By VETTAPHARMA reporter: EU Brussels, Belgium — 2 February 2026 The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending expanded approval of AstraZeneca’s Imfinzi (durvalumab) as a perioperative therapy for adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers (AstraZeneca, 2026). If formally authorized by the European Commission, this would be the first immunotherapy-based perioperative regimen available for these indications in the European Union (EU).
The recommendation is grounded in previously presented MATTERHORN Phase III clinical trial data, showing that the Imfinzi-based perioperative regimen — combining Imfinzi with standard FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) before and after surgery — resulted in a 29% reduction in the risk of progression, recurrence or death compared to chemotherapy alone (AstraZeneca, 2026). In intermediate analyses, 78.2% of patients treated with the regimen remained event-free at one year, compared with 74.0% in the comparator group, while estimated event-free survival at 24 months was 67.4% vs. 58.5%, respectively.
Safety outcomes were consistent with known profiles, with similar rates of Grade 3 or higher adverse events in both treatment arms (AstraZeneca, 2026). Updated results presented at major oncology conferences also demonstrated a 22% reduction in the risk of death, reinforcing potential long-term benefit.
Experts involved in the MATTERHORN trial noted that many patients with early gastric and GEJ cancers face high rates of recurrence and poor long-term outcomes despite conventional curative-intent surgery and chemotherapy — highlighting the clinical importance of this new immunotherapy approach.
A final decision on the marketing authorization variation will be made by the European Commission, following the CHMP’s positive opinion. Should approval be granted, Imfinzi could significantly impact treatment paradigms for resectable gastric cancers across the EU.
Source credit:
- AstraZeneca. (2026, February 2). Imfinzi perioperative regimen recommended for approval in the EU by CHMP for patients with early gastric and gastroesophageal cancers. AstraZeneca. Click here
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