AstraZeneca’s Imfinzi perioperative regimen recommended for approval for patients with early gastric and gastroesophageal cancers

Imfinzi in combination with standard-of-care FLOT chemotherapy has been recommended for approval in the EU for the treatment of adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction cancers. The CHMP of the European Medicines Agency based its positive opinion on event-free survival (EFS) and overall survival data from the MATTERHORN Phase III trial.

Note that in 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. Estimated median EFS was not yet reached for the Imfinzi arm versus 32.8 months for the comparator arm.

The results demonstrated a statistically significant and clinically meaningful survival improvement, reducing the risk of death by 22% compared to chemotherapy alone. An estimated 69% of patients treated with the Imfinzi-based regimen were alive at three years compared with 62% in the comparator arm. At each subsequent prespecified OS landmark, the survival curves indicated increasing separation, signaling a greater magnitude of benefit over time for the Imfinzi-based regimen.

Josep Tabernero, MD, PhD, head of the Medical Oncology Department at Vall d’Hebron University Hospital and director of the Vall d’Hebron Institute of Oncology (VHIO) in  Barcelona, Spain, and principal investigator in the MATTERHORN trial, said: This recommendation signals a major step forward for patients in the EU with early gastric and gastroesophageal junction cancers, who have historically faced high rates of recurrence and poor long-term outcomes despite curative-intent surgery and chemotherapy. This durvalumab-based perioperative regimen is the first immunotherapy approach to significantly extend survival in this setting, and if approved, should set a new standard of care.”

Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “Imfinzi plus FLOT demonstrated a durable, increasing long-term survival benefit in the MATTERHORN trial, with more than two-thirds of patients alive at three years. The CHMP recommendation marks further progress toward our goal to offer novel approaches in early-stage cancers where there is the greatest chance for cure and brings us closer to providing the third perioperative Imfinzi-based regimen in the EU.”

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Related Topics and Keywords

gastric cancer, gastroesophageal cancers, Imfinzi, Imfinzi perioperative