**Summary**
AstraZenecas Imfinzi (durvalumab) has been approved in the European Union (EU) as the first and only perioperative immunotherapy for patients with early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. The approval is based on positive results from the MATTERHORN Phase III trial, which demonstrated significant improvements in event-free survival (EFS) and overall survival (OS) compared to chemotherapy alone. The regimen includes Imfinzi in combination with FLOT chemotherapy before and after surgery, followed by Imfinzi monotherapy.
Key findings from the MATTERHORN trial include
A 29% reduction in the risk of disease progression, recurrence, or death with the Imfinzi-based regimen.
An estimated 69% of patients were alive at three years with Imfinzi, compared to 62% in the comparator arm.
The safety profile was consistent with known profiles of the individual medicines.
This approval marks AstraZenecas third perioperative approval in Europe for an Imfinzi-based regimen, highlighting the companys commitment to improving outcomes in early-stage cancers where cure is possible. Gastric cancer, the fifth leading cause of cancer death globally, affects nearly one million people annually, with approximately 15,500 drug-treated patients in the EU in 2024. The approval is expected to set a new standard of care for these patients.
Imfinzi is also approved in the US and other countries for this indication, with regulatory applications under review in Japan and several other countries. AstraZeneca continues to expand its immuno-oncology portfolio, focusing on innovative therapies to transform cancer care across various tumor types and stages.