On 11/25/2025 the FDA approved durvalumab for use in combination with perioperative chemotherapy for adult patients with resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma.
Approval is based on results from the phase 3 MATTERHORN trial, which demonstrated a significant improvement in event-free survival with the addition of durvalumab to standard perioperative FLOT chemotherapy compared with chemotherapy alone.
Durvalumab is administered in combination with neoadjuvant and adjuvant chemotherapy, with the option to continue durvalumab as monotherapy if chemotherapy is discontinued for non-progression reasons.
Clinical Implications:
This approval establishes perioperative chemo-immunotherapy as a new standard option for patients with resectable gastric and GEJ adenocarcinoma.