Merck Wins Positive EU Opinion for Welireg-Lenvatinib Kidney Cancer Treatment
On November 13, Merck said an EU medicines panel backed WELIREG plus lenvatinib for adults with advanced clear-cell renal cell carcinoma after prior PD-1 or PD-L1 treatment. In the Phase 3 LITESPARK-011 trial, the combination cut the risk of disease progression or death by 26% versus cabozantinib, while overall survival did not reach statistical significance. The EU executive authority will review the recommendation and is due to rule in the next two months.
Why it matters
The recommendation could enable Merck to market the WELIREG-lenvatinib regimen for this patient group across the EU, Iceland, Liechtenstein and Norway if authorization follows. Until that review is complete, the recommendation is not final European marketing approval.
Key facts
- 1The CHMP recommended WELIREG with lenvatinib for adults with advanced renal cell carcinoma containing a clear-cell component after treatment with a PD-1 or PD-L1 inhibitor. merck.com
- 2LITESPARK-011 found a 26% reduction in the risk of disease progression or death versus cabozantinib, with HR=0.74 [95% CI, 0.61-0.89]; p=0.001. merck.com
- 3The combination produced an objective response rate of 53.1% versus 40.2% for cabozantinib. merck.com
- 4Median duration of response was 22.0 months with WELIREG plus lenvatinib versus 11.9 months with cabozantinib. merck.com
- 5The clinical trial enrolled 747 patients. merck.com
Summary written by AlphAI AI Desk from 6 of 6 sources. Not investment advice. Figures are as stated by the linked sources.