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 high-dose fianlimab combination versus Opdualag (nivolumab and relatlimab-rmbw) is ongoing

TARRYTOWN, N.Y., May 15, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) 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.

	High-Dose Combination (n=508)	Low-Dose Combination (n=422)	Pembrolizumab Monotherapy (n=462)	Cemiplimab Monotherapy* (n=154)
Primary endpoint: median PFS, months (95% Confidence Interval [CI])	11.5 (6.3, 16.8)	9.6 (6.2, 13.9)	6.4 (4.4, 11.1)	6.3 (4.0, 17.2)
Hazard Ratio (95% CI) Relative to Pembrolizumab	0.845 (0.709, 1.008)	0.931 (0.773, 1.122)#
p-Value	p=0.0627	p=0.4661#

*Cemiplimab was used to define contribution of components and was not used in the statistical comparison
^# Low dose combination compared against subset of concurrently randomized patients on pembrolizumab (n=421)

Detailed results from the trial will be presented at an upcoming medical meeting.

A Phase 3 head-to-head trial, also in first-line unresectable or metastatic melanoma, evaluating the high-dose fianlimab combination versus Opdualag (nivolumab and relatlimab-rmbw) is ongoing.

The potential uses of fianlimab and cemiplimab described above are investigational, and safety and efficacy of this combination have not been evaluated by any regulatory authority.

About the Phase 3 Trial

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