AstraZeneca’s Imfinzi (durvalumab), in combination with standard of care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel), has been approved by the US FDA to treat adult patients with resectable, early-stage and locally advanced gastric and gastro-oesophageal junction (GEJ) cancers.
The approval follows a Priority Review from the FDA, and is based on results from the MATTERHORN phase 3 trial, which enrolled participants in 176 centres across 20 countries.
In an interim analysis, patients receiving the Imfinzi/FLOT combination had a 29% reduced risk of disease progression, recurrence or death versus chemotherapy alone. An estimated 78.2% of patients treated with the Imfinzi/FLOT combination were event-free at one year, compared to 74% in the FLOT-only arm.
In the final analysis, results showed that treatment with the Imfinzi/FLOT combination reduced the risk of death by 22% compared to chemotherapy alone. An estimated 69% of patients treated with the Imfinzi/FLOT combination were alive at three years, compared with 62% in the FLOT-only arm.
Gastric cancer is the fifth most common cancer in the world; it is also the fifth-highest cause of cancer deaths. In 2022, nearly one million new patients were diagnosed with gastric cancer, and approximately 660,000 deaths were reported globally from the disease. GEJ is a type of gastric cancer that occurs where the oesophagus connects to the stomach. In 2024, there were around 43,000 patients in the US, EU and Japan with early-stage and locally advanced gastric or GEJ cancer.
Recurrence and relapse are common in patients with resectable gastric cancer and survival rates remain poor, with less than half of gastric cancer patients alive at five years.
Imfinzi is already approved, in combination with chemotherapy, as a treatment for both small cell and non-small cell lung cancers, as well as bladder cancer and endometrial cancer, under specific circumstances.
Dave Fredrickson, executive vice president of the Oncology Haematology Business Unit at AstraZeneca, said: “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. 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.”