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AstraZeneca’s Imfinzi Wins U.S. Approval for Perioperative Gastric Cancer Treatment with FLOT
FDA approved Imfinzi (durvalumab) with the standard FLOT chemotherapy regimen for adults with resectable stage II, III, or IVA gastric and gastroesophageal junction cancers. Image: hartfordhealthcare
AstraZeneca announced that the FDA approved Imfinzi (durvalumab) with the standard FLOT chemotherapy regimen for adults with resectable stage II, III, or IVA gastric and gastroesophageal junction cancers. The perioperative regimen includes neoadjuvant and adjuvant Imfinzi plus chemotherapy, followed by Imfinzi monotherapy.
Priority Review and Strong Phase III Data Drove Approval
The FDA granted Priority Review based on results from the Phase III MATTERHORN trial. The data showed significant improvements in event-free survival and overall survival. AstraZeneca presented the results at the 2025 ASCO Plenary Session, and The New England Journal of Medicine published the findings. The company also shared the data at this year’s ESMO Congress.
An interim analysis showed a 29% reduction in the risk of progression, recurrence, or death with perioperative Imfinzi. Imfinzi plus FLOT reduced the risk of death by 22% (OS HR 0.78; 95% CI 0.63–0.96; p=0.021). The three-year survival rate reached 69%, compared with 62% for chemotherapy alone.
Imfinzi did not reduce surgery completion rates. Grade ≥3 adverse events occurred at similar rates in both groups (71.6% vs. 71.2%), supporting a predictable safety profile.
Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, said the approval marks the company’s third perioperative Imfinzi regimen cleared in the U.S. He noted that Imfinzi plus FLOT provides an increasing survival benefit over time.
Dr. Yelena Y. Janjigian of Memorial Sloan Kettering Cancer Center, the study’s lead investigator, said this is the first immunotherapy approved for neoadjuvant use in gastric and GEJ cancers. She emphasized that the three-year survival rate reached nearly 70%.
A New Option for Patients as Imfinzi Global Reviews Advance
AstraZeneca highlighted that gastric cancer remains the fifth leading cause of cancer death worldwide, with nearly one million new cases each year. In 2024, about 6,500 U.S. patients with early or locally advanced gastric or GEJ cancer received systemic therapy. Recurrence after curative-intent treatment remains a major concern.
Aki Smith, founder of Hope for Stomach Cancer, said many patients still relapse after surgery and chemotherapy. She called the FDA approval an important new source of hope for patients and families.
The application joined the FDA’s Project Orbis program, enabling simultaneous review across multiple health authorities. Australia, Canada, and Switzerland are reviewing the same indication. Regulators in the EU, Japan, and other countries have also accepted submissions.
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