Phase 3 Melanoma Trial Misses Primary EndpointThe trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS) compared to Merck & Co. Inc. (NYSE:MRK) Keytruda (pembrolizumab) monotherapy.High-dose fianlimab combination showed a numerically higher median progression-free survival of 11.5 months compared to 6.4 months on Keytruda, but failed statistically with a p-value of 0.0627.Low-dose combination showed a progression-free survival of 9.6 months, with a p-value of 0.4661.No new safety signals were identified with the fianlimab combination.The randomized, double-blind Phase 3 trial is investigating the combination of fianlimab and cemiplimab versus pembrolizumab in patients 12 years of age or older with unresectable locally advanced or metastatic melanoma who have not received a previous systemic treatment for advanced disease.Trial Design And EnrollmentThe trial enrolled 1,546 patients to receive either:
1600 mg fianlimab and 350 mg cemiplimab (high-dose combination).
400 mg fianlimab and 350 mg cemiplimab (low-dose combination).
Placebo and 200 mg pembrolizumab or placebo and 350 mg cemiplimab.
