Regeneron Pharmaceuticals Inc. (REGN) announced results from its Phase 3 trial evaluating two dose levels of fianlimab, a LAG-3 inhibitor, in combination with cemiplimab, a PD-1 inhibitor, as a first-line treatment for patients with unresectable locally advanced or metastatic melanoma. The study did not achieve statistical significance for the primary endpoint of progression-free survival (PFS) improvement compared with pembrolizumab monotherapy.
No new safety signals were identified with the fianlimab combination. However, a numeric improvement of 5.1 months in median PFS was observed for the high-dose fianlimab combination compared to pembrolizumab.
A separate Phase 3 head-to-head trial is ongoing, evaluating the high-dose fianlimab combination against Opdualag (nivolumab and relatlimab-rmbw) in first-line unresectable or metastatic melanoma.
The randomized, double-blind Phase 3 trial is investigating the combination of fianlimab and cemiplimab versus pembrolizumab in patients 12 years of age or older with unresectable locally advanced or metastatic melanoma who have not received a previous systemic treatment for advanced disease. The trial enrolled 1,546 patients who were randomized to receive either: 1600 mg fianlimab and 350 mg cemiplimab (high-dose combination) every 3 weeks; 400 mg fianlimab and 350 mg cemiplimab (low-dose combination) every 3 weeks; placebo and 200 mg pembrolizumab every 3 weeks; or placebo and 350 mg cemiplimab every 3 weeks.
REGN closed Friday's regular trading at $698.25 down $14.62 or 2.05%.
For More Such Health News, visit rttnews.com.
For comments and feedback contact: editorial@rttnews.com
Business News
May 15, 2026 15:25 ET Apart from the confirmation of Kevin Warsh as the next Fed chair, the main news on the economics front this week included key price data from the U.S. and the first quarter economic growth figures from major economies. Both consumer prices and producer costs have started to reflect the effect of supply shocks due to the Middle East conflict. In Europe, GDP data was in focus, while inflation data from China dominated the news flow in Asia.