Spaces:
Runtime error
Runtime error
stock_news_summaries_AI
/
news
/AZN
/2023.02.09
/Astrazeneca : Full Year and Q4 2022 results clinical trials appendix.txt
| Clinical Trials Appendix | |
| Q4 2022 Results Update | |
| Upcoming pipeline catalysts: 2023 and 2024 | |
| Oncology BioPharmaceuticals Rare Disease | |
| H1 2023 | |
| H2 2023 | |
| 2024 | |
| Regulatory decision | |
| Imfinzi + Imjudo - hepatocellular carcinoma (1L) (HIMALAYA) (EU) Imfinzi +/- Imjudo - NSCLC (1L) (POSEIDON) (EU) | |
| Lynparza - prostate cancer (1L) (PROpel) (US, JP) | |
| Enhertu - HER2+ breast cancer (2L) (DESTINY-Breast03) (CN) Enhertu - HER2-low breast cancer (3L) (DESTINY-Breast04) (JP) Farxiga - HFpEF (DELIVER) (US) | |
| Beyfortus - respiratory syncytial virus (US) Ultomiris - NMOSD (CHAMPION-NMOSD) | |
| Enhertu - HER2m NSCLC (2L+) (DESTINY-Lung01) (EU, JP) Enhertu - HER2-low breast cancer (3L) (DESTINY-Breast04) (CN) Calquence - CLL (ASCEND) (CN) | |
| Forxiga - HFpEF (DELIVER) (CN) Soliris - gMG (CN) | |
| Soliris - NMOSD (CN) | |
| Koselugo - NF1-PN (SPRINT) (CN) | |
| Regulatory submission and/or acceptance | |
| Lynparza - gBRCA breast cancer (adjuvant) (OlympiA) (CN) Enhertu - HER2+ breast cancer (3L) (DESTINY-Breast02)capivasertib - HR+/HER2- breast cancer (1L) (CAPItello-291)Dato-DXd - NSCLC (3L) (TROPION-Lung01) | |
| eplontersen - hATTR-PN(NEURO-TTRansform) (US) Beyfortus - respiratory syncytial virus (JP, CN) Evusheld - COVID-19 (TACKLE/PROVENT) (CN) danicopan - PNH with extravascular haemolysis | |
| Tagrisso - EGFRm NSCLC (1L) (FLAURA2) | |
| Tagrisso - EGFRm NSCLC (unresectable Stg. III) (LAURA) Imfinzi - NSCLC (neoadjuvant) (AEGEAN) | |
| Imfinzi - liver cancer (adjuvant) (EMERALD-2)Imfinzi - bladder cancer (muscle invasive) (NIAGARA) Imfinzi - biliary tract cancer (TOPAZ-1) (CN) | |
| Imfinzi - bladder cancer (1L) (NILE) | |
| capivasertib - TNBC (locally adv./met.) (CAPItello-290)AZD3152 - prevention of COVID-19 (SUPERNOVA) ALXN1840 - Wilson disease | |
| Tagrisso - EGFRm NSCLC (resectable, Stg. II/III) (NeoADAURA) | |
| Calquence - MCL (1L) (ECHO) | |
| Imfinzi + Imjudo - hepatocellular carcinoma (1L) (HIMALAYA) (CN) | |
| camizestrant - HR+/HER2-neg breast cancer (SERENA-6) | |
| Imfinzi - NSCLC (unresectable, Stg. III) (PACIFIC-2) | |
| roxadustat - anaemia of myelodysplastic syndrome) | |
| Imfinzi - liver cancer (locoregional) (EMERALD-1) | |
| tozorakimab - acute respiratory failure (TILIA) | |
| Imfinzi - SCLC (limited-stage) (ADRIATIC) | |
| Breztri - severe asthma (KALOS) | |
| Lynparza - ovarian cancer (1L) (DUO-O) | |
| Breztri - severe asthma (LOGOS) | |
| Lynparza - endometrial cancer (1L) (DUO-E) | |
| Fasenra - bullous pemphigoid (FJORD) | |
| Lynparza - prostate cancer (1L) (PROpel) (CN) | |
| Fasenra - EGPA (MANDARA) | |
| Enhertu - HER2+/HER2low gastric 3L (DESTINY-Gastric01) (CN) | |
| Fasenra - HES (NATRON) | |
| Enhertu - HER2+ gastric (2L) (DESTINY-Gastric04) | |
| acoramidis - ATTR-CM(ALXN2060-TAC-302) | |
| Enhertu - HER2-low breast cancer (2L) (DESTINY-Breast06) | |
| anselamimab - AL amyloidosis (CAEL101-302) | |
| Enhertu - High-risk HER2+ early breast cancer (non-met.) | |
| (DESTINY-Breast11) | |
| Key Phase III data readouts | |
| Tagrisso - EGFRm NSCLC (1L) (FLAURA2) | |
| Tagrisso - EGFRm NSCLC (unresectable Stg. III) (LAURA) | |
| Tagrisso - EGFRm NSCLC (resectable, Stg. II/III) (NeoADAURA) | |
| Fasenra - CRwNP (ORCHID) | |
| Imfinzi - NSCLC (neoadjuvant) (AEGEAN) | |
| Imfinzi - NSCLC (unresectable, Stg. III) (PACIFIC-2) | |
| Lynparza - PARP 1L BRCAwt ovarian cancer (MONO-OLA1) | |
| Fasenra - bullous pemphigoid (FJORD) | |
| Lynparza - ovarian cancer (1L) (DUO-O) | |
| Imfinzi - SCLC (limited-stage)(ADRIATIC) | |
| Enhertu - High-risk HER2+ early breast cancer (non-met.) | |
| Saphnelo - moderate to severe SLE (TULIP-SC) | |
| Dato-DXd - NSCLC (3L) (TROPION-Lung01) | |
| Imfinzi - liver cancer (locoregional) (EMERALD-1) | |
| (DESTINY-Breast11) | |
| Tezspire - chronic rhinosinusitis with nasal polyps | |
| roxadustat - anaemia of myelodysplastic syndrome | |
| Imfinzi - liver cancer (adjuvant) (EMERALD-2) | |
| Enhertu - HER2+ gastric (2L) (DESTINY-Gastric04) | |
| (WAYPOINT) | |
| Imfinzi - bladder cancer (muscle invasive) (NIAGARA) | |
| Calquence - MCL (1L) (ECHO) | |
| Tezspire - severe asthma (DIRECTION) | |
| Imfinzi - bladder cancer (1L) (NILE) | |
| Orpathys - NSCLC with MET exon 14 mutations (locally adv./met.) | |
| Ultomiris - HSCT-TMA (ALXN1210-TM-313) | |
| Lynparza - endometrial cancer (1L) (DUO-E) | |
| camizestrant - HR+/HER2- breast cancer (SERENA-6) | |
| Ultomiris - paedeatric HSCT-TMA(ALXN1210-TM-314) | |
| Enhertu - HER2-low breast cancer (2L) (DESTINY-Breast06) | |
| Dato-DXd - TNBC (locally recurrent inop./met.) | |
| Koselugo - NF1-PN (KOMET) | |
| capivasertib - TNBC (locally adv./met.) (CAPItello-290) | |
| (TROPION-Breast02) | |
| acoramidis - ATTR-CM (ALXN2060-TAC-302) | |
| Farxiga - myocardial infarction (DAPA-MI) | |
| tozorakimab - acute respiratory failure (TILIA) | |
| anselamimab - AL amyloidosis (CAEL101-302) | |
| Fasenra - EGPA (MANDARA) | |
| Breztri - severe asthma (KALOS) | |
| Fasenra - HES (NATRON) | |
| Breztri - severe asthma (LOGOS) | |
| AZD3152 - prevention of COVID-19(SUPERNOVA) | |
| 2 | |
| Appendix: Glossary. | |
| Clinical Trials Appendix: selected highlights | |
| Approved medicines: key LCM | |
| Next-wave pipeline | |
| BioPharmaceuticals | |
| Oncology | |
| Rare Disease | |
| Dato-DXd (TROP2 ADC) | |
| tozorakimab (IL-33) | |
| volrustomig (PD-1/CTLA-4) | |
| AZD3152 (COVID-19 LAAB) | |
| vemircopan (oral Factor D) | |
| capivasertib (AKT) | |
| eplontersen (LICA) | |
| gefurulimab (C5 mini-body) | |
| camizestrant (ngSERD) | |
| mitiperstat (MPO) | |
| ALXN1850 (ngHPP) | |
| rilvegostomig (PD-1/TIGIT) | |
| cotadutide (GLP-1/glucagon) | |
| AZD5305 (PARP-1sel) | |
| 3 | |
| Appendix: Glossary. | |
| Movements since Q3 2022 update | |
| New to Phase I | |
| New to Phase II | |
| New to Pivotal trial | |
| New to registration | |
| NME | |
| NME | |
| NME | |
| AZD0186# | |
| MEDI1341# | |
| AZD3152ยถ | |
| GLP-1R agonism type-2 diabetes | |
| alpha synuclein mAb multiple system | |
| SARS-CoV-2 LAAB prevention of COVID-19 | |
| atrophy/Parkinson's disease | |
| AZD6793 | |
| ceralasertib + Imfinzi LATIFY# | |
| IRAK4 inhibitor inflammatory diseases | |
| rilvegostomig (AZD2936) ARTEMIDE-1# | |
| ATR inhibitor + PDL-1 mAb non-small cell lung | |
| PD-1/TIGIT bispecific mAb solid tumours | |
| cancer | |
| AZD9592 | |
| EGFR/cMET solid tumours | |
| Additional indication | |
| gefurulimab | |
| mitiperstat# | |
| humanised bispecific VHH antibody generalised | |
| myeloperoxidase COPD | |
| myasthenia gravis | |
| mitiperstat# | |
| Additional indication | |
| myeloperoxidase NASH | |
| tozorakimab | |
| IL-33 mAb acute respiratory failure | |
| datopotamab deructucan AVANZAR# | |
| TROP2 ADC 1L NSCLC, squamous and non- | |
| squamous 1L NSCLC, TROP2 BM+ | |
| Dato-DXd TROPION Lung07# | |
| TROP2 ADC 1L NSCLC PD-L1 <50% non-squamous | |
| Dato-DXdTROPION-Breast03# | |
| TROP2 ADC adjuvant residual disease triple | |
| negative breast cancer | |
| Phase progressions based on first patient dose achievement. | |
| 4 #Partnered and/or in collaboration ยถRegistrational Phase I/III trial Appendix: Glossary. | |
| Movements since Q3 2022 update | |
| Removed from Phase I | |
| Removed from Phase II | |
| Removed from Phase III | |
| Removed from registration | |
| NME | |
| NME | |
| Life-cycle management | |
| NME | |
| AZD8701 +/- Imfinzi# | |
| navafenterol# | |
| Fasenra HUDSON | |
| Airsupra (PT027)#2 | |
| FOXP3 +/- PD-L1 mAb solid tumours | |
| MABA chronic obstructive pulmonary | |
| IL-5R mAb eosinophilic gastritis and | |
| ICS/SABA asthma | |
| disease | |
| eosinophilic gastroenteritis | |
| MEDI9253 | |
| Life-cycle management | |
| rNDV IL-12 solid tumours | |
| Additional indication | |
| Imfinzi PEARL# | |
| Farxiga/Forxiga DELIVER2 | |
| tozorakimab | |
| PD-L1 mAb 1st-line metastatic non-small cell | |
| SGLT2 inhibitor worsening HF or CV death in | |
| IL-33 mAb atopic dermatitis | |
| lung cancer | |
| patients with chronic heart failure | |
| Life-cycle management | |
| Imfinzi +/- Imjudo + CTx POSEIDON#2 | |
| Fasenra ARROYO | |
| PD-L1 mAb +/- CTLA-4 mAb + CTx 1st-line non- | |
| IL-5R mAb chronic spontaneous urticaria | |
| small cell lung cancer | |
| Lynparza + abiraterone PROpel#2 | |
| PARP inhibitor + NHA prostate cancer | |
| Phase progressions based on first patient dose achievement. | |
| 5 2Approved #Partnered and/or in collaboration Appendix: Glossary. | |
| 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 09 February 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 February 2023 07:12:40 UTC. | |