Pembrolizumab-belzutifan tied to improved disease-free survival in renal cell carcinoma

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 a 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 with 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%, respectively.

Overall survival did not differ significantly between the groups at the interim analysis, with 29% 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%, respectively. Grade 3 or higher adverse events occurred in 52.1% and 30.2% 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.

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