CHMP has recommended EU approval of AstraZeneca’s Imfinzi (durvalumab) plus FLOT chemotherapy as perioperative treatment for resectable gastric and gastroesophageal junction cancers, based on Phase III MATTERHORN trial survival benefits.
Written By: Pharmacally Medical News Desk
AstraZeneca’s Imfinzi (durvalumab), combined with standard FLOT chemotherapy, has won a positive opinion from the European Medicines Agency’s CHMP for EU approval. This targets adults with resectable Stages II, III and IVA gastric and gastroesophageal junction (GEJ) cancers tumors that can be surgically removed but carry high recurrence risk. The proposed regimen uses Imfinzi plus chemo before surgery (neoadjuvant), continues it after (adjuvant), and shifts to Imfinzi alone post-op, potentially setting a new immunotherapy benchmark if approved.
Susan Galbraith, Executive Vice President of Oncology Haematology R&D at AstraZeneca, highlighted the durable long-term benefit of Imfinzi plus FLOT, with over two-thirds of patients alive at three years, calling the recommendation an important step toward expanding curative options in early-stage cancers across the EU.
MATTERHORN Trial Fuels the Buzz
The decision was based on The Phase III MATTERHORN trial (NCT04592913) a large, randomized study showed Imfinzi + FLOT slashing event-free survival (EFS) risk by 29% versus chemo alone (HR 0.71). Median EFS wasn’t reached in the Imfinzi group, compared to 32.8 months for chemo; at 2 years, 67% stayed event-free versus 59%. These results, unveiled at the 2025 ASCO meeting and published in The New England Journal of Medicine, highlight how adding immunotherapy curbs progression, recurrence, or death.
Survival Gains Hold Strong
Overall survival (OS) the ultimate measure of lives saved followed with a 22% lower risk of death (hazard ratio 0.78), At 3 years, 69% remained alive versus 62%. Crucially, gains held across PD-L1 levels broadening access. Presented at ESMO 2025, this proves durable impact in high-risk gastric/GEJ cases.
Safety aligned with known profiles (Grade 3+ events ~72% both arms), with equal surgery success. Gastric cancer, a top global killer (~1M cases/year), sees 1-in-4 recurrences in year 1 and <50% 5-year survival making this vital.
Josep Tabernero, MD, PhD, principal investigator of the MATTERHORN trial, said the CHMP recommendation represents a major advance for EU patients with early gastric and GEJ cancers, marking the first perioperative immunotherapy regimen to significantly improve survival and potentially set a new standard of care.
US approvals are in place; Japan and others pending. Imfinzi has reached 414K+ patients worldwide since 2017.
About Imfinzi
Imfinzi (durvalumab) is a PD-L1–targeting monoclonal antibody that helps the immune system recognize and attack cancer cells by blocking tumour immune evasion. It is approved across multiple cancers, including biliary tract cancer and hepatocellular carcinoma in gastrointestinal oncology. Imfinzi is also a global standard of care in several lung cancer settings, as well as in muscle-invasive bladder cancer and certain endometrial cancers. Since its first approval in 2017, more than 414,000 patients have been treated, and the drug continues to be evaluated in a broad range of tumour types and combination strategies. The U.S. Food and Drug Administration (FDA) has already approved Imfinzi (durvalumab) for this indication based on the positive results from the Phase III MATTERHORN trial.
References
Imfinzi perioperative regimen recommended for approval in the EU by CHMP for patients with early gastric and gastroesophageal cancers, 02 February 2026, Imfinzi perioperative regimen recommended for approval in the EU by CHMP for patients with early gastric and gastroesophageal cancers
Yelena Y. Janjigian et al, Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer, N Engl J Med 2025;393:217-230, Perioperative Durvalumab in Gastric and Gastroesophageal Junction Cancer | New England Journal of Medicine
Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer, ClinicalTrials.gov ID NCT04592913, Study Details | NCT04592913 | Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer | ClinicalTrials.gov