WILMINGTON, DE — The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab) in the treatment of resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. If approved, IMFINZI would become the first immunotherapy-based perioperative treatment in this setting.
The application is supported by results from the Phase III MATTERHORN trial, which showed a statistically significant 29% reduction in the risk of disease progression, recurrence, or death compared to chemotherapy alone. The study, presented at the 2025 American Society of Clinical Oncology (ASCO) meeting and published in The New England Journal of Medicine, highlighted the potential of the IMFINZI-based regimen to extend event-free survival and improve long-term outcomes.
“This Priority Review reinforces the potential for a perioperative approach with IMFINZI to transform care,” said Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca. She emphasized the high recurrence rates in gastric and GEJ cancer even after curative-intent surgery.
The FDA’s Priority Review designation, alongside a previously granted Breakthrough Therapy Designation, underscores the agency’s recognition of IMFINZI’s potential to address a serious unmet medical need. A regulatory decision is expected by the fourth quarter of 2025.
The MATTERHORN trial regimen included neoadjuvant IMFINZI and chemotherapy prior to surgery, followed by adjuvant therapy with IMFINZI and chemotherapy, then IMFINZI alone. Event-free survival rates at 24 months reached 67.4% for the IMFINZI group, compared to 58.5% for the control.
While overall survival data remain immature, early trends favor the IMFINZI regimen. Safety profiles and surgical completion rates were comparable across treatment arms, with no unexpected adverse events reported.
Regulatory submissions are also underway in the EU, Japan, and several other markets, signaling AstraZeneca’s global ambitions for this new treatment approach in gastric and GEJ cancers, which remain among the top five cancer-related causes of death worldwide.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.