Merck's WELIREG Plus Lenvatinib Wins Positive EU CHMP Opinion: 26% Lower Risk of Progression or Death in Advanced Renal Cell Carcinoma
Merck, known as MSD outside the United States and Canada, announced on November 13 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending approval of WELIREG (belzutifan) in combination with lenvatinib for adults with advanced renal cell carcinoma with a clear cell component following treatment with an anti-PD-1/PD-L1 therapy. WELIREG is an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, and lenvatinib is the multiple receptor tyrosine kinase inhibitor discovered by Eisai. The recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway, with a final decision expected within the next two months. If approved, the combination would become the first and only approved combination of an HIF-2α inhibitor and a multi-targeted VEGFR tyrosine kinase inhibitor in the EU.
The opinion is based on the final analysis of the Phase 3 LITESPARK-011 trial, which enrolled 747 patients and compared the combination with cabozantinib. The combination reduced the risk of disease progression or death by 26% (hazard ratio 0.74, 95% CI 0.61-0.89, p=0.001), with median progression-free survival of 14.6 months versus 10.6 months. The objective response rate was 53.1% versus 40.2%, and median duration of response was 22.0 months versus 11.9 months. Overall survival showed a 15% reduction in the risk of death (hazard ratio 0.85, 95% CI 0.70-1.03), which did not reach statistical significance. The results were presented at the European Society for Medical Oncology (ESMO) Congress 2026.
The combination was approved by the U.S. Food and Drug Administration in September 2026 for the same patient population. Christina Derleth, vice president of global clinical development for oncology at Merck Research Laboratories, was among the executives presenting the announcement.
Renal cell carcinoma accounts for about nine in ten kidney cancers, and the clear cell subtype accounts for about seven in ten renal cell carcinomas. Merck cited an estimated 442,570 new kidney cancer cases and 144,871 deaths worldwide in 2024.
Source: Merck
Published by GSM · USA (original Chinese edition)
Photo: 图：透明细胞肾细胞癌组织病理切片（2级）。Mikael Häggström 摄，CC0，经 Wikimedia Commons。 / Photo: Histopathology of grade 2 clear cell renal cell carcinoma. Photo by Mikael Häggström, CC0, via Wikimedia Commons.
