Regeneron’s fianlimab setback puts melanoma program at a crossroads
Regeneron’s phase 3 trial of fianlimab with Libtayo failed to beat Merck’s Keytruda as first-line therapy for unresectable melanoma, missing the primary endpoint of progression-free survival despite a numerical edge at the high dose; analysts say late separation of survival curves drove the non-significant result, signaling renewed pipeline pressure even as Regeneron pursues potential salvage paths (head-to-head vs Opdualag) and continues other programs (Factor XI, cemdisiran-pozelimab) as future catalysts.