Merck gains EU backing after 26% risk reduction
Key points
- Merck (NYSE:MRK) received a positive recommendation from the European Medicines Agency's CHMP for WELIREG plus lenvatinib to treat adults with advanced clear-cell kidney cancer following PD-1 or PD-L1 inhibitor treatment.
- The Phase 3 LITESPARK-011 trial showed a 26% reduction in the risk of disease progression or death compared with cabozantinib, although the overall survival endpoint did not achieve statistical significance.
- The European Commission is expected to make its final decision within two months, potentially making the combination the first approved HIF-2α inhibitor and VEGFR-TKI combination in the European Union.
Merck (NYSE:MRK) received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for WELIREG (belzutifan) combined with lenvatinib to treat adults with advanced clear-cell renal cell carcinoma following PD-1 or PD-L1 inhibitor treatment.
The recommendation follows results from the Phase 3 LITESPARK-011 trial, which showed that the combination reduced the risk of disease progression or death by 26% compared with cabozantinib, although the overall survival endpoint did not achieve statistical significance.
"Patients with advanced renal cell carcinoma in the European Union have limited treatment options if their disease progresses following anti-PD-1 or anti-PD-L1 therapy," said Dr. Christina Derleth, Vice President of Global Oncology Clinical Development at Merck Research Laboratories.
The trial enrolled 747 patients and reported an objective response rate of 53.1% for WELIREG plus lenvatinib, compared with 40.2% for cabozantinib, while median duration of response reached 22 months against 11.9 months.
The European Commission is expected to issue its final decision within two months, and Merck stated that approval would make the combination the first and only approved HIF-2α inhibitor and multi-targeted VEGFR-TKI combination in the European Union.
The combination received U.S. FDA approval in September 2026 for previously treated advanced clear-cell renal cell carcinoma, while Merck reported that WELIREG sales increased 58% to $307 million in the third quarter of 2026.
Frequently asked questions (FAQ)
Editorial note: The positive CHMP opinion is a recommendation, not final European marketing authorization. Although progression-free survival improved significantly, overall survival did not meet the trial's statistical significance threshold. The European Commission's decision remains pending.
