FDA Greenlights Merck-Eisai Combination for Advanced Kidney Cancer
The US FDA has granted approval to the combination of Merck's Welireg (belzutifan) and Eisai's Lenvima (lenvatinib) for treating advanced renal cell carcinoma, the most common form of kidney cancer. This decision is based on the Phase 3 LITESPARK-011 trial, which showed that the combination reduced the risk of disease progression or death by 30% compared to cabozantinib, a standard targeted therapy.
The median progression-free survival for patients on the combination was 14.8 months versus 10.7 months for those on cabozantinib, and 52.6% responded to treatment compared to 39.6% on the standard therapy.
Welireg is a first-in-class HIF-2α inhibitor that blocks a protein helping tumours adapt to low-oxygen conditions, while Lenvima is a multi-targeted kinase inhibitor cutting off a tumour's blood supply.