- AstraZeneca
- 16 March 2026 08:20:03
Source: Sharecast
AstraZeneca said the approval by the European Commission followed a positive opinion from the Committee for Medicinal Products for Human Use and was based on the results from its MATTERHORN Phase III trial.
Imfinzi received approval for use in combination with standard-of-care FLOT chemotherapy, with the regimen including two cycles of Imfinzi in combination with chemotherapy before and after surgery, followed by Imfinzi monotherapy.
In a planned interim analysis, patients treated with the Imfinzi-based perioperative regimen showed a 29% reduction in the risk of disease progression, recurrence or death versus chemotherapy alone. In a final overall survival analysis, results showed the Imfinzi and FLOT perioperative regimen demonstrated "a statistically significant and clinically meaningful" survival improvement, reducing the risk of death by 22%.
Dave Fredrickson, executive vice president of AstraZeneca's oncology haematology business unit, 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."
As of 0820 GMT, AstraZeneca shares were down 0.14% at 14,378p.
Reporting by Iain Gilbert at Sharecast.com