Merck gains FDA approval for kidney cancer treatment

• Merck and Eisai received U.S. FDA approval for WELIREG plus LENVIMA to treat adults with advanced clear cell renal cell carcinoma after PD-1/PD-L1 inhibitor therapy.
• The Phase 3 LITESPARK-011 trial showed the combination reduced the risk of disease progression or death by 26% compared with cabozantinib.
• Merck and Eisai said the approval adds a new treatment option targeting different biological pathways for certain advanced kidney cancer patients.

Merck (NYSE:MRK) and Eisai received U.S. Food and Drug Administration approval for the combination of WELIREG (belzutifan) and LENVIMA (lenvatinib) to treat adults with advanced clear cell renal cell carcinoma after PD-1 or PD-L1 inhibitor therapy.

The approval was based on Phase 3 LITESPARK-011 trial data, which showed the treatment combination achieved a median progression-free survival of 14.6 months compared with 10.6 months for cabozantinib in patients with advanced kidney cancer.

“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,” said Dr. Robert Motzer, Principal Investigator and Genitourinary Medical Oncologist at Memorial Sloan Kettering Cancer Center.

The trial showed WELIREG plus LENVIMA reduced the risk of disease progression or death by 26% compared with cabozantinib, with a hazard ratio of 0.74, while the combination achieved an objective response rate of 53% compared with 40% for cabozantinib.

Merck develops pharmaceutical products across areas including oncology, vaccines, and infectious diseases, while Eisai focuses on research and development of medicines including oncology treatments.

The companies said the approval expands the use of their combination approach in advanced renal cell carcinoma, while WELIREG and LENVIMA continue to be evaluated across additional cancer treatment settings.