Merck Wins FDA Approval for Kidney Cancer Combo WELIREG and LENVIMA
Pharmaceutical giant Merck has secured US FDA approval for its kidney cancer treatment combination, WELIREG (belzutifan) plus LENVIMA (lenvatinib), to be used in adults with advanced clear cell renal cell carcinoma after PD-1 or PD-L1 inhibitor therapy.
The approval was granted based on Phase 3 LITESPARK-011 trial data, which showed the combination achieved a median progression-free survival of 14.6 months compared to 10.6 months for cabozantinib in patients with advanced kidney cancer.
According to Dr. Robert Motzer, Principal Investigator and Genitourinary Medical Oncologist at Memorial Sloan Kettering Cancer Center, 'While there has been much progress in the first-line treatment of advanced kidney cancer, we have limited options to offer patients if the disease progresses after treatment with a PD-1/PD-L1 immunotherapy.'
The trial demonstrated that WELIREG plus LENVIMA reduced the risk of disease progression or death by 26% compared to cabozantinib, with a hazard ratio of 0.74, while achieving an objective response rate of 53% compared to 40% for cabozantinib.