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Imfinzi approved in US for early gastric cancer
AstraZeneca's Imfinzi, in combination with FLOT chemotherapy, has received US approval as the first and only perioperative immunotherapy for early-stage gastric and gastroesophageal junction cancers, following MATTERHORN trial results showing a 29% reduction in the risk of progression, recurrence, or death and a 22% reduction in the risk of death compared to chemotherapy alone. The approved regimen includes neoadjuvant and adjuvant Imfinzi with chemotherapy, followed by Imfinzi monotherapy, with nearly seven in ten patients alive at three years. This approval marks a new clinical paradigm for these early-stage cancers, with regulatory applications also under review in Australia, Canada, Switzerland, the European Union, and Japan. Disclaimer*
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\n26 November 2025\n \nImfinzi approved in the US as first and only perioperative immunotherapy for patients with early gastric and gastroesophageal cancers\n \n Based on MATTERHORN Phase III trial results which showed a 29% reduction in the risk of progression, recurrence or death and a 22% reduction in the risk of death for the Imfinzi regimen vs. chemotherapy alone\n \nAstraZeneca's Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the US for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The approved regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi monotherapy.\n \nThe approval follows Priority Review by the Food and Drug Administration (FDA) and is based on event-free survival (EFS) and overall survival (OS) data from the MATTERHORN Phase III trial. The EFS results were presented during the Plenary Session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine. OS results from MATTERHORN were presented in a Proffered Paper session at the European Society for Medical Oncology (ESMO) Congress 2025.\n \nGastric cancer is the fifth leading cause of cancer death globally, with nearly one million people diagnosed each year.1 In 2024, there were roughly 6,500 drug-treated patients in the US in early-stage and locally advanced gastric or GEJ cancer.2\n \nDave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: \"This approval ushers in a new clinical paradigm for patients with early gastric and gastroesophageal junction cancers, with Imfinzi plus FLOT delivering a durable survival benefit that increases over time. As the third US approval for a perioperative Imfinzi-based regimen, this milestone further validates the perioperative approach and underscores our focus on bringing novel treatments to early-stage cancers where cure is the goal.\"\n \nYelena Y. Janjigian, MD, Chief Attending Physician of the Gastr...