U.S. FDA Approves WELIREG® (belzutifan) Plus LENVIMA® (lenvatinib) for Certain Previously Treated Adult Patients With Advanced Renal Cell Carcinoma With a Clear Cell Component (ccRCC)
The FDA approved Merck's WELIREG (belzutifan) plus Eisai's LENVIMA (lenvatinib) for adults with advanced renal cell carcinoma with a clear cell component following a PD-1/PD-L1 inhibitor. Approval is based on the Phase 3 LITESPARK-011 trial, where the combination cut the risk of progression or death by 26% versus cabozantinib (HR 0.74), with median PFS of 14.6 months versus 10.6 months and ORR of 53% versus 40%.
Key figures
- Drug Name
- WELIREG (belzutifan) plus LENVIMA (lenvatinib)
- Phase Of Trial
- Phase 3
- Trial
- LITESPARK-011
- Orr combination
- 53%
- Orr cabozantinib
- 40%
- Overall survival
- did not meet statistical significance
- Pfs hazard ratio
- 0.74 (95% CI, 0.61-0.89; p=0.001)
- Patients enrolled
- 747
- Pfs reduction risk
- 26%
- Median pfs combination
- 14.6 months
- Median pfs cabozantinib
- 10.6 months
AI analysis
Red flags2 · Pro
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.