Adjuvant pembrolizumab after nephrectomy in renal-cell carcinoma

Toni K. Choueiri, Piotr Tomczak, Se Hoon Park, Balaji Venugopal, Thomas Ferguson, Yen Hwa Chang, Jaroslav Hajek, Stefan N. Symeonides, Jae Lyun Lee, Naveed Sarwar, Antoine Thiery-Vuillemin, Marine Gross-Goupil, Mauricio Mahave, Naomi B. Haas, Piotr Sawrycki, Howard Gurney, Christine Chevreau, Bohuslav Melichar, Evgeniy Kopyltsov, Ajjai AlvaJohn M. Burke, Gurjyot Doshi, Delphine Topart, Stephane Oudard, Hans Hammers, Hiroshi Kitamura, Jens Bedke, Rodolfo F. Perini, Pingye Zhang, Kentaro Imai, Jaqueline Willemann-Rogerio, David I. Quinn, Thomas Powles

Research output: Contribution to journalArticlepeer-review

294 Scopus citations


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 number, NCT03142334.

Original languageEnglish (US)
Pages (from-to)683-694
Number of pages12
JournalNew England Journal of Medicine
Issue number8
StatePublished - 2021

ASJC Scopus subject areas

  • Medicine(all)


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