(IN BRIEF) The FDA has accepted AstraZeneca’s sBLA for Imfinzi as a perioperative immunotherapy regimen in resectable early‑stage and locally advanced gastric and GEJ cancers, granting Priority Review with a decision expected in Q4 2025. The application leverages MATTERHORN Phase III data … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged 2025 decision, adjuvant, AstraZeneca, breakthrough therapy designation, clinical paradigm shift, durvalumab, early-stage, EFS hazard ratio, event-free survival, FDA priority review, FLOT chemotherapy, gastric cancer, gastroesophageal junction cancer, high unmet need, Imfinzi, Levi Garraway, locally advanced, MATTERHORN Phase III, neoadjuvant, overall survival, Perioperative Immunotherapy, resectable, sBLA, Susan Galbraith
(IN BRIEF) The MATTERHORN Phase III trial has demonstrated that a perioperative regimen combining AstraZeneca’s Imfinzi (durvalumab) with FLOT chemotherapy significantly improves event-free survival in patients with resectable gastric and gastroesophageal junction cancers compared to standard chemotherapy alone. Interim findings … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged adjuvant, AstraZeneca, clinical trial, Cristian Massacesi, durvalumab, early-stage, EFS, event-free survival, FLOT chemotherapy, gastric cancer, gastroesophageal junction, GEJ cancers, global, Imfinzi, immunotherapy, locally advanced, MATTERHORN, Memorial Sloan Kettering, neoadjuvant, OS, overall survival, pathologic complete response, PCR, Phase III Trial, randomized, resectable, safety profile, tumor regression, Yelena Y. Janjigian
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