Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) announced on Monday that the US Food and Drug Administration has accepted and granted Priority Review to its supplemental Biologics License Application for IMFINZI (durvalumab) for patients with resectable, early-stage and locally advanced gastric and gastro-oesophageal junction cancers.

The application is supported by positive data from the MATTERHORN Phase III trial and has also been granted Breakthrough Therapy Designation.

The MATTERHORN trial demonstrated a statistically significant and clinically meaningful event-free survival benefit with a perioperative IMFINZI-based regimen compared to chemotherapy alone. Patients treated with the IMFINZI regimen showed a 29% reduction in risk of disease progression, recurrence or death, with a hazard ratio of 0.71.

At 12 months, 78.2% of patients on the IMFINZI regimen were event-free compared to 74.0% in the control group; at 24 months, rates were 67.4% versus 58.5%, indicating increasing benefit over time. A favourable trend was also observed for overall survival, with a hazard ratio of 0.78.

Safety outcomes were consistent with the known profiles of IMFINZI and FLOT chemotherapy, and surgical completion rates were similar between both groups.

If approved, IMFINZI would become the first and only perioperative immunotherapy-based regimen in this setting. Regulatory reviews are ongoing in the European Union, Japan and other markets.