The European Commission has officially approved Imfinzi (durvalumab) as the first perioperative immunotherapy for adults with early gastric and gastroesophageal junction cancers, marking a major milestone for cancer care across the region. The decision follows a positive opinion from regulatory experts and robust clinical evidence from the MATTERHORN Phase III trial.
Under the new approval, Imfinzi (durvalumab) in combination with standard‑of‑care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) can be administered before and after surgery, followed by Imfinzi monotherapy to treat resectable, early‑stage, and locally advanced (Stages II–IVA) gastric and gastroesophageal junction cancers.
Leading oncologists hailed the approval as a significant advancement in treatment options for patients with this aggressive disease, where recurrence rates remain high despite surgery and chemotherapy alone. Gastric cancer represents the fifth most common cancer worldwide and contributes substantially to global cancer mortality, creating an urgent need for more effective therapeutic strategies.
The MATTERHORN Phase III trial, which provided the core evidence supporting regulatory decisions, demonstrated that the Imfinzi (durvalumab)‑based perioperative regimen significantly improved both event‑free survival (EFS) and overall survival (OS) compared with standard chemotherapy alone. In planned interim analyses, patients receiving the regimen showed a notable 29% reduction in the risk of disease progression, recurrence, or death. Estimated survival outcomes also favored the Imfinzi arm across key time points.
“This approval marks a turning point for patients facing early gastric and gastroesophageal junction cancers, which traditionally have limited treatment options,” said Dr. Josep Tabernero, a principal investigator in the MATTERHORN trial and head of the Medical Oncology Department at Vall d’Hebron University Hospital in Barcelona. He emphasized that perioperative use of Imfinzi has the potential to set a new standard of care in this setting, offering durable survival benefits and extending disease‑free intervals.
In addition to improved survival statistics, trial data highlighted that nearly 70% of patients treated with the Imfinzi regimen were alive three years after treatment, with growing separation of survival curves over time, indicating a sustained benefit that continues to mature beyond initial observations.
The safety profile of the Imfinzi (durvalumab)‑plus‑chemotherapy regimen was consistent with the known effects of each component, and rates of surgical completion remained similar to those in the comparator group. Adverse events were manageable and aligned with expectations for perioperative chemotherapy combined with immunotherapy.
AstraZeneca, the global biopharmaceutical company behind Imfinzi, has rapidly expanded the clinical applications of this immunotherapy since its initial launch in 2017. Imfinzi is already approved in multiple cancer indications worldwide, including lung and bladder cancers, and has become one of the company’s top‑selling oncology medicines.
Dave Fredrickson, Executive Vice President of the Oncology Haematology Business Unit at AstraZeneca, noted that the EU approval builds on a growing body of evidence reinforcing Imfinzi’s role in earlier stages of disease, where improving long‑term outcomes remains a critical challenge. He added that the expanded label underscores the company’s commitment to transforming outcomes for patients through innovative therapeutic approaches.
The European Commission’s decision aligns with similar regulatory approvals in other regions, including the United States, where the Imfinzi‑based perioperative regimen received approval based on the same trial data and is already being incorporated into clinical practice. Applications for approval in additional countries, including Japan, are currently under review, reflecting a global effort to broaden access to this immunotherapy option.
Experts explained that perioperative immunotherapy represents a paradigm shift in cancer care, combining systemic immune‑based treatment with traditional surgical intervention to target microscopic disease that can contribute to relapse. By leveraging the body’s immune system to attack residual tumor cells, Imfinzi (durvalumab) aims to reduce the likelihood of recurrence and extend survival beyond what chemotherapy alone can achieve.
Patient advocacy groups welcomed the news, emphasizing that the new option offers renewed hope for earlier intervention and improved prognosis, particularly for individuals diagnosed at stages where curative treatment is still possible. They called on healthcare systems across Europe to facilitate the prompt integration of the Imfinzi regimen into standard patient care pathways.
With this approval, clinicians and patients now have access to the first immunotherapy‑based perioperative treatment for resectable gastric and gastroesophageal junction cancers in the EU, marking a noteworthy shift in the oncology landscape and strengthening the arsenal against a disease with historically poor survival rates.
