More adverse events of grade 3 or higher reported for participants receiving pembrolizumab-belzutifan than pembrolizumab-placebo
MONDAY, July 6, 2026 (HealthDay News) — For patients with clear-cell renal cell carcinoma, pembrolizumab-belzutifan yields significantly higher disease-free survival, according to a study published in the July 2 issue of the New England Journal of Medicine.
Toni K. Choueiri, M.D., from the Dana-Farber Cancer Institute in Boston, and colleagues randomly assigned participants with resected clear-cell renal cell carcinoma to receive intravenous pembrolizumab at a dose of 400 mg every six weeks and either daily oral belzutifan at a dose of 120 mg (pembrolizumab-belzutifan) or placebo (pembrolizumab-placebo) for up to one year (921 and 920 participants, respectively).
The median time from randomization to data cutoff was 28.4 months. The researchers observed significantly higher disease-free survival with pembrolizumab-belzutifan than pembrolizumab-placebo (hazard ratio for disease recurrence or death, 0.72; 95 percent confidence interval, 0.59 to 0.87; two-sided P < 0.001), with estimated 24-month disease-free survival of 80.7 and 73.7 percent, respectively. Overall survival did not differ significantly between the groups at the interim analysis with 29 percent of the final-analysis events observed (hazard ratio for death, 0.78; 95 percent confidence interval, 0.51 to 1.19; two-sided P = 0.24), with estimated 24-month overall survival of 96.2 and 95.7 percent, respectively. Grade 3 or higher adverse events occurred in 52.1 and 30.2 percent of participants who received pembrolizumab-belzutifan and pembrolizumab-placebo, respectively.
“Our trial showed a disease-free survival benefit with adjuvant pembrolizumab-belzutifan as compared with pembrolizumab monotherapy for participants with renal cell carcinoma at increased risk for recurrence after nephrectomy or nephrectomy and resection of metastatic lesions,” the authors write.
Several authors disclosed ties to biopharmaceutical companies, including Merck, which manufactures belzutifan and funded the study.
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