Merck gets positive EU CHMP opinion for belzutifan–lenvatinib in advanced ccRCC
- The CHMP recommended the combination for adults with advanced clear-cell renal cell carcinoma after anti-PD-1 or anti-PD-L1 treatment.
- The European Commission will review the recommendation; a decision is expected within two months.
- In the Phase 3 LITESPARK-011 trial, progression-free survival improved significantly, with a 26% lower risk of progression or death versus cabozantinib.
- Overall survival did not reach statistical significance; objective response rates were 53.1% versus 40.2%.
EU regulatory review
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of WELIREG (belzutifan) with lenvatinib for adults with advanced renal cell carcinoma with a clear cell component (ccRCC) following treatment with a PD-1 or PD-L1 inhibitor. The European Commission will review the recommendation for the EU, Iceland, Liechtenstein and Norway, with a decision expected within two months.
Phase 3 results
The recommendation is based on the LITESPARK-011 trial, in which the combination reduced the risk of disease progression or death by 26% versus cabozantinib (HR 0.74; 95% CI 0.61–0.89; p=0.001). Overall survival, the other dual primary endpoint, did not meet statistical significance; the combination reduced the risk of death by 15% (HR 0.85; 95% CI 0.70–1.03).
At final analysis, the objective response rate was 53.1% with the combination versus 40.2% with cabozantinib. Median duration of response was 22.0 months and 11.9 months, respectively.
Trial design
LITESPARK-011 enrolled 747 patients and compared oral belzutifan (120 mg once daily) plus lenvatinib (20 mg once daily) with cabozantinib (60 mg once daily). Participants had locally advanced or metastatic ccRCC that had progressed during or after PD-1/PD-L1 inhibitor treatment, or within six months of completing adjuvant PD-1 inhibitor therapy.
Source: Merck