ASTRAZENECA PLC Clinical trials appendix
Q3 2022 results update
Pipeline catalysts for 2022 - 2023
Oncology BioPharmaceuticals Rare Disease | ||
H2 2022 | H1 2023 | H2 2023 |
Imfinzi - biliary tract cancer (TOPAZ-1) (JP)
Imfinzi - liver cancer (1L) (HIMALAYA) (JP)
Imfinzi - NSCLC (1L) (POSEIDON)
Lynparza - prostate cancer (1L) (PROpel)
Enhertu - HER2+ breast cancer (2L) (DESTINY-Breast03) (JP)
Calquence - CLL (ELEVATE-TN) (JP)
Regulatory decision
Imfinzi - biliary tract cancer (TOPAZ-1) (EU) | Soliris - gMG (CN) |
Imfinzi - liver cancer (1L) (HIMALAYA) (EU) | Koselugo - NF1-PN (SPRINT) (CN) |
Lynparza - breast cancer (OlympiAD) (CN) | |
Enhertu - HER2-low breast cancer (3L) (DESTINY-Breast04) (EU) | |
Enhertu - HER2+ gastric cancer (2L) (DESTINY-Gastric01) (EU) | |
Enhertu - HER2+ breast cancer (2L) (DESTINY-Breast03) (CN) | |
Enhertu - HER2-low breast cancer (3L) (DESTINY-Breast04) (JP, CN) | |
Farxiga - HFpEF (DELIVER) | |
PT027 - asthma (MANDALA/DENALI) (US) | |
Ultomiris - NMOSD (CHAMPION-NMOSD) |
Calquence - CLL (ASCEND) CN) | Imfinzi - liver cancer (locoregional) (EMERALD-1) | Tagrisso - EGFRm NSCLC (1L) (FLAURA2) | |
eplontersen - ATTRv-PN(NEURO-TTRansform) (US) | Imfinzi - liver cancer (adjuvant) (EMERALD-2) | Tagrisso - EGFRm NSCLC (unresectable Stg. III) (LAURA) | |
Regulatory | Beyfortus - RSV (MELODY/MEDLEY) (US) | Imfinzi - NSCLC (1L) (PEARL) | Imfinzi - biliary tract cancer (TOPAZ-1) (CN) |
Evusheld - COVID-19 (TACKLE/PROVENT) (CN) | Lynparza - gBRCA breast cancer (adjuvant) (OlympiA) (CN) | Imfinzi - NSCLC (unresectable, Stg. III) (PACIFIC-2) | |
submission | capivasertib - HR+/HER2-neg breast cancer (1L) (CAPItello-291) | Imfinzi - bladder cancer (muscle invasive) (NIAGARA) | |
and/or | Dato-DXd - NSCLC (3L) (TROPION-Lung01) | Imfinzi - bladder cancer (1L) (NILE) | |
acceptance | Beyfortus - RSV (MELODY/MEDLEY) (JP, CN) | Imfinzi - NSCLC (neoadjuvant) (AEGEAN) | |
danicopan - PNH with extravascular haemolysis | Imfinzi - SCLC (limited-stage) (ADRIATIC) | ||
capivasertib - TNBC (locally adv./met.) (CAPItello-290) | |||
Key Phase III data readouts
Imfinzi - liver cancer (locoregional) (EMERALD-1) | Tagrisso - EGFRm NSCLC (1L) (FLAURA2) | Tagrisso - EGFRm NSCLC (unresectable Stg. III) (LAURA) |
Imfinzi - NSCLC (1L) (PEARL) | Imfinzi - SCLC (limited-stage)(ADRIATIC) | Imfinzi - NSCLC (unresectable, Stg. III) (PACIFIC-2) |
Imfinzi - NSCLC (neoadjuvant) (AEGEAN) | Imfinzi - bladder cancer (muscle invasive) (NIAGARA) | |
Imfinzi - liver cancer (adjuvant) (EMERALD-2) | Imfinzi - bladder cancer (1L) (NILE) | |
Lynparza - ovarian cancer (1L) (DUO-O) | Lynparza - endometrial cancer (1L) (DUO-E) | |
Dato-DXd - NSCLC (3L) (TROPION-Lung01) | Enhertu - HER2-low breast cancer (2L) (DESTINY-Breast06) | |
roxadustat - anaemia of myelodysplastic syndrome | Calquence - MCL (1L) (ECHO) | |
capivasertib - TNBC (locally adv./met.) (CAPItello-290) | ||
Farxiga - myocardial infarction (DAPA-MI) | ||
Fasenra - EGPA (MANDARA) | ||
Fasenra - HES (NATRON) |
1L = 1st-line; 2L = 2nd-line; 3L = 3rd-line; NSCLC = non-small cell lung cancer; HER2+ = human epidermal growth factor receptor 2-positive;HER2-low = human epidermal growth factor receptor 2-low; CLL = chronic lymphocytic leukaemia; HFpEF = heart failure with preserved ejection faction; RSV = respiratory syncytial virus; CKD = chronic kidney disease; ATTRv-PN = hereditary transthyretin-mediated amyloid polyneuropathy; NMOSD = neuromyelitis optica spectrum disorder; gBRCAm = germline BRCA mutated; HR+
-
hormone receptor-positive;HER2-neg = human epidermal growth factor receptor 2 negative; Dato-DXd = datopotamab deruxtecan; EoE = eosinophilic oesophagitis; PNH = paroxysmal nocturnal haemoglobinuria; gMG = generalised myasthenia gravis; NF1= 2 neurofibromatosis type 1; PN = plexiform neurofibromas; EGFRm = epidermal growth factor receptor mutated; SCLC = small cell lung cancer; TNBC = triple negative breast cancer; MCL = mantle cell lymphoma; EGPA = eosinophilic granulomatosis with
polyangiitis; HES = hyper eosinophilic syndrome.
CTA selected highlights
BioPharmaceuticals | Oncology | Rare Disease |
Key LCM
Approved medicines:
Pipeline: Next wave
Dato-DXd (TROP2 ADC) | ||||
tozorakimab (IL-33) | ||||
volrustomig (PD1-CTLA4) | ||||
ngCOVID-19 LAAB | ||||
vemircopan (oral Factor D) | ||||
capivasertib (AKT) | ||||
eplontersen (LICA) | gefurulimab (C5 mini-body) | |||
camizestrant (ngSERD) | ||||
mitiperstat (MPO) | ALXN1850 (ngHPP) | |||
AZD2936 (PD1-TIGIT) | ||||
cotadutide (GLP-1/Glucagon)
AZD5305 (PARP-1sel)
3
Movement since Q2 2022 update
New to Phase I | New to Phase II | New to Pivotal trial | New to registration |
NME | NME | Life-cycle management | Life-cycle management |
ALXN2030 | AZD8205 | Tagrisso + Orpathys SAFFRON# | Farxiga/Forxiga DELIVER1 |
siRNA targeting complement C3 | B7-H4 targeting antibody drug conjugate solid | EGFR inhibitor + MET inhibitor advanced EGFRm non- | SGLT-2 inhibitor worsening HF or CV death in patients with |
nephrology | tumours | small cell lung cancer | chronic heart failure (HFpEF) |
ALXN2080# | Additional indication | Ultomiris CHAMPION-NMOSD1 | |
oral factor D inhibitor healthy volunteers | vemircopan (ALXN2050) | anti-complement C5 mAb neuromyelitis optica spectrum | |
AZD6234 | oral Factor D inhibitor proliferative lupus | disorder | |
nephritis or immunoglobulin A nephropathy | |||
long-acting amylin obesity with related | |||
comorbidities | |||
AZD7798 | |||
humanised monoclonal antibody targets T | |||
cells subset Crohn's disease | |||
AZD9574 | |||
PARP inhibitor advanced solid malignancies | |||
4 | Phase progressions based on first patient dose achievement. |
1 Submission accepted 2 Approved # Partnered and/or in collaboration ¶ Registrational Phase II/III trial |
Movement since Q2 2022 update
Removed from Phase I | Removed from Phase II | Removed from Phase III | Removed from registration |
NME | NME | Additional indication | NME |
AZD5991 | AZD8233 | monalizumab + cetuximab INTERLINK-1# | Beyfortus (nirsevimab)#2 |
MCL1 inhibitor haematological | PCSK9-ASO hypercholesterolemia | NKG2A mAb + EGFR mAb 2L+ relapsed metastatic head | RSV mAb-YTE passive RSV immunisation |
malignancies | Additional indications | and neck squamous cell cancer | Imfinzi + Imjudo (tremelimumab) HIMALAYA#2 |
MEDI1191# | |||
atuliflapon (AZD5718) | Life-cycle management | PD-L1 mAb + CTLA-4 mAb 1st-line hepatocellular carcinoma | |
IL12 mRNA solid tumours | FLAP coronary artery disease / chronic kidney | Fasenra MAHALE | Life-cycle management |
MEDI8367 | disease | IL-5R mAb non-cystic fibrosis bronchiectasis | |
cotadutide | Fasenra MESSINA | Enhertu DESTINY-Lung01#2 | |
Avb8 chronic kidney disease | HER2 targeting antibody drug conjugate HER2-over- | ||
GLP-1/glucagon dual agonist type-2 diabetes, | IL-5R mAb eosinophilic esophagitis | expressing or -mutated, unresectable and/or metastatic non- | |
obesity and diabetic kidney disease | Imfinzi + CTx MERMAID-1 | small cell lung cancer | |
PD-L1 mAb + CTx stage II-III adjuvant non-small cell lung | Enhertu DESTINY-Breast04#2 | ||
cancer | HER2 targeting antibody drug conjugate HER2-low, | ||
Imfinzi MERMAID-2 | unresectable and/or metastatic breast cancer subjects | ||
PD-L1 mAb stage II-III premetastatic non-small cell lung | Evusheld TACKLE2 | ||
cancer | LAAB combination treatment of COVID-19 | ||
Ultomiris | Imfinzi + CTx TOPAZ-1#2 | ||
anti-complement C5 mAb complement-mediated | PD-L1 mAb + CTx 1st-line biliary tract cancer | ||
thrombotic microangiopathy | Ultomiris2 | ||
anti-complement C5 mAb subcutaneous, paroxysmal | |||
nocturnal haemoglobinuria and atypical haemolytic uraemic | |||
syndrome | |||
5 | Phase progressions based on first patient dose achievement. |
1 Submission accepted 2 Approved # Partnered and/or in collaboration ¶ Registrational Phase II/III trial |
This is an excerpt of the original content. To continue reading it, access the original document here.
Attachments
- Original Link
- Original Document
- Permalink
Disclaimer
AstraZeneca plc published this content on 10 November 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 November 2022 07:16:08 UTC.
