FDA Approves Merck's WELIREG Plus LENVIMA for Advanced RCC
The U.S. FDA has approved Merck's (NYSE: MRK) WELIREG® (belzutifan), in combination with LENVIMA® (lenvatinib), for the treatment of certain previously treated adult patients with advanced renal cell carcinoma (RCC) having a clear cell component.
The approval is based on data from the Phase 3 LITESPARK-011 trial. In this study, WELIREG plus LENVIMA resulted in a statistically significant and clinically meaningful improvement in progression-free survival (PFS), reducing the risk of disease progression or death by 26%, compared to cabozantinib.
While overall survival did not meet statistical significance at final analysis, WELIREG plus LENVIMA demonstrated a statistically significant improvement in objective response rate with an ORR of 53% versus 40% for cabozantinib. Data on duration of response were also reported.
The safety and efficacy of the combination have not been established in patients with left ventricular ejection fraction (LVEF) below 50%. Monitor patients for symptoms or signs of heart failure, and if present, reassess LVEF. Withhold and resume at a reduced dose upon recovery to baseline or Grade 1 or permanently discontinue based on severity.