Welcome back! We continue with good news in the world of oncology. The FDA has recently approved a new treatment option that promises to improve the prognosis of patients with stomach cancer and gastroesophageal junction cancer.
On November 25, 2025, the FDA gave the green light to durvalumab (brand name Imfinzi, by AstraZeneca) for use in combination with chemotherapy.
Who benefits from this approval?
This therapy is directed at adult patients with:
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Gastric adenocarcinoma or
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Adenocarcinoma of the gastroesophageal junction (GEJ)
What is crucial about this approval is that it focuses on resectable disease (i.e., operable). The treatment is administered in a neoadjuvant manner (before surgery) and adjuvant (after surgery), marking an important difference in the comprehensive management of these patients.
The Evidence: MATTERHORN Study
The approval is supported by the results of the MATTERHORN clinical trial, a rigorous study that included 948 patients with stage II to IVA disease.
The study compared the use of durvalumab combined with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) versus placebo with the same chemotherapy. The findings were very positive:
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Better event-free survival: The group that received durvalumab had a significant improvement, reducing the risk of disease progression or recurrence by 29% (Hazard Ratio of 0.71).
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Complete response: The rate of pathological complete response (i.e., absence of detectable cancer in the tissue removed after surgery) was 19.2% with durvalumab, compared to only 7.2% in the control group.
Treatment Details and Safety
To ensure the best outcome, it is important to follow the administration guidelines:
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Regimen: It is administered together with chemotherapy before and after surgery, followed by durvalumab as a single agent to complete treatment.
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Recommended dose: Generally 1,500 mg every 4 weeks for patients weighing ≥30 kg.
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Precautions: As an immunotherapy, there are risks of immune-mediated reactions, infusion reactions, and fetal toxicity, so medical monitoring is essential.
A Step Forward
This approval is a milestone because it introduces immunotherapy in earlier stages of resectable gastric cancer, offering patients a greater probability of eliminating the disease and avoiding long-term relapses.
With information from: FDA
What's Next?
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