FDA Approves Durvalumab Added to Perioperative FLOT for Resectable Gastric and GEJ Cancer

Overview

• Approval covers durvalumab with FLOT before and after surgery followed by durvalumab maintenance, using a 1500 mg every-4-weeks schedule aligned with the MATTERHORN regimen.
• MATTERHORN showed a 29% reduction in risk of progression, recurrence, or death versus FLOT alone, with median event-free survival not reached versus 32.8 months.
• The 24-month event-free survival rate was 67.4% with durvalumab plus FLOT compared with 58.5% with FLOT alone.
• Pathological complete response occurred in 19.2% of patients receiving durvalumab plus FLOT versus 7.2% with FLOT alone, a statistically significant improvement.
• Safety was consistent with known profiles, with grade 3 or 4 adverse events in 71.6% with durvalumab versus 71.2% with placebo and similar rates of surgical delays and adjuvant therapy timing.