The U.S. Food and Drug Administration (FDA) approved Merck’s Welireg (belzutifan) in combination with Eisai’s Lenvima (lenvatinib) for adults with advanced renal cell carcinoma (RCC). This treatment is indicated for patients whose kidney cancer progressed following PD-1 or PD-L1 inhibitor immunotherapy.
The approval is based on the Phase 3 LITESPARK-011 trial which enrolled 747 patients. The study showed the Welireg-Lenvima combination significantly improved progression-free survival. This result demonstrated statistical superiority over the current standard-of-care treatment, cabozantinib.