The European Commission has approved AstraZeneca’s Imfinzi (durvalumab) in combination with FLOT chemotherapy regimen for adults with early-stage gastric and gastroesophageal junction (GEJ) cancers—marking a major step forward for patients facing high recurrence after surgery.
The newly approved perioperative regimen pairs Imfinzi with FLOT chemotherapy—fluorouracil, leucovorin, oxaliplatin and docetaxel—administered in two cycles before surgery and two cycles after surgery, followed by Imfinzi monotherapy.
The decision follows a positive recommendation from the Committee for Medicinal Products for Human Use and is backed by results from the Phase III MATTERHORN trial, published in The New England Journal of Medicine.
Gastric cancer remains the fifth leading cause of cancer-related deaths worldwide, with nearly one million new cases diagnosed every year. In 2024 alone, about 15,500 patients in the European Union received drug treatment for early-stage or locally advanced gastric or GEJ cancer.
“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,” said Josep Tabernero, 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.
AstraZeneca says the approval strengthens its push to bring immunotherapy earlier into cancer treatment, where long-term cures are possible.
“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,” said Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca.
Trial results underline the survival advantage. In a planned interim analysis, patients receiving the Imfinzi-based perioperative regimen experienced a 29% reduction in the risk of disease progression, recurrence or death compared with chemotherapy alone. Median event-free survival had not yet been reached in the Imfinzi arm, while it stood at 32.8 months in the comparator group.
At one year, 78.2% of patients treated with the Imfinzi regimen remained event-free, compared with 74.0% of those receiving chemotherapy alone. By two years, event-free survival rates were 67.4% versus 58.5%, respectively.
Final overall survival results also showed a significant benefit. The Imfinzi and FLOT combination reduced the risk of death by 22% compared with chemotherapy alone. About 69% of patients receiving the immunotherapy-based regimen were alive three years after treatment, compared with 62% in the chemotherapy-only arm.
