Belzutifan + Pembrolizumab and Post‑Nephrectomy Recurrence in ccRCC

Phase 3 results in high-risk clear cell renal cell carcinoma (ccRCC) after surgery were reported as showing a lower risk of recurrence and improved disease-free survival with a two-drug adjuvant approach.

In LITESPARK-022, a global, multicenter, double-blind, randomized phase 3 study, investigators compared belzutifan plus pembrolizumab with pembrolizumab plus placebo in 1,841 participants with ccRCC who had undergone surgery and were considered at elevated risk of recurrence.

Efficacy findings were reported at a median follow-up of 28.4 months. Pembrolizumab plus belzutifan was associated with a 28% decrease in recurrence compared with pembrolizumab plus placebo. About 81% of participants receiving the two-drug regimen were cancer-free versus 74% of those receiving standard care.