Imfinzi Gains U.S. Approval as First Perioperative Immunotherapy for Early Gastric Cancers
AstraZeneca’s Imfinzi (durvalumab), combined with FLOT chemotherapy, has been approved in the United States for adults with resectable early-stage and locally advanced gastric and gastroesophageal junction cancers.
The regimen involves treatment with Imfinzi and chemotherapy before surgery, followed by further combined therapy after surgery, then Imfinzi alone.
The approval follows Priority Review by the FDA and is supported by event-free and overall survival results from the Phase III MATTERHORN trial. Gastric cancer remains a major global health challenge, with close to one million people diagnosed each year.
Despite surgery and chemotherapy, many patients experience recurrence, highlighting the need for more effective perioperative treatment options.
In MATTERHORN, the Imfinzi-based regimen reduced the risk of disease progression, recurrence or death by 29% compared with chemotherapy alone.
Median event-free survival was not reached in the Imfinzi arm but was 32.8 months with chemotherapy only. Overall survival was also improved, with a 22% reduction in the risk of death. Survival benefits were observed regardless of PD-L1 status.
The safety profile was consistent with previous data for Imfinzi and FLOT, with similar rates of severe adverse events in both arms. The FDA reviewed the submission under Project Orbis, and additional regulatory reviews are under way in several countries.
