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NEW YORK - AstraZeneca’s Imfinzi (durvalumab) has received U.S. Food and Drug Administration approval as the first immunotherapy for perioperative treatment of early-stage and locally advanced gastric and gastroesophageal junction cancers, according to a company press release issued Wednesday.
The approved regimen combines Imfinzi with standard FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) before and after surgery, followed by Imfinzi monotherapy. The treatment is indicated for adult patients with resectable Stage II, III, and IVA disease.
FDA approval followed Priority Review based on results from the Phase III MATTERHORN trial, which demonstrated a 29% reduction in the risk of progression, recurrence or death compared to chemotherapy alone. The trial also showed a 22% reduction in the risk of death with the Imfinzi regimen.
In the final overall survival analysis, approximately 69% of patients treated with the Imfinzi-based regimen were alive at three years compared to 62% in the chemotherapy-only arm. The survival benefit was observed regardless of PD-L1 status.
"This approval ushers in a new clinical paradigm for patients with early gastric and gastroesophageal junction cancers," said Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Haematology Business Unit, in the statement.
The safety profile was consistent with known profiles of each medicine, with similar rates of Grade 3 or higher adverse events between the Imfinzi plus chemotherapy arm (71.6%) and the chemotherapy-only arm (71.2%).
Gastric cancer is the fifth leading cause of cancer death globally, with nearly one million people diagnosed annually. In 2024, approximately 6,500 patients in the U.S. were treated for early-stage and locally advanced gastric or gastroesophageal junction cancer.
The application is also under review by regulatory authorities in Australia, Canada, Switzerland, the European Union, Japan, and several other countries.
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