By: IPP Bureau
Last updated : July 31, 2025 11:05 am
For patients with resectable early-stage gastric and gastroesophageal junction cancers
AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has been accepted and granted Priority Review in the US for treating patients with resectable, early-stage, and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers.The FDA grants Priority Review to medicines that may offer major improvements over existing treatments. The FDA action date is expected in Q4 2025.Imfinzi also received Breakthrough Therapy Designation (BTD), which accelerates the review of treatments for serious conditions with unmet medical needs.Gastric cancer is the fifth most common and fifth deadliest cancer globally. In 2024, around 6,500 patients in the US were treated for early-stage and locally advanced gastric or GEJ cancer.
Susan Galbraith, EVP, Oncology R&D, AstraZeneca, said: “This Priority Review highlights Imfinzi’s potential to change care for patients with early gastric and GEJ cancers, who face high risk of recurrence even after surgery and chemotherapy. If approved, this would be the first immunotherapy-based regimen to show a significant reduction in disease progression, recurrence, or death in this setting.”
The sBLA is based on results from the Phase III MATTERHORN trial, presented at ASCO 2025 and published in The New England Journal of Medicine.
In the trial, patients received Imfinzi with chemotherapy before and after surgery, followed by Imfinzi alone. This regimen reduced the risk of disease progression, recurrence, or death by 29% compared to chemotherapy alone (HR: 0.71; CI: 0.58–0.86; p<0.001). At one year, 78.2% of patients on the Imfinzi-based regimen were event-free vs. 74.0% with chemotherapy alone. At two years, rates were 67.4% vs. 58.5%.
A positive trend in overall survival was also observed (HR: 0.78; CI: 0.62–0.97; p=0.025). Final OS results are pending.
The safety profile was consistent with known effects, and surgery completion rates were similar across treatment arms.
Regulatory reviews based on these results are ongoing in the EU, Japan, and other countries.