Shots:
- The US FDA has approved Welireg + Lenvima for the treatment of adults with advanced renal cell carcinoma with a clear cell component (ccRCC) following a PD-1 or PD-L1 inhibitor
- Approval was based on the P-III (LITESPARK-011) trial assessing Welireg (120mg, PO, QD) + Lenvima (20mg, PO, QD) vs cabozantinib in 747 pts with advanced ccRCC whose disease progressed on or after anti-PD-1/ PD-L1 therapy
- Trial met its 1EP of improved PFS by 26% (mPFS: 14.6 vs 10.6mos.), while the other 1EP of OS did not meet statistical significance. 2EPs showed ORR of 53% vs 40% plus DoR results were also reported
Ref: Businesswire | Image: Merck & Eisai | Press Release
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