The U.S. Food and Drug Administration approved AstraZeneca’s immunotherapy IMFINZI (durvalumab) in combination with the standard FLOT chemotherapy regimen for adult patients with resectable, early‑stage or locally advanced gastric and gastroesophageal junction cancers on November 25, 2025. The approval makes IMFINZI the first perioperative immunotherapy to receive regulatory clearance for this disease area.
The decision was based on the Phase III MATTERHORN trial, which enrolled 1,000 patients across 30 sites. Patients receiving IMFINZI plus FLOT before surgery and IMFINZI after surgery experienced a 29 % reduction in the risk of disease progression, recurrence or death, and a 22 % reduction in the risk of death compared with chemotherapy alone. Event‑free survival and overall survival were the primary endpoints, and the trial demonstrated a statistically significant improvement in both metrics, underscoring the clinical benefit of adding immunotherapy to standard perioperative care.
Gastric cancer is the fifth leading cause of cancer death worldwide, with nearly one million new cases diagnosed annually. The approval opens a sizable market; estimates place the global addressable market for perioperative gastric and GEJ therapies at roughly $3 billion annually. By securing first‑mover status, AstraZeneca positions IMFINZI to capture a meaningful share of this unmet need, potentially generating substantial new revenue streams for the company’s oncology portfolio.
Current treatment options for early‑stage gastric and GEJ cancers are limited to chemotherapy and surgery, with no approved immunotherapy in the perioperative setting. Competitors such as Roche’s pembrolizumab and Merck’s nivolumab have approvals in metastatic disease but not in the perioperative context. The IMFINZI approval therefore gives AstraZeneca a distinct competitive advantage and may prompt rivals to accelerate development of similar combinations.
Management emphasized the strategic significance of the approval. Executive Vice President Dave Fredrickson 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.” The decision aligns with AstraZeneca’s broader focus on expanding its gastrointestinal oncology pipeline and reinforces the company’s commitment to bringing innovative immunotherapies to high‑need patient populations.
While the approval itself does not include new financial guidance, the addition of a first‑in‑class therapy is expected to strengthen AstraZeneca’s oncology revenue mix and support future growth. The company’s oncology segment has historically driven a significant portion of its top‑line performance, and the IMFINZI approval is likely to enhance its competitive positioning and long‑term value proposition.
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