Merck wins FDA approval for Welireg–Lenvima kidney-cancer combination

Merck ($MRK) received FDA approval for Welireg plus Lenvima as an oral treatment for adults with advanced clear-cell renal cell carcinoma after a PD-1 or PD-L1 inhibitor. The decision adds a treatment option for patients whose kidney cancer has progressed following immunotherapy and is supported by the Phase 3 LITESPARK-011 trial.

Among 747 participants, median progression-free survival was 14.6 months with the combination versus 10.6 months with cabozantinib, corresponding to a 26% lower hazard of progression or death. Response rates were 53% and 40%, respectively. However, the final overall-survival comparison was not statistically significant. Serious adverse reactions occurred in 54% of combination-treated patients, and anemia and hypoxia remain important Welireg risks.

Sources:

• Merck — FDA approval and trial results, Business Wire release