Regeneron Pharmaceuticals, Inc. (REGN) on Friday announced results from its Phase 3 trial evaluating Fianlimab, a LAG-3 inhibitor studied in combination with Cemiplimab for first-line unresectable or metastatic melanoma who have not received prior systemic therapy.
Phase 3 Trial of Fianlimab
The randomized, double-blind study enrolled more than 1,500 patients with unresectable locally advanced or metastatic melanoma who had not received prior systemic therapy. Patients were treated with either high-dose Fianlimab plus Cemiplimab, low-dose Fianlimab plus Cemiplimab, pembrolizumab monotherapy, Cemiplimab monotherapy.
The trial did not reach statistical significance for the primary endpoint of progression-free survival compared to pembrolizumab. However, a numeric improvement of 5.1 months in median progression-free survival was observed with the high-dose Fianlimab combination. Importantly, no new safety signals were identified.
Regeneron stated that detailed data will be presented at an upcoming medical meeting. In addition, a separate Phase 3 head-to-head trial of the high-dose Fianlimab combination versus Opdualag (nivolumab and relatlimab-rmbw) is ongoing.
REGN has traded between $476.49 and $821.11 over the past year. The stock closed Friday's trading (May 15, 2026) at $698.25, down 2.05%. During overnight trading, the stock is at $654.75, down 6.23%.
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