Fianlimab + cemiplimab phase 3 (first-line melanoma)
A second LAG-3 blocker failed to beat pembrolizumab alone, a warning that the Opdualag result is not automatically a class effect.
Regeneron reported that the trial missed its primary PFS endpoint; the high-dose combination improved median PFS numerically by 5.1 months but not significantly. Differences from RELATIVITY-047 include the comparator (pembrolizumab rather than nivolumab), the antibody, and dosing. The adjuvant fianlimab phase 3 continues.
Setting
Untreated unresectable or metastatic melanoma: fianlimab + cemiplimab (two dose levels) vs pembrolizumab
Phase
Phase 3
Sponsor
Regeneron
Registry
Headline result
Primary PFS endpoint not met; numerical +5.1 months median PFS at the high dose.
Reported
2026