03160nam a2200289 4500 ESSALUD 20260804122828.0 ta t pe ||||| |||| 00| 0 spa d BMG eng Choueiri, Toni K. Autor 53653 Adjuvant pembrolizumab plus belzutifan for renal-cell carcinoma páginas: 32-43 Background: Adjuvant pembrolizumab improves disease-free and overall survival among patients with resected clear-cell renal-cell carcinoma. The hypoxia-inducible factor 2α inhibitor belzutifan has activity in advanced disease. Adjuvant pembrolizumab with belzutifan may further improve outcomes in patients with clear-cell renal-cell carcinoma at increased risk for recurrence. Methods: In this phase 3, double-blind trial, we randomly assigned participants in a 1:1 ratio to receive intravenous pembrolizumab at a dose of 400 mg every 6 weeks (≤9 doses) and either daily oral belzutifan at a dose of 120 mg (pembrolizumab–belzutifan) or placebo (pembrolizumab–placebo) for up to 1 year. The primary end point was disease-free survival as assessed by the investigator; secondary end points included overall survival and safety. Results: A total of 921 participants were assigned to receive pembrolizumab–belzutifan and 920 were assigned to receive pembrolizumab–placebo. The median time from randomization to the data-cutoff date (August 23, 2025) was 28.4 months (range, 15.0 to 40.1). Disease-free survival was significantly higher with pembrolizumab–belzutifan than with pembrolizumab–placebo (hazard ratio for disease recurrence or death, 0.72; 95% confidence interval [CI], 0.59 to 0.87; two-sided P<0.001); the estimated 24-month disease-free survival was 80.7% and 73.7%, respectively. At this interim analysis with 29% of the final-analysis events observed, overall survival did not differ significantly between the groups (hazard ratio for death, 0.78; 95% CI, 0.51 to 1.19; two-sided P=0.24); the estimated 24-month overall survival was 96.2% with pembrolizumab–belzutifan and 95.7% with pembrolizumab–placebo. Adverse events of grade 3 or higher occurred in 52.1% of the participants who received pembrolizumab–belzutifan and in 30.2% of those who received pembrolizumab–placebo. Conclusions: Treatment with pembrolizumab–belzutifan led to significantly higher disease-free survival, with a greater risk of grade 3 or higher toxic effects, than treatment with pembrolizumab monotherapy after nephrectomy in participants with clear-cell renal-cell carcinoma at increased risk for recurrence. CÁNCER GENITOURINARIO 53654 NEFROLOGÍA GENERAL 53655 TRATAMIENTOS DE ONCOLOGÍA 53656 Motzer, Robert J. 53657 Karam, Jose A. 53658 Yip, Wesley 53659 Suárez, Cristina 53660 Ye, Dingwei 53661 He, Zhisong 53662 22717 22634 Massachusetts NEJM Group NEJM001 The New England Journal of Medicine ESSALUD 0028-4793 ARTICULOS 2026-07-31 sqb 22723 22723