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AstraZeneca PLC (NASDAQ:AZN) announced Wednesday that the US Food and Drug Administration has approved Imfinzi (durvalumab) in combination with FLOT chemotherapy as a perioperative treatment for adult patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. This information is based on a press release statement included in a recent SEC filing.
The approval follows a Priority Review and is supported by results from the Phase III MATTERHORN trial. In the study, the Imfinzi regimen showed a 29% reduction in the risk of disease progression, recurrence or death, and a 22% reduction in the risk of death compared to chemotherapy alone. The estimated three-year overall survival rate was 69% for patients receiving the Imfinzi-based regimen, compared to 62% for those receiving chemotherapy only.
The approved regimen consists of neoadjuvant Imfinzi with chemotherapy before surgery, followed by adjuvant Imfinzi with chemotherapy, and then Imfinzi monotherapy. The trial enrolled 948 patients with Stage II, III, or IVA gastric or GEJ cancers.
The safety profile of Imfinzi combined with FLOT chemotherapy was consistent with known profiles of each medicine. The percentage of patients completing surgery and the rate of grade 3 or higher adverse events were similar between the Imfinzi and control groups.
The regulatory submission was reviewed under Project Orbis, a framework for concurrent submission and review of oncology medicines among participating international partners. The Imfinzi and FLOT perioperative regimen is also under review by regulatory authorities in Australia, Canada, Switzerland, the European Union, Japan, and several other countries.
Gastric cancer is the fifth leading cause of cancer death globally. In 2024, there were approximately 6,500 drug-treated patients with early-stage and locally advanced gastric or GEJ cancer in the US, according to data cited in the filing.
Imfinzi is a human monoclonal antibody that targets the PD-L1 protein and is already approved for multiple indications in oncology. The MATTERHORN trial results were presented at major oncology conferences and published in The New England Journal of Medicine.
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