Regeneron's fianlimab combo Phase 3 trial misses primary endpoint

Regeneron Pharmaceuticals announced that its Phase 3 trial evaluating fianlimab in combination with cemiplimab as a first-line treatment for unresectable locally advanced or metastatic melanoma did not meet its primary endpoint of statistical significance for progression-free survival (PFS). Despite the miss, a numeric improvement of 5.1 months in median PFS was observed for the high-dose combination compared to pembrolizumab monotherapy. No new safety signals were identified, and a head-to-head Phase 3 trial against Opdualag is currently underway.