首页|Overall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma
Overall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma
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NETL
NSTL
万方数据
维普
Background:Adjuvant pembrolizumab therapy after surgery for renal-cell carcinoma was approved on the basis of a significant improvement in disease-free survival in the KEYNOTE-564 trial.Whether the results regarding overall survival from the third prespecified interim analysis of the trial would also favor pembrolizumab was uncertain.Methods:In this phase 3,double-blind,placebo-controlled trial,we randomly assigned(in a 1:1 ratio)participants with clear-cell renal-cell carcinoma who had an increased risk of recurrence after surgery to receive pembrolizumab(at a dose of 200 mg)or placebo every 3 weeks for up to 17 cycles(approximately 1 year)or until recurrence,the occurrence of unacceptable toxic effects,or withdrawal of consent.A significant improvement in disease-free survival according to investigator assessment(the primary end point)was shown previously.Overall survival was the key secondary end point.Safety was a secondary end point.Results:A total of 496 participants were assigned to receive pembrolizumab and 498 to receive placebo.As of September 15,2023,the median follow-up was 57.2 months.The disease-free survival benefit was consistent with that in previous analyses(hazard ratio for recurrence or death,0.72;95％confidence interval[CI],0.59 to 0.87).A significant improvement in overall survival was observed with pembrolizumab as compared with placebo(hazard ratio for death,0.62;95％CI,0.44 to 0.87;P = 0.005).The estimated overall survival at 48 months was 91.2％in the pembrolizumab group,as compared with 86.0％in the placebo group;the benefit was consistent across key subgroups.Pembrolizumab was associated with a higher incidence of serious adverse events of any cause(20.7％,vs.11.5％with placebo)and of grade 3 or 4 adverse events related to pembrolizumab or placebo(18.6％vs.1.2％).No deaths were attributed to pembrolizumab therapy.Conclusions:Adjuvant pembrolizumab was associated with a significant and clinically meaningful improvement in overall survival,as compared with placebo,among participants with clear-cell renal-cell carcinoma at increased risk for recurrence after surgery.
Toni K Choueiri
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Merck Sharp and Dohme,a subsidiary of MerckKEYNOTE-564 ClinicalTrials.gov
NETL
NSTL
万方数据
维普
