Pharma giant AstraZeneca’s Imfinzi, combined with standard FLOT chemotherapy, has won US FDA approval for patients with resectable early and locally advanced gastric and gastroesophageal junction cancers. 

 

This is a first-of-its-kind immunotherapy regimen in the neoadjuvant setting that dramatically improves survival.

 

The regimen includes neoadjuvant Imfinzi with chemotherapy before surgery, followed by adjuvant Imfinzi plus chemotherapy, and then Imfinzi monotherapy for adults with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.

 

The approval, granted through the FDA’s Priority Review, is based on compelling data from the Phase III MATTERHORN trial showing significant improvements in both event-free survival (EFS) and overall survival (OS). EFS results were highlighted in the plenary session at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine, while OS findings were presented at the 2025 European Society for Medical Oncology (ESMO) Congress.

 

Gastric cancer ranks as the fifth leading cause of cancer death worldwide, with nearly one million new diagnoses annually. In 2024, approximately 6,500 U.S. patients received drug treatment for early-stage or locally advanced gastric or GEJ cancer.

 

“This approval ushers in a new clinical paradigm for patients with early gastric and gastroesophageal junction cancers, with Imfinzi plus FLOT delivering a durable survival benefit that increases over time,” said Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca.

 

"As the third US approval for a perioperative Imfinzi-based regimen, this milestone further validates the perioperative approach and underscores our focus on bringing novel treatments to early-stage cancers where cure is the goal.”

 

Yelena Y Janjigian, MD, Chief Attending Physician of the Gastrointestinal Medical Oncology Service at Memorial Sloan Kettering Cancer Center and principal investigator of MATTERHORN, added: “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."

 

"Nearly seven in 10 patients were alive at three years following treatment with the durvalumab-based perioperative regimen. This survival benefit, observed regardless of PD-L1 status, establishes a new standard of care in this curative-intent setting.”

 

Patient advocate Aki Smith, Founder and Executive Director of Hope for Stomach Cancer, said: “From personal experience as a caregiver to my father, I know that for too long patients diagnosed with early gastric or gastroesophageal junction cancer have faced a high risk of their cancer returning, even after undergoing surgery and therapy intended to cure it. Today’s approval represents a major step forward in improving outcomes and offering renewed hope to those affected by this devastating disease.”

 

The US approval followed review under Project Orbis, which enables concurrent regulatory assessment across participating countries. AstraZeneca’s Imfinzi and FLOT perioperative regimen is also under review in Australia, Canada, and Switzerland for the same indication.