AI Analysis
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AstraZeneca's Imfinzi (durvalumab) in combination with FLOT chemotherapy has been approved in the EU for perioperative treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction cancers. The approval, based on MATTERHORN Phase III trial results, demonstrated 29% reduction in event-free survival risk and 22% reduction in overall survival risk versus chemotherapy alone.
Key Takeaways
1Imfinzi + FLOT approved in EU on 16 March 2026 as first perioperative immunotherapy for Stages II, III, IVA resectable gastric and GEJ cancers
2MATTERHORN Phase III: EFS HR 0.71 (95% CI 0.58-0.86; p<0.001); median EFS not reached vs 32.8 months
3MATTERHORN OS: HR 0.78 (95% CI 0.63-0.96; p=0.021); 3-year OS 69% vs 62%
4Regimen: 2 cycles Imfinzi + FLOT pre/post-surgery, then Imfinzi monotherapy up to 12 cycles
5Safety: Grade 3+ AEs 71.6% (Imfinzi arm) vs 71.2% (chemotherapy); similar surgery completion rates
6Approval follows positive CHMP opinion; already approved in US and others, under review in Japan