Overall Survival with Adjuvant Pembrolizumab in Renal-Cell Carcinoma.
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Choueiri Toni K, Tomczak Piotr, Park Se Hoon, Venugopal Balaji, Ferguson Tom, Symeonides Stefan N, Hajek Jaroslav, Chang Yen-Hwa, Lee Jae-Lyun, Sarwar Naveed, Haas Naomi B, Gurney Howard, Sawrycki Piotr, Mahave Mauricio, Gross-Goupil Marine, Zhang Tian, Burke John M, Doshi Gurjyot, Melichar Bohuslav, Kopyltsov Evgeniy, Alva Ajjai, Oudard Stephane, Topart Delphine, Hammers Hans, Kitamura Hiroshi, McDermott David F, Silva Adriano, Winquist Eric, Cornell Jerry, Elfiky Aymen, Burgents Joseph E, Perini Rodolfo F, Powles Thomas, KEYNOTE-564 Investigators
Аннотация
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. (Funded by Merck Sharp and Dohme, a subsidiary of Merck; KEYNOTE-564 ClinicalTrials.gov number, NCT03142334.).