For patients across the European Union facing a diagnosis of early-stage gastric or gastroesophageal junction cancers, a new treatment option now offers a significant and hopeful shift in their care journey. A novel perioperative regimen, combining the immunotherapy drug durvalumab with standard FLOT chemotherapy, has received approval, marking the first immunotherapy-based treatment available in this early, potentially curable setting. This approach is administered both before and after surgery with the goal of eliminating any lingering cancer cells, aiming to prevent the disease's return and improve long-term survival for patients.
The approval is grounded in the compelling results of the global MATTERHORN Phase III trial, which demonstrated a clear and durable survival benefit. The data showed that adding durvalumab to chemotherapy reduced the risk of disease progression, recurrence, or death by 29% compared to chemotherapy alone. Most importantly, the treatment showed a 22% reduction in the risk of death, with an estimated 69% of patients treated with the immunotherapy regimen alive at three years, compared to 62% of those receiving only chemotherapy. Notably, the survival curves continued to separate over time, indicating the benefit of this treatment grows stronger the longer patients are followed. "In MATTERHORN, nearly 70 per cent of patients were still alive three years after treatment with the durvalumab-based perioperative regimen," said Dr. Josep Tabernero, principal investigator of the trial. "This EU approval brings patients the first immunotherapy regimen to extend survival in this early setting and is poised to become the new standard of care."
This news is particularly impactful given the challenging nature of these cancers. Gastric cancer is a leading cause of cancer death globally, and despite undergoing surgery with curative intent and chemotherapy, recurrence rates remain high. The introduction of an effective immunotherapy option in the perioperative window addresses a critical unmet need, offering a new pathway to improve outcomes. The safety profile for the combination was consistent with the known effects of each medicine, and the percentage of patients able to complete surgery was similar to those on chemotherapy alone, supporting its integration into current treatment paradigms.
The approval in Europe represents a major step in a broader global effort to transform care for early-stage cancers. Dave Fredrickson of AstraZeneca highlighted that this marks the third perioperative approval in Europe for a durvalumab-based regimen, underscoring a focused commitment on early disease intervention where cure is the ultimate goal. With regulatory applications still under review in several other countries, the hope is that this treatment will soon become accessible to many more patients worldwide who are battling these aggressive gastrointestinal cancers.