced or • Secondary endpoint: PFS • LPCD: Q4 2017
metastatic, EGFR T790M+ Global trial - 16 countries
NCT02474355
Phase II EGFR TKI treatment-naïve 150 Single arm trial – Tagrisso 80 mg • Primary Endpoint: proportion of patients • FPCD: Q2 2018
ELIOS patients with locally-advanced with a given tumour genetic and
or metastatic EGFRm+ Global trial - five countries proteomic marker at the point of disease
NCT03239340 progression as defined by the
investigator
• Secondary endpoint: PFS, ORR, DoR
13Approved 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
ADJUVANT BR.31 IB (≥4cm) – stage IIIA • Arm 2: placebo • DFS • Data anticipated: 2020+
resected NSCLC
NCT02273375 (incl. EGFR/ALK positive) Global trial Secondary endpoint:
• OS
Partnered
Phase II/III Lung Master Stage IV squamous NSCLC 140 Umbrella trial with five arms based on biomarker expression: Primary endpoints: • FPCD: Q2 2014
Protocol patients • Substudy A: Imfinzi (non-match for other biomarker driven • ORR • Data anticipated: 2020+
• PFS
Respiratory
substudies) IVQ2W single arm Imfinzi Phase II only
NCT02154490 Biomarker-targeted • Substudy B: PI3K inhibitor vs. docetaxel • OS
2L therapy • Substudy C: CDK4/6 inhibitor vs, docetaxel
Partnered • Substudy D: AZD4547 (FGFR inhibitor) vs. docetaxel
• Substudy E: C-MET/HGFR Inhibitor + erlotinib vs. erlotinib
Phase III Unresected, locally-advanced 300 • Arm 1: Imfinzi IV Q4W + chemo/RT (radiation therapy) Primary endpoint: • FPCD: Q2 2018
NSCLC • Arm 2: placebo + chemo/RT • PFS • Data anticipated: 2020+
PACIFIC-2 • ORR
ex US global trial Secondary endpoint:
NCT03519971 • OS
Phase III Imfinzi following SBRT in 630 •Arm 1: Imfinzi IV Q4W following definitive SBRT (radiation Primary endpoint: •FPCD: Q1 2019
Other
unresected, Stage I/II NSCLC therapy) •PFS •Data anticipated: 2020+
PACIFIC-4 •Arm 2: placebo following definitive SBRT Secondary endpoint:
•OS
NCT03833154
Phase III Unresected, locally-advanced 360 Arm 1: Imfinzi IV Q4W following chemo/RT (radiation therapy) Primary endpoint: • FPCD: Q1 2019
NSCLC Arm 2: placebo following chemo/RT • PFS • Data anticipated: 2020+
PACIFIC-5 Secondary endpoint:
ex US global trial, China focus • OS
NCT03706690
Phase III Neoadjuvant NSCLC patients 300 Arm 1: Imfinzi + platinum-based chemotherapy Primary endpoint: • FPCD: Q1 2019
Stage II and III resected Arm 2: placebo + platinum-based chemotherapy • Major Pathological Response (mPR) • Data anticipated: 2020
AEGEAN NSCLC Secondary endpoint
(incl. EGFR/ALK positive) • Pathological complete response
NCT03800134 (pCR)
14Approved 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: Q4 2018
ADRIATIC lung cancer (SCLC) 1L • Arm 2: Imfinzi • PFS • Data anticipated: 2020+
following platinum-based • Arm 3: placebo • OS
NCT03703297 concurrent chemoradiation
therapy
Phase III NSCLC 1L 650 • Arm 1: Imfinzi Q4W Primary endpoint: • FPCD: Q1 2017
PEARL • Arm 2: chemotherapy • OS • LPCD: Q1 2019
• Data anticipated: 2020
Respiratory
NCT03003962 Asia trial
Phase III NSCLC 1L 960 • Arm 1: Imfinzi + tremelimumab • Primary endpoint: OS • FPCD: Q4 2015
NEPTUNE • Arm 2: SoC • Secondary endpoint: PFS • LPCD: Q2 2017
• Data anticipated: H2 2019
NCT02542293
Phase III NSCLC 1L 1,000 • Arm 1: Imfinzi + CTx Primary endpoint: • FPCD: Q2 2017
POSEIDON • Arm 2: Imfinzi + tremelimumab + chemotherapy • OS • LPCD: Q3 2018
• Arm 3: SoC • Data anticipated: H2 2019
NCT03164616
Phase III SCLC 1L 795 • Arm 1: Imfinzi + tremelimumab + EP (carboplatin or cisplatin + Primary endpoint: • FPCD: Q1 2017
Other
CASPIAN etoposide) • OS • LPCD: Q2 2018
• Arm 2: Imfinzi + EP (carboplatin or cisplatin + etoposide) • Data anticipated: H2 2019
NCT03043872 • Arm 3: EP (carboplatin or cisplatin + etoposide)
Phase II SCLC 80 • Arm A: Imfinzi + tremelimumab Q4W • Primary endpoint: ORR • FPCD: Q4 2016
BALTIC • Arm B: adavosertib and carboplatin BID • Data anticipated: 2020+
• Arm C: AZD6738 and Lynparza
NCT02937818
Phase II NSCLC 1L 200 • Arm A1: Imfinzi Primary endpoint: • FPCD: Q1 2019
MAGELLAN • Arm A2: Imfinzi + danvatirsen • Safety & tolerability • Data anticipated: 2020+
• Arm A3: Imfinzi + oleclumab Secondary endpoint:
NCT03819465 • Arm B1: Imfinzi + Investigator's choice of chemo • ORR, DoR, PFS, OS, PK, ADA
• Arm B2: Imfinzi + danvatirsen + Investigator's choice of chemo
• Arm B3: Imfinzi + oleclumab + Investigator's choice of chemo
15Approved medicines
Oncology
Late-stage development
Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development
Other cancers, early disease
Trial Population Patients Design Endpoints Status
CVRM
Phase III Non-muscle invasive bladder 975 • Arm 1: BCG (Bacillus Calmette–Guérin) (Induction + Primary endpoints: • FPCD: Q3 2018
POTOMAC cancer maintenance) • DFS • Data anticipated: 2020+
• Arm 2: Imfinzi + BCG (Induction only)
NCT03528694 • Arm 3: Imfinzi + BCG (Induction + maintenance)
Phase III Muscle-invasive bladder 960 • Arm 1: Imfinzi in combination with gemcitabine + cisplatin, Coprimary endpoints: • FPCD: Q1 2019
cancer Imfinzi maintenance • pCR • Data anticipated: 2020+
NIAGARA • Arm 2: gemcitabine + cisplatin • EFS
Respiratory
Phase III Locoregional Hepatocellular 600 • Arm A: Transarterial Chemoembolization (TACE) in Primary endpoint • FPCD: Q1 2019
EMERALD-1 Carcinoma combination with Imfinzi PFS for Arm A vs Arm C • Data anticipated: 2020+
• Arm B: Transarterial Chemoembolization (TACE) in
NCT03778957 combination with Imfinzi + Bevacizumab Secondary endpoint
• Arm C: Transarterial Chemoembolization (TACE) in PFS for Arm B vs Arm C , OS
combination with Placebos
Phase III Adjuvant Therapy in 888 • Arm 1: Imfinzi + bevacizumab Primary endpoint: • Initiating
EMERALD-2 Hepatocellular Carcinoma • Arm 2: Imfinzi + placebo • RFS for Arm 2 vs Arm 3
• Arm 3: placebo + placebo
Secondary endpoint:
• RFS Arm 1 vs Arm 3, OS, RFS at 24
mos
Other
pCR = Pathologic Complete Response
EFS = event free survival
16Approved medicines
Oncology
Late-stage development
Imfinzi (PD-L1 mAb) +/- treme (CTLA-4 mAb) Early development
Other cancers, late disease
Trial Population Patients Design Endpoints Status
CVRM
Phase III Cis-eligible and ineligible 1,005 • Arm 1: Imfinzi + tremelimumab Primary endpoints: • FPCD: Q4 2015
DANUBE bladder cancer 1L • Arm 2: Imfinzi • OS • LPCD: Q1 2017
• Arm 3: SoC • Data anticipated: H2 2019
NCT02516241
Phase III Bladder cancer 1L 885 • Arm 1: Imfinzi + tremelimumab + SoC Primary endpoints: • FPCD: Q3 2018
NILE • Arm 2: Imfinzi + SoC • PFS • Data anticipated: 2020+
• Arm 3: SoC • OS
NCT03682068
Respiratory
Phase III HNSCC 1L 823 • Arm 1: Imfinzi Primary endpoints: • FPCD: Q4 2015
KESTREL • Arm 2: Imfinzi + tremelimumab • OS • LPCD Q1 2017
• Arm 3: SoC • Data anticipated: H2 2019
NCT02551159
Phase III Unresectable Hepatocellular 1,310 • Arm 1: Imfinzi + tremelimumab (Regimen 1) Primary endpoint: • FPCD: Q4 2017
HIMALAYA Carcinoma (HCC) 1L • Arm 2: Imfinzi + tremelimumab (Regimen 2) • OS • Data anticipated: 2020+
• Arm 3: Imfinzi Secondary endpoint:
NCT03298451 • Arm 4: sorafenib • PFS, time to tumour progression (TTP),
ORR
Phase II Urothelial bladder cancer 76 • Arm 1 tremelimumab (urothelial bladder cancer) Primary endpoint: • FPCD: Q4 2015
Other
triple-negative breast cancer • Arm 2 tremelimumab (triple-negative breast cancer) • ORR • Data readout: Q4 2018
pancreatic ductal- • Arm 3 tremelimumab (pancreatic ductal-adenocarcinoma)
NCT02527434 adenocarcinoma Secondary endpoints:
• Safety, DoR
Phase III Biliary Tract Carcinoma 474 • Treatment Arm 1 Durvalumab + Gemcitabine + Cisplatin Primary endpoint: • Initiating
TOPAZ-1 (BTC) 1L • Treatment Arm 2 Placebo + Gemcitabine + Cisplatin • OS
NCT03875235 Global trial Secondary endpoint:
• PFS, ORR, DoR
Phase III Locally Advanced Cervical 714 • Arm 1 Imfinzi + EBRT + brachytherapy with platinum Primary • FPCD: Q1 2019
CALLA Cancer • Arm 2 Placebo + EBRT + brachytherapy with platinum • PFS • Data anticipated: 2020+
Secondary
NCT03830866 Global trial • OS, PFS, CR rate, DoR, ORR, DoCR,
safety/tolerability, PRO, PK/ADA
pCR = Pathologic Complete Response
EFS = event free survival
17Approved 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: Imfinzi + tremelimumab • Data anticipated: 2020+
NCT03084471
Phase I Combination in Solid tumours 80 • Arm 2 Small cell lung cancer (SCLC). Imfinzi + tremelimumab • Safety • FPCD: Q1 2016
Advanced Solid Tumours + carboplatin + etoposide • LPCD: Q1 2019
• Arm 3 TNBC (triple-negative breast cancer): Imfinzi + • Data anticipated: 2020+
NCT02658214 tremelimumab + chemo
Respiratory
• Arm 4 TNBC: Imfinzi + tremelimumab + chemo
• Arm 5 Gastric/gastro-Oesophageal junction (GEJ): Imfinzi +
tremelimumab + oxaliplatin + 5-fluorouracil (5FU) + leucovorin
Arm 6 PDAC (pancreatic ductal adenocarcinoma): Imfinzi +
tremelimumab + chemo
• Arm 7 ESSC (esophageal squamous cell carcinoma): Imfinzi +
tremelimumab + chemo
Phase I Immunotherapy in Head and neck squamous- 300 • HNSCC Arm 1 • Safety • FPCD: Q2 2018
Combination With cell carcinoma (HNSCC), • NSCLC Arm 1 • Data anticipated: 2020+
Chemoradiation in Patients Non-small-cell lung cancer • NSCLC Arm 2
With Advanced Solid (NSCLC), Small-cell lung • NSCLC Arm 3
Tumours cancer (SCLC) • SCLC Arm 2
Other
• SCLC Arm 3
CLOVER • SCLC Arm 4
NCT03509012
Phase II mTNBC (metastatic triple 100 • Arm 1 Imfinzi + paclitaxel Primary endpoint: • FPCD: 1Q2019
BEGONIA negative breast cancer) 1L • Arm 2 Imfinzi + paclitaxel + capivasertib • Safety and tolerability • Data anticipated: 2020+
• Arm 3 Imfinzi + paclitaxel + selumetinib
NCT03742102 • Arm 4 Imfinzi + paclitaxel + danvatirsen Secondary endpoint:
• Arm 5 Imfinzi + paclitaxel + oleclumab • ORR, PFS, DoR, OS, PK, ADA
Global trial
18Approved 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 • FPCD: Q3 2013
SOLO-1 cancer 1L two years or until disease progression • Secondary endpoint: OS • LPCD: Q1 2015
• Arm 2: placebo • Data readout: Q2 2018
• Primary endpoint met
NCT01844986 Global trial
Phase III PSR gBRCAm ovarian cancer 266 • Arm 1: Lynparza 300mg BID to progression • Primary endpoint: ORR • FPCD: Q1 2015
SOLO-3 3L+ • Arm 2: physician’s choice (single-agent chemotherapy) • LPCD: Q2 2018
• Data readout: Q4 2018
Respiratory
NCT02282020 Global trial • Primary endpoint met
Phase III BRCAm adjuvant breast 1,800 • Arm 1: Lynparza 300mg BiD • Primary endpoint: invasive disease-free • FPCD: Q2 2014
OlympiA cancer 12 month duration survival (IDFS)
• Arm 2: placebo 12-month duration • Secondary endpoint: distant disease-
NCT02032823 free survival and OS
Global trial partnership with BIG and NCI/NRG
Partnered
Phase III BRCAm metastatic breast 302 • Arm 1: Lynparza 300mg BiD, continuous to progression • Primary endpoint: PFS • FPCD: Q2 2014
OlympiAD cancer • Arm 2: physician’s choice: • Secondary endpoint: OS • LPCD: Q4 2015
Other
capecitabine 2500mg/m2 x 14 q 21 • Data readout: Q1 2017
NCT02000622 vinorelbine 30mg/m2 d 1, 8 q 21 • Primary endpoint met
eribulin 1.4mg/m2 d 1, 8 q 21
to progression
Global trial
Phase III gBRCAm pancreatic cancer 154 • Arm 1: Lynparza tablets 300mg twice daily as maintenance • Primary endpoint: PFS • FPCD: Q1 2015
POLO therapy until progression • Secondary endpoint: OS • LPCD: Q1 2019
• Arm 2: placebo tablets BID • Data readout: Q1 2019
NCT02184195 • Primary endpoint met
Global trial
Phase III Metastatic castration-resistant 387 • Arm 1: Lynparza 300mg BID • Primary endpoint: radiologic PFS • FPCD: Q2 2017
PROfound prostate cancer • Arm 2: physician’s choice: • Secondary endpoints: ORR, Time to • LPCD: Q4 2018
HRRm, 2L+ enzalutamide 160mg once daily Pain Progression, OS • Data anticipated : H2 2019
NCT02987543 abiraterone acetate 1,000mg once daily
Global trial
19Approved 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: bevacizumab • PFS • Data anticipated: 2020+
DuO-O • Arm 2: bevacizumab + Imfinzi
• Arm 3: bevacizumab + Imfinzi + Lynparza
NCT03737643
tBRCAm patients
• bevacizumab (optional) + Imfinzi + Lynparza
Global trial
Respiratory
Phase II Stage IV NSCLC whose disease has 250 • Arm 1: Imfinzi + Lynparza Primary endpoint: • FPCD Q1 2019
not progressed following SoC chemo • Arm 2: Imfinzi + placebo • PFS • Data anticipated: 2020+
DuO-L + Imfinzi Maintenance therapy 1L
(ORION) Global trial
NCT03775486
Phase II Platinum-Ineligible unresectable 150 • Arm 1: Imfinzi + Lynparza • Primary endpoint: PFS • FPCD: Q1 2018
BAYOU Stage IV urothelial cancer • Arm 2: Imfinzi + placebo • Data anticipated : 2020
NCT03459846 Global trial
Other
Phase I / II gBRCAm ovarian cancer 2L+ 148 • Arm 1: Lynparza + Imfinzi Primary endpoints: • FPCD: Q2 2016
MEDIOLA gBRCAm HER2-negative breast • Dose until progression • DCR at 12 weeks • LPCD: Q2 2017
cancer 1-3L • Safety and tolerability
NCT02734004 Small cell lung cancer (SCLC) 2L+ Global trial
Gastric cancer 2L+
Phase I / II gBRCAm ovarian cancer 2L+ 140 • Arm 1: Lynparza + Imfinzi Primary endpoints: • FPCD: Q2 2018
MEDIOLA Non-gBRCAm ovarian cancer 2L+ • Arm 2: Lynparza + Imfinzi • DCR at 12 weeks
(Ovarian expansion) Non-gBRCAm ovarian cancer 2L+ • Arm 3: Lynparza + Imfinzi + bevacizumab • ORR
• Dose until progression • Safety and tolerability
NCT02734004
Global trial
Phase I / II HER2-negative BRCAm breast 140 • Arm 1: Lynparza + Imfinzi Primary endpoints: • Initiating
MEDIOLA cancer • DCR at 12 weeks
(Breast expansion) HER2-negative non-BRCA HRRm • Arm 2: Lynparza + Imfinzi • ORR
breast cancer • Safety and tolerability
NCT02734004 Non-HRRm triple negative breast • Arm 3: Lynparza + Imfinzi + bevacizumab
cancer • Dose until progression
Global trial
20Approved 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: Q2 2015
PAOLA-1 maintenance disease progression • PFS • LPCD: Q2 2018
• Arm 2: Placebo for two years or until disease progression • Data anticipated: H2 2019
NCT02477644
Externally sponsored Global trial
Phase III Metastatic castration-resistant 720 • Arm 1: Lynparza + abiraterone Primary Endpoint: • FPCD: Q4 2018
prostate cancer 1L • Arm 2: placebo + abiraterone • PFS • Data anticipated: 2020+
PROPEL Global trial
Respiratory
NCT 03732820
Phase II Triple-negative breast cancer 450 • Arm 1: AZD6738 + Lynparza • PFS • FPCD: Q2 2018
(TNBC) • Arm 2: adavosertib + Lynparza • ORR / OS • Data anticipated: 2020+
VIOLETTE • Arm 3: Lynparza • Safety and tolerability
Trial conducted in 15 countries: North America, Europe and Asia
Phase III Recurrent platinum sensitive 549 • Arm 1: chemotherapy Primary endpoint: • FPCD: Q1 2016
GY004 ovarian cancer • Arm 2: Lynparza • PFS • Data anticipated: 2020+
• Arm 3: cediranib + Lynparza
NCT02446600 Secondary endpoints:
Externally sponsored US/Canada/Japan sites • OS, QoL, safety
Other
Phase II/III Recurrent platinum 680 • Arm 1: chemotherapy Primary endpoints: • FPCD: Q2 2016
GY005 resistant/refractory ovarian • Arm 2: cediranib + Lynparza • PFS, OS • Data anticipated: 2020+
cancer • Arm 3: cediranib
NCT02502266 • Arm 4: Lynparza Secondary endpoints:
Externally sponsored • ORR, QoL, safety
• US/Canada sites
Phase II HRRm or HRD-positive 370 • Arm 1: Lynparza Primary endpoints: • FPCD: Q1 2019
LYNK-002 advanced cancer • ORR
Trial conducted in 15 countries worldwide
NCT03742895 Secondary endpoints:
Partnered • DOR, OS, PFS, AE, Prog by CA-125
21Approved medicines
Oncology
Late-stage development
Trastuzumab deruxtecan (DS-8201, HER2 ADC) Early development
Breast and gastric cancers
Trial Population Patients Design Endpoints Status
CVRM
Phase II HER2-positive, unresectable and/or 230 Randomised, open label, sequential assignment Primary endpoint ORR • FPCD: Q3 2017
DESTINY-Breast01 metastatic breast cancer subjects • Trastuzumab deruxtecan • Data anticipated: H2 2019
previously treated With trastuzumab Secondary end points DoR, CBR, CBR,
NCT03248492 emtansine PFS, OS
Partnered
Phase III HER2-positive, unresectable and/or 600 Randomised open label parallel assignment Primacy endpoint PFS • FPC Q3 2018
DESTINY-Breast02 metastatic breast cancer pretreated with • Trastuzumab deruxtecan • Data anticipated 2020+
Respiratory
prior standard of care HER2 therapies, Physicians choice of Secondary endpoints OS, ORR, DoR, CBR
NCT03523585 including trastuzumab emtansine • Lapatinib + capecitabine
Partnered • Trastuzumab + capecitabine
Phase III HER2-positive, unresectable and/or 500 Randomised open label parallel assignment Primary endpoint PFS • FPCD Q3 2018
DESTINY-Breast03 metastatic breast cancer subjects • Trastuzumab deruxtecan • Data anticipated 2020+
previously treated with trastuzumab and • Ado-trastuzumab emtansine Secondary endpoints OS, ORR, DoR,
NCT03529110 taxane CBR, PFS
Partnered
Other
Phase III HER2-low, unresectable and/or 540 Randomised open label parallel assignment Primary end point PFS • FPCD Q4 2018
DESTINY-Breast04 metastatic breast cancer subjects • Trastuzumab deruxtecan • Data anticipated 2020+
• Physicians choice of SoC chemo (choice of capecitabine, Secondary end points OS, DoR, ORR
NCT03734029 eribulin, gemcitabine, paclitaxel or nab-paclitaxel)
Partnered
Phase II HER2-overexpressing advanced gastric 220 Randomised open label parallel assignment Primary end point ORR • FPCD Q4 2017
DESTINY-Gastric01 or gastroesophageal junction • Trastuzumab deruxtecan • Data anticipated 2020
adenocarcinoma patients who have • SoC chemo Secondary end points PFS, OS, DoR,
NCT03329690 progressed on two prior treatment DCR, TTF, range of PK endpoints
Partnered regimens
22Approved medicines
Oncology
Late-stage development
Trastuzumab deruxtecan (DS-8201, HER2 ADC) Early development
Other cancers
Trial Population Patients Design Endpoints Status
CVRM
Phase II HER2-expressing advanced colorectal 90 Non randomised single group assignment Primary end point ORR • FPCD Q1 2018
cancer • Trastuzumab deruxtecan • Data anticipated 2020
NCT03384940 Secondary end points PFS, OS, DoR,
range of PK endpoints
Partnered
Phase II HER2-over-expressing or mutated, 80 Non randomised parallel group assignment Primary end point ORR • FPCD Q2 2018
unresectable and/or metastatic NSCLC • Trastuzumab deruxtecan • Data anticipated 2020
Respiratory
NCT03505710 Secondary end points DoR, PFS, OS
Partnered
Phase I Advanced solid malignant tumours 278 Non randomised single group assignment Primary end points number of subjects with • FPCD Q3 2015
• Trastuzumab deruxtecan Aes, tumour response • Data read out Q2 2018
NCT02564900
Secondary end points PK
Partnered
Other
23Approved 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
ACE-CL-007 (ELEVATE-TN) lymphocytic leukaemia (CLL) • Arm B: Calquence + obinutuzumab B) • Data anticipated: H2 2019
• Arm C: Calquence • Secondary endpoints: IRC (independent
NCT02475681 review committee) assessed ORR, OS
(Arm A vs. Arm B vs. Arm C)
Phase III Previously untreated CLL 780 • Arm A; Calquence + venetoclax (AV) • Primary - AV vs FCR/BR efficacy PFS • FPCD: Q1 2019
fit • Arm B: Calquence + venetoclax + obinutuzumab (AVG) • Secondary AVG vs FCR/BR efficacy • Data anticipated: 2020+
ACE-CL-311 • Arm C: fludarabine + cyclophosphamide + rituxumab (FCR) PFS; AV vs FCR/BR and AVG vs
Respiratory
OR bendamustine + rituximab (BR) FCR/BR
Phase III Relapsed/refractory CLL 306 • Arm A: Calquence • Primary endpoint: IRC assessed PFS • FPCD Q3 2016
ACE-CL-309 (ASCEND) • Arm B: rituximab + idelalisib or bendamustine (investigator’s (arm A vs. Arm B) • Data anticipated: H2 2019
NCT02970318 choice) • Secondary endpoints: INV-assessed
ORR, OS, DoR, patient reported
outcomes (PROs)
Phase III Relapsed/refractory high risk 533 • Arm A: Calquence • Primary endpoint: PFS • FPCD: Q2 2015
ACE-CL-006 (ELEVATE-RR) CLL • Arm B: ibrutinib • Secondary endpoints: comparison of • Data anticipated: 2020+
incidence of infections, RTs (Richter’s
NCT02477696 Transformation) and atrial fibrillation, OS
Other
Phase III Previously untreated mantle 546 • Arm A: Calquence + bendamustine + rituximab • Primary endpoint: PFS by Lugano • FPCD: Q1 2017
ACE-LY-308 cell lymphoma (MCL) • Arm B: bendamustine + rituximab Classification for non-Hodgkin's • Data anticipated: 2020+
Lymphoma (NHL)
NCT02972840 • Secondary endpoints: Investigator-
assessed (IA) PFS, ORR; IRC-assessed
ORR, DoR, time to response; OS
Phase II Relapsed/ refractory CLL, 60 Calquence monotherapy • ORR at 36 cycles • FPCD: Q1 2016
ACE-CL-208 intolerant to ibrutinib • Data anticipated: 2020
NCT02717611
Phase II Relapsed/refractory and 48 Calquence monotherapy • ORR • FPCD: Q4 2014
15-H-0016 treatment naïve/del17p • Arm A: Lymph node biopsy • Data anticipated: 2020+
CLL/small lymphocytic • Arm B: Bone marrow biopsy
NCT02337829 lymphoma (SLL)
Phase I/II CLL/SLL/Richter's 286 Calquence monotherapy • Safety, PK, PD • FPCD: Q1 2014
ACE-CL-001 transformation (RT) Dose escalation and expansion • Data anticipated: 2020+
NCT02029443
24Approved 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 Calquence and ACP-319 (Pi3K inhibitor) • ORR • Data anticipated: 2020
NCT02328014
Phase I/II Haematological Malignancies 159 Calquence + pembrolizumab • Safety • FPCD: Q1 2015
ACE-LY-005 • Secondary endpoints: ORR, DoR, PFS, • Data anticipated: 2020+
OS, TTNT (time to next therapy)
NCT02362035
Respiratory
Phase I/II Waldenstrom 106 Calquence monotherapy • ORR • FPCD: Q3 2014
ACE-WM-001 Microglobulinaemia • Data readout: Q1 2018
NCT02180724
Phase Ib Relapsed/refractory de novo 21 Calquence monotherapy • Safety • FPCD: Q3 2014
ACE-LY-002 activated B-cell diffuse large • Data anticipated: H2 2019
B-cell lymphoma (DLBCL)
NCT02112526
Phase Ib Mantle Cell Lymphoma (MCL) 76 Calquence in combination with bendamustine and rituximab • Safety • FPCD: Q1 2016
ACE-LY-106 • Arm A: Treatment naive • Data anticipated: 2020+
• Arm B: Relapsed/refractory
Other
NCT02717624 • Arm C: Treatment naïve: Calquence+venetoclax+Rituxan
Phase Ib Relapsed/refractory Multiple 28 • Arm A: Calquence • Safety • FPCD: Q1 2015
ACE-MY-001 Myeloma • Arm B: Calquence + dexamethasone • Data readout: Q4 2018
NCT02211014
Phase I Relapsed/refractory Follicular 126 • Arm A: Calquence • Safety • FPCD: Q1 2015
ACE-LY-003 Lymphoma • Arm B: Calquence + rituximab • Data anticipated: 2020+
NCT02180711
Phase I Relapsed/refractory CLL/ 12 Calquence in combination with ACP-319 • Safety, PK, PD • FPCD: Q3 2014
ACE-CL-002 small lymphocytic lymphoma Dose escalation • Data anticipated: 2020
(SLL)
NCT02157324
Phase I CLL/SLL/Prolymphocytic 69 Calquence + obinutuzumab • Safety, ORR • FPCD: Q4 2014
ACE-CL-003 Leukaemia (PLL) • Arm A: Relapsed/refractory • Secondary endpoints: PD, PFS, TTNT, • Data anticipated: 2020+
• Arm B: Treatment naïve OS
NCT02296918
Calquence + venetoclax + rituxumab
25 • Arm C: Relapsed/refractory
• Arm D: Treatment naïveApproved 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 25 • Calquence monotherapy • Safety • FPCD: Q2 2017
Advanced B-cell Malignancies • Dose confirmation and expansion • Data anticipated: 2020+
NCT03198650
Phase I/II CLL (chronic lymphocytic 62 • Arm A: AZD6738 monotherapy • Identify dose of AZD 6738 and safety of FPCD: Q1 2018
CL-110 leukaemia) R/R • Arm B: Calquence + AZD6738 co-administration of Calquence + Data anticipated: H1 2020
AZD6738
Respiratory
NCT03328273
Phase I/II B-cell malignancies R/R 25 Part 1: Calquence daily + vistusertib daily • MTD and optimal dosing schedule FPCD: Q3 2017
LY-110 Part 2: Calquence daily + vistusertib 5 days on/2 days off • Safety Data anticipated: 2020
NCT03205046
Other
26Approved 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: Calquence + pembrolizumab • Data readout: Q2 2018
carcinoma (HNSCC)
NCT02454179
Phase II ≥ 2L advanced or metastatic 74 • Arm A: pembrolizumab • ORR • FPCD: Q2 2015
ACE-ST-007 Non-small-cell lung cancer • Arm B: Calquence + pembrolizumab • Data readout: 2017
(NSCLC)
NCT02448303
Respiratory
Phase II Recurrent ovarian cancer 76 • Arm A: Calquence • ORR • FPCD: Q4 2015
ACE-ST-208 • Arm B: Calquence + pembrolizumab • Data readout: Q3 2018
NCT02537444
Phase II ≥ 2L advanced or metastatic 73 • Arm A: Calquence • Safety • FPCD: Q2 2015
ACE-ST-003 pancreatic cancer • Arm B: Calquence + pembrolizumab • Data readout: Q3 2017
NCT02362048
Phase II Platinum-resistant urothelial 75 • Arm A: pembrolizumab • ORR • FPCD: Q2 2015
ACE-ST-005 bladder cancer • Arm B: Calquence + pembrolizumab • Data readout: Q1 2018
Other
NCT02351739
Phase Ib/II ≥ 2L glioblastoma multiforme 52 • Arm A: Calquence 200mg BID • Safety, ORR • FPCD: Q1 2016
ACE-ST-209 • Arm B: Calquence 400mg QD • Data anticipated: H1 2019
NCT02586857
27Approved 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: • Complete partial and complete response • FPCD: Q3 2015
SPRINT type 1 (NF1) • Stratum 1: PN related morbidity present at enrolment rate measured by volumetric MRI; • LPCD: Q4 2016
• Stratum 2: No PN related morbidity present at enrolment • Duration of response and functional • Data readout: Q1 2019
NCT01362803 outcomes/QoL
Partnered
Phase Ib Advanced solid tumours 80 (dose escalation Phase Ib open-label trial of MK-8353 in combination with • Dose-limiting toxicities (DLTs) • FPCD: Q1 2019
Selumetinib + MK-8353 (ERK trial) selumetinib in participants with advanced solid tumours • Adverse Events (AEs)
Respiratory
inhibitor) • Study drug discontinuations due to an
AE
NCT03745989
Partnered (Merck Lead
study)
Other
28Approved medicines
Oncology
Late-stage development
Savolitinib (MET inhibitor) Early development
Papillary renal cell, NSCLC 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 2017
cell cancer • Arm 2: sunitinib 50mg QD (4 weeks on / 2 weeks off) • Secondary endpoints include ORR, DoR • Data anticipated: 2020
NCT03091192 and OS
Global trial
Partnered
Phase I Advanced cancer ~70 • Dose escalation trial • Safety and tolerability • FPCD: Q2 2013
(all comers) • Data anticipated: 2020+
NCT01985555 Conducted in China
Respiratory
Partnered
Phase I NSCLC 64 • Dose escalation trial • Safety and tolerability • FPCD: Q2 2015
• Data readout: Q4 2018
NCT02374645 Conducted in China
Other
Phase II Lung Pulmonary Sarcomatoid 92 • Single arm trial: savolitinib 600mg QD • ORR • FPCD: Q1 2017
Carcinoma (PSC) and other • Data anticipated: 2020+
NCT02897479 NSCLC Conducted in China
Partnered
29Approved 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 30mg + Lynparza 200mg bd • ORR DoR, DCR, QoL. OS; Safety • FPCD: Q1 2017
CONCERTO (PRR) ovarian cancer - heavily • LPCD: Q1 2019
pre-treated BRCAwt
NCT02889900
Respiratory
Other
30AstraZeneca Oncology – early-stage development
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 2017
if [11C]AZD1390 crosses the blood brain • Data anticipated: H2 2019
NCT03215381 • [11C]AZD1390 microdose administered by IV bolus barrier in healthy volunteers
Trial conducted in a single centre in Sweden
Phase I Recurrent Glioblastoma c. 132 • Primary: Investigate the safety, • FPCD Q2 2018
eligible for re-irradiation, brain • Designed to evaluate the safety, tolerability and PK of tolerability, and MTD of AZD1390 • Data anticipated: 2020+
NCT03423628 metastases and AZD1390 in combination with radiation therapy in patients with administered in combination with radiation
Respiratory
leptomeningeal disease, GBM and brain metastases from solid tumours therapy in brain malignancies
newly-diagnosed
glioblastoma patients • Dose and schedule of AZD1390 administration will be
adjusted during assessment of safety and tolerability during this
Phase I trial
Conducted across seven sites in USA and UK
Other
32Approved 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 + adavosertib • Primary endpoint: ORR • FPCD: Q1 2015
ovarian cancer • Arm C: carboplatin + adavosertib • LPCD: Q2 2018
NCT02272790 • Secondary endpoints: DoR, PFS, OS,
Global trial Disease Control Rate, safety and
tolerability
Phase I Advanced solid tumours 102 • Dose escalation trial to determine MTD (adavosertib + • Safety and tolerability • FPCD: Q3 2015
Lynparza) followed by an expansions in SCLC • Secondary endpoints: Overall response
NCT02511795 rate, Disease Control Rate, Duration of
Respiratory
Conducted in US, Canada Response, PFS
Phase I Advanced solid tumours 55 • Dose escalation trial to determine MTD (adavosertib + Imfinzi) • Safety and tolerability • FPCD: Q4 2015
NCT02617277 Conducted in US
Phase I Advanced solid tumours 30 Part A: caffeine (200mg), omeprazole (20mg) and midazolam • Primary endpoints: • FPCD: Q4 2017
(1mL of 2mg/mL syrup) followed 7-14 days later by adavosertib • Part A: Plasma AUC, AUC0-t and CMAX
D6014C00006 225mg bid for 2.5 days plus caffeine (200mg), omeprazole for cocktail parent compounds
(20mg) and midazolam (1mL of 2mg/mL syrup) on day 3. (midazolam, omeprazole and caffeine)
NCT03333824 Part B: 7-14 days after end of Part A, adavosertib 225mg BID for • Part B: dECG (Differentiated ECG)
2.5 days. intervals (QTcF) for absolute values and
time-matched change from baseline
Conducted in US
Other
Phase I Advanced solid tumours 54 adavosertib monotherapy once daily. • Safety and tolerability • FPCD: Q4 2017
D6014C00007 Conducted in US and Europe
NCT03313557
33Approved 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 tolerability • Data anticipated: H2 2019
cancers with PIK pathway & F) fulvestrant [initially 12 patients per arm with option to expand to • ORR
NCT01226316 mutation 24 patients in one or more arms] • Clinical Benefit Rate at 24 weeks
• Part E arm 1: ER+ Breast with AKT-1 mutation (prior Faslodex (CBR24)
resistance) [Parts E & F only]
• Part E arm 2: ER+ Breast with AKT-1 mutation (first exposure
to Faslodex)
• Part F arm 1: ER+ Breast with PTEN mutation (prior Faslodex
resistance)
Respiratory
• Part F arm 2: ER+ Breast with PTEN mutation (first exposure to
Faslodex)
Phase II (ESR) Advanced / metastatic triple 140 Randomised comparative • Progression Free Survival • Data readout: Q2 2018
negative breast cancer ARM1: Paclitaxel + capivasertib • Overall survival • Final OS data awaited
NCT02423603 receiving 1L chemotherapy ARM 2: Paclitaxel + placebo
with paclitaxel Overall population and in sub-group with
PAKT tumours harbouring PIK3CA/AKT1/PTEN
alterations
Phase II (ESR) Post menopausal women with 140 Randomised comparative • Progression Free Survival • Data anticipated: H1 2019
Other
advanced ER+/Her2- breast ARM 1: Faslodex + capivasertib • Overall survival
NCT01992952 cancer previously treated with ARM 2: Faslodex + placebo
aromatase inhibition Overall population and sub-group with
FAKTION activation of the tumour PI3K/Akt/PTEN
pathway (eg. PIK3CA/AKT1/PTEN
alterations)
Phase II (ESR) Metastatic castration resistant 150 Randomised comparative • Progression Free Survival • Data anticipated: 2020
prostate cancer eligible for ARM 1: Docetaxel + prednisolone + capivasertib
NCT02121639 treatment with docetaxel ARM 2: Docetaxel + prednisolone + placebo
chemotherapy
PROCAID
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