Clinical trials appendix
Q1 2021 results update
Movement since Q4 2020 update
New to Phase I | New to Phase II | New to Pivotal trial | New to registration |
NME | |||
camizestrant (AZD9833) + palbociclib SERENA-4 | |||
selective oestrogen receptor degrader + CDK4/6 inhibitors | |||
1st-line HR+ HER2- breast cancer | |||
datopotamab deruxtecan# TROPION-Lung01 | |||
TROP2 targeting antibody drug conjugate | |||
2L+ NSCLC without actionable genomic mutations | |||
Lifecycle Management | |||
Enhertu# (platform) DESTINY-Breast07 | |||
HER2 targeting antibody drug conjugate HER2+ breast cancer | |||
Enhertu# (platform) DESTINY-Breast08 | |||
HER2 targeting antibody drug conjugate HER2low breast cancer | |||
Fasenra FJORD | |||
IL-5R mAb bullous pemphigoid | |||
Removed from Phase I | Removed from Phase II | Removed from Phase III | Removed from registration |
NME | NME | ||
AZD8154 | Lynparza# + ceralasertib VIOLETTE | ||
Inhaled PI3Kgd asthma | PARP inhibitor + ATR inhibitor breast cancer | ||
Calquence + ceralasertib | MEDI6012 | ||
BTK inhibitor + ATR inhibitor haematological malignancies | LCAT cardiovascular disease | ||
MEDI2228 | |||
BCMA antibody drug conjugate multiple myeloma | |||
- Phase progressions based on first patient dose achievement.
¶ Registrational Phase II/III trial # Partnered and/or in collaboration
Q1 2021 new molecular entity (NME)1 pipeline
Phase I
19 New Molecular Entities
Phase II
21 New Molecular Entities
Phase III | Under Review | |
12 New Molecular Entities | 0 New Moelcular Entities |
AZD0466#
BCL2/xL haematological and solid tumours
AZD1390 glioblastoma
AZD4573
CDK9 haematological malignancies
AZD5305
PARP1Sel solid tumours
AZD5991
MCL1 haematological malignancies
AZD7648#
DNAPK solid and haematological tumours
AZD8701
FOXP3 solid tumours
Calquence (platform) PRISM
BTK + multiple novel onc therapies r/r aggressive NHL
Imfinzi#+adavosertib#
PD-L1+Wee1 solid tumours
Imfinzi#+RT (platform) CLOVER PD-L1+RT HNSCC NSCLC SCLC
Imfinzi#+tremelimumab
PD-L1+CTLA-4 solid tumours
Imfinzi#+tremelimumab+chemo PD-L1+CTLA-4 1L PDAC oesophageal
SCLC
Imfinzi+selumetinib#
PD-L1+MEK solid tumours
IPH5201#
CD39 solid tumours
MEDI1191
IL12 mRNA solid tumours
MEDI5395
rNDV GMCSF solid tumours
MEDI5752+Axitinib PD-1/CTLA-4+VEGF advanced renal cell carcinoma
MEDI9253
rNDV IL12 solid tumours
Tagrisso combo# TATTON EGFR+MEK/MET advanced EGFRm
NSCLC
adavosertib#
Wee1 ovarian / uterine serous / solid tumours
AZD2811 nanoparticle
Aurora solid tumours, haematological malignancies
camizestrant SERD ER+ breast
capivasertib# AKT prostate
ceralasertib
ATR solid tumours
Imfinzi (platform) HUDSON PD-L1+multiple novel ONC therapies post
IO NSCLC
Imfinzi# (platform) BALTIC
PD-L1+CTLA-4, WEE1+Carboplatin,
ATR+PARP ES-SCLC R/R
Imfinzi# (platform) COAST PD-L1+multiple novel ONC therapies
NSCLC
Imfinzi# (platform) NeoCOAST PD-L1+multiple novel ONC therapies
NSCLC
Imfinzi# + imaradenant# + cabazitaxel PD-L1+A2aR+CTx prostate cancer
Imfinzi#+Lynparza# ORION
PD-L1+PARP 1L mNSCLC
Imfinzi#+MEDI0457# PD-L1+DNA HPV vaccine HNSCC
Imfinzi#+monalizumab#
PD-L1+NKG2a solid tumours
Imfinzi#+tremelimumab PD-L1+CTLA-4 biliary tract oesophageal
Imfinzi#+tremelimumab
PD-L1+CTLA-4 gastric cancer
Imfinzi+FOLFOX+bevacizumab (platform) COLUMBIA1 PD-L1+chemo+VEGF+multiple novel ONC therapies 1L MSS-CRC
Imfinzi+Lynparza# BAYOU
PD-L1+PARP bladder
MEDI5752
PD-1/CTLA-4 solid tumours
oleclumab+chemo or Imfinzi#+oleclumab+ chemo CD73+chemo or PDL1+CD73+chemo pancreatic
Post-1LTagrisso (platform) ORCHARD EGFR+multiple novel ONC therapies EGFRm NSCLC
Tagrisso+savolitinib# SAVANNAH EGFR+MET advanced EGFRm NSCLC
camizestrant+palbociclib SERENA-4 SERD+CDK4/6 1L HR+ HER2- breast cancer
capivasertib#+abiraterone CAPItello-281 AKT+abiraterone PTEN deficient metastatic hormone sensitive prostate cancer
capivasertib#+fulvestrant CAPItello-291 AKT+fulvestrant locally-advanced (inoperable) or metastatic breast
capivasertib+chemotherapy CAPItello-290 AKT+chemotherapy mTNBC 1L
datopotamab deruxtecan# TROPION- Lung01 TROP2 2L+ NSCLC without actionable mutation
Imfinzi#+/-tremelimumab+chemo
POSEIDON
PD-L1+/-CTLA-4+SoC 1L NSCLC
Imfinzi#+/-tremelimumab+CRT ADRIATIC PD-L1+/-CTLA-4+CRTLS-SCLC
Imfinzi#+tremelimumab HIMALAYA PD-L1+CTLA-4 1L HCC
Imfinzi#+tremelimumab+SoC NILE PD-L1+CTLA-4+SoC 1L urothelial cancer
Lynparza#+Imfinzi# DUO-E
PARP+PD-L1 1L endometrial cancer
Lynparza#+Imfinzi#+bevacizumab DUO-O PARP+PD-L1+VEGF1L ovarian
monalizumab#+cetuximab (INTERLINK-1) NKG2a+EGFR 2L+ relapsed metastatic
Phase progressions based on first patient dose achievement. | ||
3 | 1 Includes novel combinations and additional indications for assets where the lead is not yet launched. | Oncology |
# Partnered and/or in collaboration; ¶ Registrational Phase II/III trial |
HNSCC
Precision medicine approach being explored
Q1 2021 new molecular entity (NME)1 pipeline
Phase I
13 New Molecular Entities
Phase II
20 New Molecular Entities
Phase III
5 New Molecular Entities
AZD0284
RORg psoriasis / respiratory
AZD0449
Inhaled JAK inhibitor asthma
AZD1402#
inhaled IL4Ra asthma
AZD2373
Podocyte health nephropathy
AZD2693
nonalcoholic steatohepatitis
AZD3366
CD39L3 CV disease
AZD3427
Relaxin ThP CV disease
AZD4041#
orexin 1 receptor antagonist opioid use disorder
AZD9977
MCR cardiovascular
MEDI0618#
PAR2 antagonist mAb osteooarthritis pain
MEDI1341#
alpha synuclein parkinson's disease
MEDI1814#
amyloidβ alzheimer's disease
MEDI8367
avb8 chronic kidney disease
AZD7442
long-acting antibody combination COVID-19
brazikumab¶
IL23 crohns disease
nirsevimab#
RSV mAb-YTE passive RSV immunisation
PT027#
ICS/SABA asthma
tezepelumab# NAVIGATOR TSLP severe uncontrolled asthma
Under Review
1 New Molecular Entity
anifrolumab# TULIP Type I IFN receptor SLE
anifrolumab#
Type I IFN receptor lupus nephritis
anifrolumab#
Type I IFN receptor SLE SC
AZD4831
MPO HFpEF
AZD5718
FLAP coronary artery disease / CKD
AZD7986#
DPP1 COPD
AZD8233
hypercholesterolemia cardiovascular
AZD8601#
VEGF-A cardiovascular
AZD9567
SGRM chronic inflammatory diseases
brazikumab
IL23 ulcerative colitis
cotadutide
GLP-1/glucagon T2D / obesity / NASH /
DKD
MEDI3506
IL33 diabetic kidney disease
MEDI3506
IL33 AD / COPD / asthma / COVID-19
MEDI5884#
cholesterol modulation cardiovascular
MEDI6570
LOX-1 CV disease
MEDI7352
NGF/TNF OA pain / painful diabetic neuropathy
navafenterol#
MABA COPD
suvratoxumab
α-Toxin Staphylococcus pneumonia
tezepelumab#
TSLP atopic dermatitis
tezepelumab# COURSE TSLP COPD
verinurad
URAT-1 CKD / HFpEF
Phase progressions based on first patient dose achievement. | |||
4 | 1 Includes novel combinations and additional indications for assets where the lead is not yet launched | BioPharmaceuticals | Precision medicine approach being explored |
# Partnered and/or in collaboration; ¶ Registrational Phase II/III trial |
Q1 2021 lifecycle management (LCM)1 pipeline
Phase I | Phase II | Phase III | Under Review | |||
2 Projects | 9 Projects | 30 Projects | 0 Projects | |||
Enhertu# (platform) DESTINY- | Enhertu# (platform) DESTINY- | |
Breast08 | Breast07 | |
ADC breast | ADC breast | |
Imfinzi#+azacitidine# | Enhertu# DESTINY-CRC-01 | |
PD-L1+azacitidine MDS | ADC colorectal cancer | |
Enhertu# DESTINY-Gastric02
ADC gastric
Enhertu# DESTINY-Lung01
ADC NSCLC
Enhertu# DESTINY-PanTumor01 HER2 targeting ADC HER2-expressing solid tumours
Enhertu# DESTINY-PanTumor02 HER2 targeting ADC HER2-expressing solid tumours
Imfinzi# (platform) BEGONIA
PD-L1 1L mTNBC
Imfinzi# (platform) MAGELLAN
PD-L1 1L mNSCLC
Lynparza# (basket) MK-7339-002 /
LYNK002
PARP HRRm cancer
Calquence#
BTK inhibitor 1st line MCL
Calquence#
BTK inhibitor r/r CLL, high risk
Calquence#+venetoclax+ obinutuzumab BTK+BCL-2+anti-CD20 1st line CLL
Calquence+R-CHOP ESCALADE BTK+R-CHOP 1L DLBCL
Enhertu# DESTINY-Breast02
ADC breast
Enhertu# DESTINY-Breast03
ADC breast
Enhertu# DESTINY-Breast04
ADC breast
Enhertu# DESTINY-Breast05
ADC breast
Enhertu# DESTINY-Breast06
ADC breast
Imfinzi# + FLOT MATTERHORN PD-L1+CTxneo-adjuvant/adjuvant gastic cancer
Imfinzi# CALLA
PD-L1 adj. locally-advanced cervical cancer
Imfinzi# PEARL
PD-L1 1L metastatic NSCLC
Imfinzi# post-SBRTPACIFIC-4PD-L1post-SBRT stage I/II NSCLC
Imfinzi# POTOMAC
PD-L1 non muscle invasive bladder cancer
Imfinzi#+CRT KUNLUN PD-L1+CRTlocally-advanced esophageal squamous cell carcinoma
Imfinzi#+CRT PACIFIC-2
PD-L1+CRT NSCLC
Imfinzi#+CRT PACIFIC-5 (China) PD-L1+CRTlocally-advanced stage III NSCLC
Imfinzi#+Ctx MERMAID-1PD-L1 stage II-III adjuvant NSCLC
Imfinzi#+CTx neoadjuvant AEGEAN PD-L1+CTxlocally-advanced stage II-
III NSCLC
Imfinzi#+CTx NIAGARA PD-L1+CTx muscle invasive bladder cancer
Imfinzi#+CTx TOPAZ-1PD-L1+CTx 1L biliary tract cancer
Imfinzi#+VEGF EMERALD-2
PD-L1+VEGF adjuvant HCC
Imfinzi#+VEGF+TACE EMERALD-1PD-L1+VEGF+TACE locoregional
HCC
Lynparza# LYNK-003
PARP platinum sensitive 1L colorectal cancer
Lynparza# OlympiA
PARP gBRCA adjuvant breast
Lynparza# SOLO-3
PARP BRCAm PSR ovarian
Lynparza+abiraterone# PROpel PARP+NHA prostate cancer
Tagrisso +/- CTx neoadjuvant NeoADAURA
EGFR stage II/III resectable EGFRm
Tagrisso LAURA
EGFRm locally-advanced unresectable
NSCLC
Tagrisso+chemo FLAURA2 EGFR+chemo 1L adv EGFRm NSCLC
Phase progressions based on first patient dose achievement. | |
5 | 1 Includes significant LCM projects and parallel indications for assets beyond Phase III |
# Partnered and/or in collaboration; ¶ Registrational Phase II/III trial |
Oncology
Precision medicine approach being explored
Attachments
- Original document
- Permalink
Disclaimer
AstraZeneca plc published this content on 30 April 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 30 April 2021 10:35:07 UTC.