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Imfinzi recommended in EU for early gastric cancer
AstraZeneca's Imfinzi, in combination with FLOT chemotherapy, has received a positive recommendation from the EU's CHMP for early-stage gastric and gastroesophageal junction cancers. This recommendation is based on the MATTERHORN Phase III trial, which demonstrated a 29% reduction in the risk of disease progression, recurrence, or death and a 22% reduction in the risk of death compared to chemotherapy alone. If approved, this regimen would be the first immunotherapy-based perioperative therapy for this patient group in the EU, offering a significant survival benefit with an estimated 69% of patients alive at three years. Disclaimer*
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[{"type":"text","content":"\n\n02 February 2026\n \nImfinzi perioperative regimen recommended for approval in the EU by\nCHMP for patients with early gastric and gastroesophageal cancers\n \n Recommendation based on MATTERHORN Phase III trial results which showed a 29% reduction in the risk of progression, recurrence or death and a 22% reduction in the risk of death for the Imfinzi regimen vs. chemotherapy alone\n \nIf approved, Imfinzi regimen would be the first immunotherapy-based\nperioperative therapy for patients in this setting in the EU\n \nAstraZeneca's Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been recommended for approval in the European Union (EU) for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, then Imfinzi monotherapy.\n \nThe Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on event-free survival (EFS) and overall survival (OS) data from the MATTERHORN Phase III trial. The EFS results were presented during the Plenary Session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine.\nIn 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 (based on an EFS hazard ratio [HR] of 0.71; 95% confidence interval [CI] 0.58-0.86; p<0.001). Estimated median EFS was not yet reached for the Imfinzi arm versus 32.8 months for the comparator arm. An estimated 78.2% of patients treated with the Imfinzi-based perioperative regimen were event-free at one year, compared to 74.0% in the comparator arm; the estimated 24-month EFS rate was 67.4% versus 58.5%, respectively.\nIn the final OS 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% compared to ...