Welireg

Welireg (belzutifan) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). The recommended dose for belzutifan is 120 mg once daily.

In the LITESPARK-005 trial, an open-label, randomized, head-to-head clinical trial with 746 patients, Welireg demonstrated a statistically significant and clinically meaningful improvement in Progression-Free Survival (PFS) compared to everolimus, with a median PFS of 5.6 months and a PFS Hazard Ratio of 0.75 (p-value 0.0008). The median time to event for PFS was 24.1 weeks. At the first interim analysis (IA1), the median time to event for Overall Survival (OS) was 97.1 weeks, with 44% of patients experiencing an event.

Safety findings for the belzutifan arm included a 3.2% rate of deaths due to adverse events, 6% treatment discontinuation due to treatment-emergent adverse events (TEAEs), and 39% dose interruption due to TEAEs. Decreased hemoglobin (all grades) was observed in 93% of patients. The regulatory action recommended was Traditional Approval, with a PDUFA Goal Date of 1/17/2024.