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Phase 3 trial of fianlimab combo in melanoma misses primary goal but shows 5.1-month PFS gain vs pembrolizumab.

Company Fundamentals
15 May 2026
GlobeNewsWire
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Regeneron's Phase 3 trial testing fianlimab (LAG-3 inhibitor) combined with cemiplimab (PD-1 inhibitor) as first-line treatment for unresectable or metastatic melanoma did not achieve statistical significance for its primary endpoint of improved progression-free survival (PFS) compared to pembrolizumab alone. However, the high-dose combination showed a numeric improvement of 5.1 months in median PFS. No new safety concerns were reported. A separate Phase 3 trial comparing this high-dose combination to Opdualag is ongoing, with full trial results to be presented at a future medical meeting.

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