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Regeneron Provides Update on Phase 3 Trial of Fianlimab (LAG-3 Inhibitor) Combination in First-Line Unresectable or Metastatic Melanoma

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  • Regeneron's Phase 3 trial of high-dose fianlimab combined with cemiplimab versus pembrolizumab monotherapy for first-line unresectable or metastatic melanoma did not reach statistical significance for the primary endpoint of progression-free survival (PFS).
  • A numeric improvement of 5.1 months in median PFS was observed for the high-dose fianlimab combination (11.5 months) compared to pembrolizumab monotherapy (6.4 months).
  • The hazard ratio for the high-dose combination relative to pembrolizumab was 0.845 with a p-value of 0.0627, falling short of the threshold for statistical significance.
  • No new safety signals were identified with the fianlimab combination during the trial.
  • A separate Phase 3 head-to-head trial evaluating the high-dose fianlimab combination versus Opdualag is currently ongoing.
  • The study enrolled 1,546 patients randomized to receive high-dose combination, low-dose combination, pembrolizumab, or cemiplimab monotherapy.
  • Detailed results from the trial will be presented at an upcoming medical meeting.
  • The potential uses of fianlimab and cemiplimab remain investigational as safety and efficacy have not been evaluated by any regulatory authority.