European Commission Approves AstraZeneca’s Imfinzi Combo For Gastric Cancer Following Strong Phase III Results

AstraZeneca announced that the European Commission has approved Imfinzi (durvalumab) in combination with FLOT chemotherapy for the treatment of adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. The perioperative regimen includes Imfinzi alongside chemotherapy, both before and after surgery, followed by Imfinzi as a standalone therapy.

The approval follows a positive recommendation from the Committee for Medicinal Products for Human Use and is supported by results from the Phase III MATTERHORN trial, which were published in The New England Journal of Medicine. Gastric cancer remains a major global health burden, ranking among the leading causes of cancer-related deaths, with close to one million new cases diagnosed annually.

Josep Tabernero, MD, PhD, head of the Medical Oncology Department at Vall d'Hebron University Hospital and director of the Vall d’Hebron Institute of Oncology (VHIO) in  Barcelona, Spain, and principal investigator in the trial, said: “Despite curative-intent surgery and chemotherapy, patients with resectable gastric and gastroesophageal cancers still face high recurrence rates and an urgent need for improved long-term survival. In MATTERHORN, nearly 70 per cent of patients were still alive three years after treatment with the durvalumab-based perioperative regimen. This EU approval brings patients the first immunotherapy regimen to extend survival in this early setting and is poised to become the new standard of care.”

Clinical data from a planned interim analysis showed that patients receiving the Imfinzi-based regimen experienced a 29% reduction in the risk of disease progression, recurrence, or death compared to chemotherapy alone. Event-free survival (EFS) rates were higher in the Imfinzi arm at both 12 and 24 months, demonstrating sustained benefit over time.

Final overall survival (OS) results further reinforced the therapy’s impact, showing a 22% reduction in the risk of death versus standard chemotherapy. At three years, approximately 69% of patients in the Imfinzi group were alive, compared to 62% in the chemotherapy-only group. Notably, survival benefits were observed regardless of tumour PD-L1 status, and the treatment effect appeared to increase over time.

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “This approval marks our third perioperative approval in Europe for an Imfinzi-based regimen, underscoring AstraZeneca’s commitment to transforming outcomes in early-stage disease, where cure is possible. For patients with early gastric and gastroesophageal cancers, this immunotherapy-based regimen delivers a durable survival benefit that increases over time.”

The safety profile of the Imfinzi and FLOT combination was consistent with the known safety profiles of both therapies, with similar rates of serious adverse events and surgical completion between treatment groups. The regimen is already approved in the United States and other regions, with additional regulatory reviews ongoing in Japan and several other countries.