FDA Approves Imfinzi for Early Gastric and Gastroesophageal Cancers

WEDNESDAY, Dec. 3, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Imfinzi (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) for treating adult patients with resectable, early-stage, and locally advanced (stages II, III, IVA) gastric and gastroesophageal junction cancers.The priority review approval marks the first and only for perioperative immunotherapy for patients with early gastric and gastroesophageal cancers. The regimen includes neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy and then Imfinzi monotherapy.The approval is based on findings from the phase 3 MATTERHORN trial, which showed that patients treated with the Imfinzi-based perioperative regimen had a lower risk for disease progression, recurrence, or death versus chemotherapy alone (event-free survival [EFS]: hazard ratio, 0.71). In the Imfinzi arm, the estimated median EFS was not yet reached versus 32.8 months for the comparator arm. At one year, an estimated 78.2 percent of patients treated with the Imfinzi-based perioperative regimen were event-free versus 74.0 percent in the comparator arm; the estimated 24-month EFS rate was 67.4 and 58.5 percent, respectively. Similarly, for overall survival, the Imfinzi and FLOT perioperative regimen reduced the risk for death versus chemotherapy alone (hazard ratio, 0.78). At three years, an estimated 69 percent of patients treated with the Imfinzi-based regimen were alive versus 62 percent in the FLOT-only arm. Overall survival curves continued separating with longer follow-up, suggesting a greater benefit over time for the Imfinzi-based regimen. Imfinzi's safety profile was consistent with the known profile."Today's approval marks the first immunotherapy regimen approved in the neoadjuvant setting for gastric and gastroesophageal junction cancers -- with durvalumab demonstrating a clear overall survival benefit and opening an entirely new chapter in the treatment of early-stage disease," Yelena Y. Janjigian, M.D., from the Memorial Sloan Kettering Cancer Center in New York City and principal investigator in the MATTERHORN trial, said in a statement. "This survival benefit, observed regardless of PD-L1 status, establishes a new standard of care in this curative-intent setting."Approval of Imfinzi was granted to AstraZeneca.More Information.Sign up for our weekly HealthDay newsletter

FDA Approves Imfinzi for Early Gastric and Gastroesophageal Cancers

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