Imfinzi (durvalumab), in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel), has received EU approval.
The perioperative immunotherapy was approved to treat adult patients with resectable, early-stage and locally advanced gastric and gastro-oesophageal junction (GEJ) cancers.
Nearly one million people are diagnosed with gastric cancer each year, the fifth leading cause of cancer deaths globally. Rates of early-stage and locally advanced gastric or GEJ cancer in the EU showed around 15,500 patients being treated in 2024.
The European Commission (EC) approval is based on positive results from the MATTERHORN phase 3 trial, the results of which have been published in The New England Journal of Medicine.
The EC approval follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).
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, said: “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.”
In an interim analysis, patients who received the Imfinzi-based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence or death versus with chemotherapy alone.
After a year, around 78.2% of patients treated were event-free, compared to 74.0% in the comparator arm. After two years, the results showed around 67.4% of patients treated were event-free, compared to 58.5% in the comparator arm.
Overall survival (OS) rates showed an improvement of 22% compared to chemotherapy alone, with around 69% of patients surviving for three years compared to 62% in the comparator arm.
Overall survival results from MATTERHORN were presented at the European Society for Medical Oncology (ESMO) Congress 2025.
Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “For patients with early gastric and gastroesophageal cancers, this immunotherapy-based regimen delivers a durable survival benefit that increases over time.”
Based on the MATTERHORN results, Imfinzi and FLOT chemotherapy is approved in the US and other countries, while there are regulatory applications under review for this treatment regime in several other countries, including Japan.