Novel Immunotherapy Regimen Approved for Early-Stage Gastric Cancer
FDA Clears Perioperative Durvalumab Plus FLOT Chemotherapy for Resectable Gastric and GEJ Cancers
The U.S. Food and Drug Administration (FDA) has granted approval for the use of Durvalumab (an immunotherapy) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) for treating adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.
This regimen represents the first immunotherapy approach approved for resectable gastric and GEJ cancers, marking a major breakthrough in the treatment of these diseases, which had seen no significant advancements in approximately two decades.
The approved treatment regimen is administered perioperatively, meaning it spans before and after surgery, and includes:
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Neoadjuvant Therapy (Pre-surgery): Durvalumab combined with chemotherapy.
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Adjuvant Therapy (Post-surgery): Durvalumab combined with chemotherapy, followed by Durvalumab as monotherapy.
Data Basis from Phase III MATTERHORN Trial:
The approval is founded on positive data from the Phase III clinical trial, MATTERHORN. Final analysis results regarding overall survival (OS) demonstrated a statistically significant and clinically meaningful benefit compared to chemotherapy alone:
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Risk Reduction: The Durvalumab plus FLOT perioperative regimen reduced the risk of death by 22% compared to chemotherapy alone (HR 0.78).
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Estimated Survival: At the three-year mark, estimated survival was 69% for the Durvalumab-based regimen, versus 62% for the FLOT-only group.
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New Standard of Care: This survival benefit was observed regardless of the tumor’s PD-L1 status, establishing a new standard of care in this curative-intent setting.
Researchers and company executives emphasized that this perioperative approach (adding immunotherapy before and after surgery, followed by immunotherapy maintenance) constitutes a meaningful change, given the historically poor prognosis where about three out of four patients typically relapsed within the first two years. This approval opens an entirely new chapter in the management of early-stage disease.
