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.