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Fianlimab/cemiplimab for melanoma (HARMONY)

Trial
Focused scale · updates evenly spaced
60%53.8%47.5%41.3%35%Oct 6Oct 6Oct 6 16:53 UTC • YES 48.5%Oct 6 17:05 UTC • YES 48.5%
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Will this trial show a positive result on objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on blinded independent central review (BICR)?

YES48¢
NO52¢

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

The trial did not reach statistical significance for the primary endpoint of improvement in progression-free survival (PFS) A numeric improvement of 5.1 months in median PFS was observed for the high-dose fianlimab combination compared to pembrolizumab monotherapy Phase 3 head-to-head trial of the

Trial Results • Phase 3Results event Fri, May 15, 2026, 8:19 PM EDTMatched fianlimab, cemiplimab, melanoma, drug