Incyte Reports Positive Results for PD-1 Inhibitor Zynyz in Two Phase 3 Clinical Trials

1. Positive Results: Incyte announced positive topline results from two Phase 3 clinical studies evaluating retifanlimab (Zynyz), a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1), in squamous cell anal carcinoma (SCAC) and non-small cell lung cancer (NSCLC).
2. Phase 3 Trials: The Phase 3 PODIUM-303 study in SCAC met its primary endpoint of progression-free survival, and the Phase 3 PODIUM-304 study in NSCLC met its primary endpoint of overall survival.
3. Safety Profile: The safety analysis from both studies demonstrated that retifanlimab was generally well-tolerated with no new safety signals observed.
4. Future Plans: Incyte plans to share the Phase 3 data from both studies in the second half of 2024.
5. Previous Approval: Zynyz received FDA approval for the treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in March 2023.