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Merck Receives Positive EU CHMP Opinion for WELIREG® (belzutifan) in Combination With Lenvatinib for Adults With Advanced Renal Cell Carcinoma With a Clear Cell Component (ccRCC) Following Treatment With an Anti-PD-1/PD-L1 Therapy

MRK
  • The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of WELIREG (belzutifan) plus lenvatinib for treating adult patients with advanced renal cell carcinoma with a clear cell component following PD-1 or PD-L1 inhibitor therapy.
  • If approved, this regimen will be the first and only combination of a HIF-2α inhibitor and a multi-targeted VEGFR-TKI authorized in the European Union.
  • The recommendation is based on positive progression-free survival results from the Phase 3 LITESPARK-011 trial, which showed a 26% reduction in the risk of disease progression or death (HR=0.74) compared to cabozantinib.
  • In the LITESPARK-011 trial, the combination achieved an objective response rate of 53.1% versus 40.2% for cabozantinib, with a median duration of response of 22.0 months versus 11.9 months.
  • Overall survival results for the combination did not meet statistical significance compared to cabozantinib, showing a 15% risk reduction in death (HR=0.85).
  • A final marketing authorization decision by the European Commission is expected within the next two months for the EU, Iceland, Liechtenstein, and Norway.
  • The combination of WELIREG and lenvatinib was previously approved by the U.S. FDA in September 2026 for the same patient population based on the same trial data.
  • Common adverse reactions in the combination trial included anemia (87%), fatigue, and hypoxia (16%).
  • Serious cardiac dysfunction, including heart failure, occurred in 6% of patients receiving the combination, with a median time to onset of 26 weeks.
  • WELIREG carries a warning for embryo-fetal toxicity, requiring effective non-hormonal contraception due to potential contraceptive failure.
  • Lenvatinib, developed by Eisai, is a multiple receptor tyrosine kinase inhibitor that inhibits VEGFR1, VEGFR2, VEGFR3, FGFR1-4, PDGFRα, KIT, and RET.
  • Merck and Eisai maintain a strategic collaboration for the worldwide co-development and commercialization of lenvatinib in combination with Merck's WELIREG.