Berlin, Germany – March 16, 2026 – In a significant advancement for the treatment of gastric and gastroesophageal cancers, AstraZeneca’s Imfinzi (durvalumab) has received approval from the European Commission in combination with standard-of-care FLOT chemotherapy. This marks the first and only perioperative immunotherapy authorized in the EU for patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers.
The approval is based on the robust findings of the MATTERHORN Phase III trial, published in The New England Journal of Medicine, which demonstrated statistically significant and clinically meaningful improvements in both event-free survival and overall survival for patients undergoing treatment with the Imfinzi-FLOT regimen. This combination therapy involves two cycles of Imfinzi alongside chemotherapy before surgery, followed by further chemotherapy and then Imfinzi monotherapy post-surgery.
A New Standard of Care for Gastric Cancer
Gastric cancer remains a formidable global health challenge, ranking as the fifth leading cause of cancer-related deaths worldwide. Approximately one million people are diagnosed with the disease each year, according to AstraZeneca. In 2024, an estimated 15,500 patients in the EU were receiving drug treatment for early-stage and locally advanced gastric or GEJ cancers. Despite curative-intent surgery and chemotherapy, recurrence rates remain high, creating an urgent need for improved long-term survival outcomes.
“Despite curative-intent surgery and chemotherapy, patients with resectable gastric and gastroesophageal cancers still face high recurrence rates and an urgent need for improved long-term survival,” stated Dr. Josep Tabernero, head of the Medical Oncology Department at Vall d’Hebron University Hospital and director of the Vall d’Hebron Institute of Oncology (VHIO) in Barcelona, Spain, and principal investigator in the MATTERHORN trial. “In MATTERHORN, nearly 70 per cent of patients were still alive three years after treatment with the durvalumab-based perioperative regimen.”
Understanding the MATTERHORN Trial Results
The MATTERHORN trial’s results are particularly encouraging. An interim analysis revealed a 29% reduction in the risk of disease progression, recurrence, or death in patients receiving the Imfinzi-based perioperative regimen compared to those receiving chemotherapy alone. After one year, approximately 78.2% of patients treated with the Imfinzi combination remained event-free, compared to 74.0% in the control group. At the two-year mark, event-free survival rates were around 67.4% for the Imfinzi-treated group versus 58% for those receiving chemotherapy alone.
The regimen utilizes FLOT chemotherapy, a combination of fluorouracil, leucovorin, oxaliplatin, and docetaxel, which is already a standard treatment approach. Adding Imfinzi, an immune checkpoint inhibitor, aims to enhance the body’s own immune response to target and eliminate cancer cells, both before and after surgical resection.
What is Perioperative Immunotherapy?
Perioperative immunotherapy refers to the administration of immunotherapy drugs – in this case, Imfinzi – both before and after surgery. This approach is designed to prime the immune system to recognize and attack any remaining cancer cells after surgery, potentially reducing the risk of recurrence. The goal is to improve long-term survival rates by harnessing the power of the patient’s own immune system.
Imfinzi’s Expanding Role in Oncology
This EU approval further solidifies Imfinzi’s position as a key oncology medicine within AstraZeneca’s portfolio. Imfinzi is already approved for several other cancer types, including non-small cell lung cancer and bladder cancer, demonstrating its versatility and potential across a range of malignancies. The expansion of its label to include early gastric and gastroesophageal cancers represents a significant step forward in addressing unmet medical needs in this patient population.
The European Commission’s decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), highlighting the rigorous scientific evaluation and the compelling evidence supporting the efficacy and safety of the Imfinzi-FLOT combination.
Impact on Patients and Future Directions
The approval of Imfinzi in combination with FLOT chemotherapy offers a new hope for patients facing resectable, early-stage, and locally advanced gastric and GEJ cancers. The potential to significantly improve event-free and overall survival rates is a major breakthrough. Dr. Tabernero believes this approval “brings patients the first immunotherapy regimen to extend survival in this early setting and is poised to become the new standard of care.”
While this approval represents a major step forward, ongoing research is crucial to further refine treatment strategies and identify biomarkers that can predict which patients are most likely to benefit from this immunotherapy approach. Future studies may as well explore the potential of combining Imfinzi with other therapies to further enhance treatment outcomes.
The availability of this new treatment option is expected to improve the quality of life and long-term prognosis for thousands of patients across the European Union battling these challenging cancers.
Key Takeaways:
- AstraZeneca’s Imfinzi, combined with FLOT chemotherapy, has been approved in the EU for early and locally advanced gastric and gastroesophageal cancers.
- The approval is based on the MATTERHORN Phase III trial, demonstrating improved event-free and overall survival.
- This represents the first perioperative immunotherapy approved for this cancer type in the EU.
- The treatment involves Imfinzi administered before and after surgery, alongside standard chemotherapy.
The next step will be the widespread implementation of this new treatment protocol across EU member states, ensuring that eligible patients have access to this potentially life-saving therapy. Further updates on availability and reimbursement will be released by national health authorities in the coming months.
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