The Food and Drug Administration granted approval for belzutifan (Welireg, Merck & Co., Inc.) on December 14, 2023, for patients with advanced renal cell carcinoma (RCC) who have previously received 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 effectiveness was assessed in LITESPARK-005 (NCT04195750), a study where 746 patients with unresectable locally advanced or metastatic clear cell RCC were randomly assigned to different treatments after progressing following a PD-1 or PD-L1 checkpoint inhibitor and a VEGF-TKI. Participants were randomly assigned in a 1:1 ratio to receive either 120 mg of belzutifan or 10 mg of everolimus once a day. Randomization was categorized based on International Metastatic RCC Database Consortium risk group and the quantity of preceding VEGF-TKIs.
The primary effectiveness measures were progression-free survival (PFS) evaluated by blinded independent central review and overall survival (OS).
Belzutifan showed a statistically significant improvement in progression-free survival (PFS) compared to everolimus, with a hazard ratio of 0.75 (95% CI: 0.63, 0.90) and a one-sided p-value of 0.0008. The Kaplan-Meier curves showed non-proportional risks with comparable median progression-free survival estimates of 5.6 months (95% CI: 3.9, 7.0) in the belzutifan group and 5.6 months (95% CI: 4.8, 5.8) in the everolimus group. Although the OS data were incomplete at the current study, with 59% of fatalities reported, no negative trend was detected. An examination of patient-reported symptoms and functional outcomes indicated that belzutifan was better tolerated than everolimus.
The predominant adverse effects (≥25% occurrence) observed in patients treated with belzutifan included reduced hemoglobin levels, fatigue, musculoskeletal pain, elevated creatinine levels, decreased lymphocyte count, elevated alanine aminotransferase levels, reduced sodium levels, elevated potassium levels, and increased aspartate aminotransferase levels.
The suggested belzutifan dosage is 120 mg taken orally once a day until disease progression or intolerable toxicity.
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