Reported Earlier, Incyte's Retifanlimab (Zynyz) Shows Median PFS of 9.3 Months vs 7.4 With Placebo In SCAC Phase 3 Study Published In The Lancet Following May 2025 FDA Approval

Benzinga · 06/13 07:25
  • POD1UM-303/InterAACT 2 is the first and largest global Phase 3 trial evaluating a PD-1 inhibitor in combination with chemotherapy for the treatment of patients with advanced SCAC not previously treated with systemic chemotherapy
  • The trial met its primary endpoint; treatment with retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel) resulted in clinically meaningful improvements in progression-free survival and overall survival
  • In May 2025, the U.S. Food and Drug Administration (FDA) approved Zynyz® (retifanlimab-dlwr) in combination with carboplatin and paclitaxel and as a single agent for the treatment of advanced SCAC; submissions to other global regulatory agencies are also under review