FAILED TRIAL: Ph 3 Trial of Fianlimab Combination in 1L Unresectable or Metastatic Melanoma did not reach statistical significance for PFS improvement

Regeneron Pharmaceuticals, Inc. today reviewed results from the Phase 3 trial evaluating two dose levels of fianlimab (LAG-3 inhibitor) in combination with cemiplimab (PD-1 inhibitor) as a first-line treatment for patients with unresectable locally advanced or metastatic melanoma. The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS) compared to pembrolizumab (PD-1 inhibitor) monotherapy. No new safety signals were identified with the fianlimab combination.

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