FDA Approves WELIREG Plus LENVIMA for Advanced RCC Patients

Merck and Eisai have announced that their dual oral regimen of WELIREG (belzutifan) plus LENVIMA (lenvatinib) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with advanced renal cell carcinoma (RCC) with a clear cell component who have previously received a PD-1/PD-L1 inhibitor.

The approval is based on data from the Phase 3 LITESPARK-011 trial, which showed that WELIREG plus LENVIMA led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to cabozantinib. The median PFS was 14.6 months for patients receiving WELIREG plus LENVIMA versus 10.6 months for those receiving cabozantinib.

WELIREG is a first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, and this approval marks the first time it has been combined with LENVIMA, a multi-targeted VEGFR-TKI. The combination therapy has also demonstrated a statistically significant improvement in objective response rate (ORR), with an ORR of 53% for patients receiving WELIREG plus LENVIMA versus 40% for those receiving cabozantinib.