FDA approves Merck’s Welireg plus Eisai’s Lenvima for previously treated advanced clear cell kidney cancer
MRK•The FDA approved Welireg plus Lenvima for adults with advanced clear cell renal cell carcinoma whose disease progressed on a PD-1 or PD-L1 inhibitor. In a phase 3 trial, median progression-free survival was 14.6 months versus 10.6 months with cabozantinib; overall survival did not reach statistical significance at final analysis.
1. Trial results
The phase 3 LITESPARK-011 trial found median progression-free survival of 14.6 months with Welireg plus Lenvima, compared with 10.6 months with cabozantinib (hazard ratio 0.74). The objective response rate was 53% versus 40%, while overall survival missed statistical significance at final analysis.
