Topline results from two phase III clinical studies evaluating retifanlimab (Zynyz),in squamous cell anal carcinoma (SCAC) and non-small cell lung cancer (NSCLC)

The Phase III PODIUM-303 study in SCAC met its primary endpoint of progression free survival and the Phase III PODIUM-304 study in NSCLC met its primary endpoint of overall survival. The safety analysis from both studies demonstrated that retifanlimab was generally well-tolerated with no new safety signals observed. Incyte plans to share the Phase III data from both studies in the second half of 2024.

POD1UM-303 is a Phase III, global, multicenter, randomized, double-blind study evaluating carboplatin-paclitaxel with retifanlimab or placebo in patients with inoperable locally recurrent or metastatic SCAC who have not previously been treated with chemotherapy. POD1UM-304 is a Phase III, global, multicenter, randomized, double-blind study evaluating platinum-based chemotherapy with retifanlimab or placebo in patients with first-line, metastatic squamous or non-squamous NSCLC.