The U.S. Food and Drug Administration has approved AstraZeneca’s (LSE:AZN) immunotherapy Imfinzi (durvalumab) for adults with resectable stomach and gastroesophageal junction (GEJ) cancers. The treatment is authorized for use alongside standard chemotherapy before and after surgery, and then as a standalone therapy in the post-surgical phase, the company announced Wednesday.
The decision is supported by data from the Phase III MATTERHORN study, which demonstrated that combining Imfinzi with chemotherapy reduced the risk of cancer recurrence, progression, or death by 29% compared with chemotherapy on its own. The regimen also led to a 22% reduction in the risk of death. Three years after treatment, 69% of patients receiving the Imfinzi-based protocol were still alive, versus 62% in the chemotherapy-only group.
MATTERHORN enrolled 948 participants across 176 medical centers in 20 countries. Patients received several cycles of Imfinzi plus chemotherapy ahead of surgery, followed by additional combination cycles afterwards, and then up to 10 cycles of Imfinzi alone. The study primarily evaluated disease-free survival and overall survival outcomes.
Safety profiles were consistent across both treatment arms: serious side effects occurred in about 72% of patients in each group, and most participants were able to undergo their scheduled operations.
Stomach cancer remains one of the most fatal cancers globally, ranking as the fifth-leading cause of cancer-related deaths and accounting for nearly one million new cases per year. Despite available treatments, recurrence rates are high, and fewer than half of patients survive five years post-diagnosis. In 2024, an estimated 6,500 U.S. patients received drug therapy for early-stage stomach or GEJ cancer.
The FDA evaluated Imfinzi under Project Orbis, a collaborative framework that enables simultaneous regulatory reviews across multiple countries. The therapy is also being considered by regulators in Australia, Canada, Switzerland, the EU, Japan, and several other jurisdictions.
Imfinzi is designed to enhance the immune system’s ability to identify and destroy cancer cells and already carries approvals for a range of other malignancies, including liver, bile duct, lung, and bladder cancers.
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