AstraZeneca’s cancer drug Imfinzi has received FDA approval to treat early-stage stomach cancer patients both before and after surgery. This makes Imfinzi the first immunotherapy drug approved for use in the perioperative setting of stomach cancer.
Imfinzi can now be given with standard chemotherapy called FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) before surgery. After surgery, patients can continue Imfinzi with chemotherapy and eventually take Imfinzi alone as maintenance therapy.
“This approval marks a new era for patients with early stomach and gastroesophageal junction cancers,” said Dave Fredrickson, AstraZeneca’s EVP of oncology. He highlighted that Imfinzi plus FLOT offers a lasting survival benefit that grows over time.
Strong Clinical Trial Results Support Approval
The FDA’s decision followed AstraZeneca’s Phase 3 Matterhorn trial, which included 948 patients with stage 2 to 4a resectable stomach and gastroesophageal cancers. Imfinzi combined with FLOT before and after surgery lowered the risk of cancer returning, worsening, or death by 29 percent compared to chemotherapy alone.
Matterhorn was the first Phase 3 immunotherapy trial to show a significant improvement in event-free survival for early-stage stomach cancer patients.
The latest analysis, presented in 2025, showed that 69 percent of patients treated with Imfinzi were alive after three years. This compared to 62 percent survival in patients given only chemotherapy, reflecting a 22 percent reduced risk of death.
Importantly, this survival benefit was consistent regardless of patients’ PD-L1 status, a biomarker related to immune response.
Experts Praise the New Treatment Option
Dr. Josep Tabernero, principal investigator in the Matterhorn study, said recurrence is common in early stomach cancer, and long-term outcomes have been poor despite surgery and chemotherapy. “With these results, Imfinzi should become the new standard of care,” he added.
Stomach cancer ranks as the fifth most common cancer worldwide and the fifth leading cause of cancer deaths. Its incidence is increasing among younger adults. In 2025, about 43,000 patients in the US, Europe, and Japan received treatment for early-stage stomach or gastroesophageal cancers.
Imfinzi’s Growing Role in Cancer Care
Imfinzi has already been approved for perioperative use in early-stage non-small cell lung cancer and muscle-invasive bladder cancer. This new approval strengthens AstraZeneca’s position in treating early-stage cancers where cure is the goal.
Beyond perioperative use, AstraZeneca is advancing Imfinzi for bladder cancer and other indications. The drug generated $1.6 billion in sales in the third quarter of 2025.
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