Imfinzi Secures EU Approval with 29% Survival Improvement
On March 17, 2026, the European Commission approved AstraZeneca's blockbuster drug Imfinzi (durvalumab) for treating resectable, early-stage gastric and gastroesophageal junction (GEJ) cancers. The approval covers a perioperative regimen where Imfinzi is administered with standard FLOT chemotherapy before surgery, followed by Imfinzi monotherapy after surgery. This decision provides a significant new treatment option in a therapeutic area with high unmet needs and high recurrence rates.
The approval is supported by robust data from the Phase III MATTERHORN trial. The study demonstrated that the Imfinzi-based regimen led to a statistically significant 29% reduction in the risk of disease progression, recurrence, or death (event-free survival) compared to chemotherapy alone. It also showed a 22% improvement in overall survival. The clinical benefit is poised to shift medical practice.
In MATTERHORN, nearly 70% of patients were still alive three years after treatment with the durvalumab-based perioperative regimen. 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.
— Josep Tabernero, Principal Investigator, Vall d'Hebron Institute of Oncology.
Approval Solidifies Lead Over Merck's Keytruda
This regulatory win strategically positions AstraZeneca ahead of its primary competitor, Merck (MSD). Merck's rival PD-1 inhibitor, Keytruda, failed to demonstrate a significant improvement in event-free survival in its own KEYNOTE-585 trial for the same patient population. The distinct success of the MATTERHORN trial gives Imfinzi a clear competitive advantage and reinforces its standing in the immuno-oncology landscape, which also includes Bristol Myers Squibb's Opdivo.
The financial implications for AstraZeneca are substantial. Imfinzi is a cornerstone of the company's oncology division, a segment that already constitutes over 40% of total revenue. The drug's sales topped $6 billion in 2025, marking a 28% increase from the prior year. This new EU indication, which covers an estimated 15,500 drug-treated patients annually, provides another growth driver for one of the company's most important assets.
Edgen Stock·Mar 17 2026, 15:59
