Regeneron Pharmaceuticals announced Thursday that its Phase 3 trial evaluating fianlimab plus cemiplimab as a first-line treatment for advanced melanoma did not meet its primary endpoint.
The trial failed to show statistically significant improvement in progression-free survival compared to pembrolizumab monotherapy.
The high-dose combination showed a median progression-free survival of 11.5 months vs. 6.4 months for pembrolizumab, but the p-value of 0.0627 did not reach significance.
Regeneron stock has declined 9.4% year-to-date, but Bond.az analysis suggests the company remains undervalued.
The trial enrolled 1,546 patients, and no new safety signals were identified.
