Merck and Eisai Secure FDA Approval for Welireg-Lenvima Combination

Merck and Eisai have secured FDA approval for Welireg (belzutifan) in combination with Lenvima (lenvatinib) to treat adults with advanced renal cell carcinoma that has a clear cell component, but has already been treated with a PD-1 or PD-L1 inhibitor.

The dual oral regimen is the first approved combination of a HIF-2α inhibitor and a multi-targeted VEGFR tyrosine kinase inhibitor in this setting. The approval was based on the Phase III LITESPARK-011 study, which compared belzutifan plus lenvatinib with cabozantinib.

The combination reduced the risk of disease progression or death by 26% versus cabozantinib, with a median progression-free survival of 14.6 months compared to 10.6 months. Objective response rates were 53% and 40%, respectively.