Adjuvant pembrolizumab after nephrectomy in renal-cell carcinoma

T. K. Choueiri*, P. Tomczak, S. H. Park, B. Venugopal, T. Ferguson, Y. H. Chang, J. Hajek, S. N. Symeonides, J. L. Lee, N. Sarwar, A. Thiery-Vuillemin, M. Gross-Goupil, M. Mahave, N. B. Haas, P. Sawrycki, H. Gurney, C. Chevreau, B. Melichar, E. Kopyltsov, A. AlvaJ. M. Burke, G. Doshi, D. Topart, S. Oudard, H. Hammers, H. Kitamura, J. Bedke, R. F. Perini, P. Zhang, K. Imai, J. Willemann-Rogerio, D. I. Quinn, T. Powles, KEYNOTE-564 Investigators

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

BACKGROUND Patients with renal-cell carcinoma who undergo nephrectomy have no options for adjuvant therapy to reduce the risk of recurrence that have high levels of supporting evidence. METHODS In a double-blind, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with clear-cell renal-cell carcinoma who were at high risk for recurrence after nephrectomy, with or without metastasectomy, to receive either adjuvant pembrolizumab (at a dose of 200 mg) or placebo intravenously once every 3 weeks for up to 17 cycles (approximately 1 year).The primary end point was disease-free survival according to the investigator's assessment. Overall survival was a key secondary end point. Safety was a secondary end point. RESULTS A total of 496 patients were randomly assigned to receive pembrolizumab, and 498 to receive placebo. At the prespecified interim analysis, the median time from randomization to the data-cutoff date was 24.1 months. Pembrolizumab therapy was associated with significantly longer disease-free survival than placebo (disease- free survival at 24 months, 77.3% vs.68.1%; hazard ratio for recurrence or death, 0.68; 95% confidence interval [CI], 0.53 to 0.87; P = 0.002 [two-sided]).The estimated percentage of patients who remained alive at 24 months was 96.6% in the pembrolizumab group and 93.5% in the placebo group (hazard ratio for death, 0.54; 95% CI, 0.30 to 0.96).Grade 3 or higher adverse events of any cause occurred in 32.4% of the patients who received pembrolizumab and in 17.7% of those who received placebo. No deaths related to pembrolizumab therapy occurred. CONCLUSIONS Pembrolizumab treatment led to a significant improvement in disease-free survival as compared with placebo after surgery among patients with kidney cancer who were at high risk for recurrence.(Funded by Merck Sharp and Dohme, a subsidiary of Merck; KEYNOTE-564 ClinicalTrials.gov number, NCT03142334.

Original languageEnglish
Pages (from-to)683-694
Number of pages12
JournalNew England Journal of Medicine
Volume385
Issue number8
DOIs
Publication statusPublished - 19 Aug 2021

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