Enhertu recommended for blessing in the EU by CHMP for cases with preliminarily treated HER2-positive advanced gastric cancer
Grounded on fortune- Gastric02 which showed AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated clinically meaningful efficacity and fortune- Gastric01 which showed bettered overall survival compared to chemotherapy
AstraZeneca and Daiichi Sankyo’s Enhertu( trastuzumab deruxtecan) has been recommended for blessing in the European Union( EU) as monotherapy for the treatment of adult cases with advanced HER2-positive gastric or gastroesophageal junction( GEJ) adenocarcinoma who have entered a previous trastuzumab- grounded authority.
Enhertu is a specifically finagled HER2- directed antibody medicine conjugate( ADC) being concertedly advanced and commercialised by AstraZeneca and Daiichi Sankyo.
The Committee for Medicinal Products for Human Use( CHMP) of the European Medicines Agency grounded its positive opinion on results from the fortune- Gastric02 and the fortune- Gastric01 Phase II trials.
In fortune- Gastric02, conducted in cases from North America and Europe, streamlined results showed treatment with Enhertu redounded in a verified objective response rate( ORR) of41.8 as assessed by independent central review( ICR). Median duration of response( DoR) was8.1 months and median overall survival( zilches) was12.1 months. Primary results from the fortune- Gastric02 Phase II trial were presented at the 2021 European Society for Medical Oncology( ESMO) Congress, with the streamlined data presented at ESMO2022.1
In fortune- Gastric01, conducted in cases from Japan and South Korea, streamlined results showed treatment with Enhertu redounded in an ORR of51.3 versus14.3 with chemotherapy( irinotecan or paclitaxel). Cases treated with Enhertu had a 40 reduction in the threat of death versus cases treated with chemotherapy( grounded on a hazard rate of0.60; 95 confidence interval0.42-0.86, p = 0.01) with a median zilches of12.5 months versus8.9 months. also, verified ORR, a major efficacity outgrowth, was42.0 with Enhertu versus12.5 with chemotherapy as assessed by ICR. The primary analysis was published in The New England Journal of Medicine, 2 with the streamlined data presented at the 2021 American Society of Clinical Oncology Annual Meeting.
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said “ Gastric cancer is generally diagnosed in the advanced stage in numerous European countries and cases face high mortalityrates.However, Enhertu would be the first HER2- directed drug for cases with advanced gastric cancer in the European Union in further than a decade, If approved. ”
Ken Takeshita, Global Head, Oncology R&D, Daiichi Sankyo, Inc, said “ Enhertu is the first HER2- directed drug to demonstrate a significant enhancement in overall survival compared to chemotherapy in cases with gastric cancer following original treatment with a HER2- directed drug in the advanced or metastatic setting. The CHMP opinion recognises the high unmet need in this patient population and brings us one step closer to bringing this drug to cases with gastric cancer in Europe. ”
In both trials, the safety biographies observed in cases treated with Enhertu were harmonious with those seen in other trials of Enhertu with no new safety signals linked.
Enhertu is approved in the US and several other countries for locally advanced or metastatic HER2-positive gastric cancer.
AstraZeneca( LSE/ STO/ Nasdaq AZN) is a global, wisdom- led biopharmaceutical company that focuses on the discovery, development, and commercialisation of tradition drugs in Oncology, Rare conditions, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Grounded in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative drugs are used by millions of cases worldwide.