H1 2018 Clinical Trials appendix

115 Pages·2017·4.81 MB·English

Clinical Trials Appendix
Q2 2018 results update
The following information about AstraZeneca clinical trials in Phases I-IV has been
created with selected information from https://clinicaltrials.gov to facilitate
understanding of key aspects of ongoing clinical programmes and is correct to the
best of the Company’s knowledge as of 30 June 2018, 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 (https://clinicaltrials.gov)
2
List of abbreviations
ADA Anti-Drug Antibody ICS Inhaled Corticosteroid pMDI Pressurised Metered Dose Inhaler
ADC Antibody-Drug Conjugate IM IntraMuscular PoC Proof of Concept
AE Adverse Event IR Immediate Release PR Partial Response
AUC Area Under Curve IV Intravenous Q2W Quaque(every) TwoWeeks
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) EightWeeks
CNS Central Nervous System LPCD Last Patient Commenced Dosing QD QuaqueDie (one time a day)
DCR Disease Control Rate MAD Multiple Ascending Dose QOD QuaqueAltera 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 MolecularEntity 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
Homologous Recombination Repair PFS Progression-Free Survival
HRRm
mutation
PK Pharmacokinetics
3
Table of contents slide
Early development -IMED
(AstraZeneca research & early development)
Movement since Q12018 results announcement Oncology
Q2 2018 NME pipeline CVRM
Q2 2018 LCM pipeline Respiratory
Other
Approved medicines
Oncology
Early development -MedImmune
Cardiovascular, Renal & Metabolism (CVRM)
Oncology
Respiratory
CVRM
Other
Respiratory
Other
Late-stage pipeline
Oncology
CVRM
Respiratory
Other
4
Movement since Q1 2018 update
New to Phase I New to Phase II New to Pivotal Study New to Registration
NMEs Life-cycle Management Life-cycle management
MEDI5752 Imfinzi+CRTPACIFIC-2 saxagliptin/dapagliflozin/metformin [EU] 1
PD-1/CTLA-4 bispecific mAbsolid tumours PD-L1 mAblocally-advanced (stage III) NSCLC DPP-4 inhibitor/SGLT2 inhibitor type-2 diabetes
MEDI2228
BCMA antibody drug conjugate multiple myeloma
Additional indications
oleclumab+AZD4635
CD73 mAb+ A2aR inhibitor EGFRmNSCLC
Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration
NME Life-cycle Management NME
MEDI4276 TagrissoBLOOM 3 lanabecestat#AMARANTH, DAYBREAK-ALZ
HER2 bispecific antibody drug conjugate solid tumours EGFR inhibitorCNS metastasesin advancedEGFRmNSCLC beta-secretase inhibitor alzheimer’sdisease
Additional indication
selumetinib#ASTRA
MEK inhibitor differentiated thyroid cancer
¶ Registrational Phase II/III study
# Partnered and/or in collaboration
1Submission Accepted 2 Submission Approved 3 Completed
5
Q2 2018 New Molecular Entity (NME)1 Pipeline
Phase I Phase II Phase III Applications Under Review
30 Projects 27 Projects 7 Projects 2 Projects
Small molecule Large molecule Small molecule Large molecule Small molecule Small molecule
AZD0156 Imfinzi#+monalizumab# adavosertib# abediterol# Imfinzi#+MEDI0457# Lynparza#¶+cediranib CONCERTO roxadustat#
ATM solid tumours PD-L1+NKG2a solid tumours (AZD1775)+chemotherapy LABA asthma/COPD PD-L1+DNA HPV vaccine HNSCC PARP+VEGF recurrent Pt-R ovarian HIFPH anaemia CKD/ESRD
AZD1390 MEDI0562# AZD2811# AZD1419# Imfinzi#+MEDI0680 savolitinib# SAVOIR Large molecule
glioblastoma hOX40 solid tumours aurora solid tumours inhaled TLR9 asthma PD-L1+PD-1 solid tumours MET pRCC
moxetumomab pasudotox# PLAIT
CD22 3L HCL
AZD4573 MEDI1873 AZD4547 AZD7594 MEDI0382 selumetinib# SPRINT
CDK9 haematalogical malignancies GITR solid tumours FGFR solid tumours inhaled SGRM asthma/COPD GLP-1/glucagon type-2 diabetes MEK paediatric neurofibromatosis type-1
AZD4635 MEDI2228 AZD6738 AZD7986# MEDI5884# PT010
A2aR inhibitor solid tumours BCMA ADC multiple myeloma ATR solid tumours DPP1 COPD cholesterol modulation cardiovascular LABA/LAMA/ICS COPD
AZD4785 MEDI3726# AZD8186 AZD8871# MEDI6012 Large molecule
KRAS solid tumours PSMA prostate PI3Kβ solid tumours MABA COPD LCAT cardiovascular
Imfinzi#+tremelimumab MYSTIC
PD-L1+CTLA-4 1L NSCLC
AZD5153 MEDI5083 capivasertib (AZD5363)# AZD9567 MEDI3902
BRD4 solid tumours CD40 ligand fusion protein solid AKT breast cancer SGRM RA/respiratory Psl/PcrV Pseudomonas pneumonia
tezepelumab# NAVIGATOR SOURCE
AZD5991 MEDI5752 Imfinzi#+AZD5069 or MEDI8852 TSLP severe uncontrolled asthma
MCL1 haematalogical malignancies PD-1/CTLA-4 solid tumours Imfinzi#+danvatirsen#(AZD9150) influenza A treatment
PD-L1+(CXCR2 or STAT3) HNSCC anifrolumab# TULIP
type I IFN receptor SLE
AZD9496 MEDI7247 vistusertib MEDI8897#
SERD ER+ breast antibody drug conjugate haems mTOR 1/2 solid tumours passive RSV prophylaxis
MEDI9197# oleclumab AZD5718 prezalumab#
TLR 7/8 solid tumours CD73 solid tumours FLAP coronary artery disease primary Sjögren’s syndrome
AZD4831 MEDI7219 AZD8601# suvratoxumab
MPO HFpEF anti-diabetic type-2 diabetes VEGF-A cardiovascular α-Toxin Staphylococcus pneumonia
AZD9977 MEDI3506 verinurad
MCR cardiovascular IL-33 COPD URAT-1 chronic kidney disease
AZD1402# MEDI0700#
inhaled IL-4Ra asthma BAFF/B7RP1 SLE
AZD5634 MEDI1341
inhaled ENaC cystic fibrosis alpha synuclein parkinson's disease
1Includes significant fixed-dose combination projects, and parallel indications that are in a separate therapy area
AZD7594+abediterol# MEDI1814# (See LCM chart for other parallel indications and oncology combination projects)
inhaled SGRM+LABA asthma/COPD amyloidβ alzheimer's disease # Partnered and/or in collaboration; ¶Registrational P2/3 study
AZD0284 MEDI7352
6RORg psoriasis/respiratory NGF/TNF osteoarthritis pain Oncology Cardiovascular, Renal & Metabolism Respiratory Other
Q2 2018 Lifecycle Management (LCM)1 Pipeline
Phase I Phase II Phase III Applications Under Review
0 Projects 7 Projects 21 Projects 5 Projects
Small molecule Small molecule Large molecule Small molecule Large molecule
Calquence# Calquence# Brilinta/BriliqueTHALES Imfinzi# PEARL (China) BydureonEXSCEL
BTK+ATR haematalogical malignancies BTK inhibitor 1st line MCL P2Y12 stroke PD-L1 1L NSCLC outcomes
Brilinta/BriliqueHESTIA Calquence# Brilinta/BriliqueTHEMIS Fasenra# Farxiga/Forxiga
P2Y12 paeds w/ sickle cell BTK inhibitor 1st line CLL P2Y12 diabetes & CAD outcomes IL-5R COPD type-1 diabetes
PT010 Calquence# EpanovaSTRENGTH Fasenra# OSTRO saxagliptin/dapagliflozin metformin
LABA/LAMA/ICS asthma BTK inhibitor r/r CLL, high risk outcomes IL-5R nasal polyposis DPP-4 type-2 diabetes
Large molecule Calquence# Farxiga/Forxiga linaclotide# (CN only)
BTK inhibitor r/r CLL SGLT2 heart failure IBS-c
Imfinzi#
PD-L1 solid tumours
Lynparza#OlympiA Farxiga/Forxiga Nexium(CN only)
PARP gBRCA adjuvant breast SGLT2 CKD stress ulcer prophylaxis
tezepelumab#
TSLP atopic dermatitis
Lynparza#POLO Farxiga/Forxiga DECLARE
PARP pancreatic cancer outcomes
anifrolumab#
type I IFN receptor SLE SC
Lynparza#PROfound roxadustat#
PARP prostate cancer HIFPH anaemia MDS
anifrolumab#
type I IFN receptor lupus nephritis
Lynparza#SOLO-1 SymbicortSYGMA
PARP 1L BRCAm ovarian ICS/LABA mild asthma
Lynparza#SOLO-3
PARP BRCAm PSR ovarian

TagrissoADAURA
EGFR adj. EGFRm NSCLC
1Includes significant LCM projects and parallel indications for assets in P3 or beyond. Excludes LCM projects
already launched in a major market
# Partnered and/or in collaboration; ¶Registrational P2/3 study
7 Oncology Cardiovascular, Renal & Metabolism Respiratory Other
Q2 2018 Lifecycle Management (LCM)1 Pipeline
Oncology Combinations
Phase I Phase II Phase III Applications Under Review
17 Projects 6 Projects 8 Projects 0 Projects
Large molecule
Calquence#+AZD6738 Imfinzi#+oleclumab Imfinzi#+tremelimumab Imfinzi#+tremelimumab DANUBE
BTK+ATR haematalogical tumours PD-L1+CD73 solid tumours PD-L1+CTLA-4 gastric cancer PD-L1+CTLA-4 1L bladder
Calquence#+vistusertib Imfinzi#+RT (platform) CLOVER Imfinzi#+tremelimumab Imfinzi#+tremelimumab EAGLE
BTK+mTor haematalogical tumours PD-L1+RT HNSCC NSCLC SCLC PD-L1+CTLA-4 biliary tract oesophageal PD-L1+CTLA-4 2L HNSCC
Imfinzi# or Imfinzi#+(treme or danvatirsen# Imfinzi#+tremelimumab Imfinzi+Lynparza# BAYOU Imfinzi#+tremelimumab HIMALAYA
PD-L1 or PD-L1+(CTLA-4 or STAT3) DLBCL PD-L1+CTLA-4 solid tumours PD-L1+PARP bladder PD-L1+CTLA-4 1L HCC
Imfinzi#+adavosertib# Imfinzi#+tremelimumab+chemo Lynparza#+AZD6738 Imfinzi#+tremelimumab KESTREL
PD-L1+Wee1 solid tumours PD-L1+CTLA-4 1L PDAC oesophageal SCLC PARP+ATR gastric PD-L1+CTLA-4 1L HNSCC
Imfinzi#+azacitidine# Imfinzi+selumetinib# Lynparza#+ImfinziMEDIOLA Imfinzi#+tremelimumab NEPTUNE
PD-L1+azacitidine MDS PL-L1 solid tumours + MEK inhibitor PARP+PD-L1 solid tumours PD-L1+CTLA-4 1L NSCLC
Imfinzi#+dabrafenib+trametinib Lynparza#+adavosertib# Tagrissocombo# TATTON Imfinzi#+tremelimumab+SoC CASPIAN
PD-L1+BRAF+MEK melanoma PARP+Wee1 solid tumours EGFR+PD-L1/MEK/MET NSCLC PD-L1+CTLA-4+SoC 1L SCLC
Imfinzi#+Iressa oleclumab + AZD4635 Imfinzi#+tremelimumab+SoC POSEIDON
PD-L1+EGFR NSCLC CD73+A2aR EGFRm NSCLC PD-L1+CTLA-4+SoC 1L NSCLC
Imfinzi#+MEDI0562# tremelimumab+MEDI0562# Imfinzi+CRT PACIFIC-2
PD-L1+hOX40 solid tumours CTLA-4+hOX40 solid tumours PD-L1+CRT NSCLC
Imfinzi#+MEDI9197#
PD-L1+TLR 7/8 agonist
1Includes significant LCM projects and parallel indications for assets in P3 or beyond. Excludes LCM projects
already launched in a major market
# Partnered and/or in collaboration; ¶Registrational P2/3 study
8 Oncology Cardiovascular, Renal & Metabolism Respiratory Other
Estimated key regulatory submission acceptances
timeline
Epanova
anifrolumab tezepelumab(NAVIGATOR)
roxadustat(US) Lokelma(JP) savolitinib
PT010 -COPD selumetinib-NF-1 Imfinzi+ treme(DANUBE) Lynparza+ cediranib
E
M Bevespi-COPD (JP) Imfinzi+ treme(KESTREL) Imfinzi+ treme(POSEIDON) Imfinzi+ treme(CASPIAN)
N
Imfinzi+ treme(MYSTIC) Imfinzi+ treme(EAGLE) Imfinzi+ treme(NEPTUNE) Imfinzi+ treme(HIMALAYA)
H2 2018 H1 2019 H2 2019 2019+
Lynparza(SOLO-1) Farxiga(DECLARE) Lynparza(POLO) Imfinzi(PACIFIC-2)
M
Farxiga/Onglyza/metformin Calquence-CLL Lynparza(PROfound)
C
L
Duaklir-COPD (US) Brilinta(THEMIS) Lynparza(OlympiA)
Tagrisso (ADAURA)
Brilinta(THALES)
Farxiga-outcomes
Fasenra(OSTRO)
9 Oncology Cardiovascular, Renal & Metabolism Respiratory Other
AstraZeneca
Approved medicines