Adjuvant Pembrolizumab Versus Placebo for Renal Cell Carcinoma in the East Asian Subgroup of the Phase 3 KEYNOTE-564 Study
- Author:
Se Hoon PARK
1
;
Yen-Hwa CHANG
;
Jae Lyun LEE
;
Toni K. CHOUEIRI
;
Go KIMURA
;
Jinsoo CHUNG
;
Naoya MASUMORI
;
Kazuo NISHIMURA
;
Minoru KATO
;
Haruaki KATO
;
Kazuyuki NUMAKURA
;
Chao-Hsiang CHANG
;
Satoshi ANAI
;
Hiroyuki TSUNEMORI
;
Chung-Hsin CHEN
;
Jianxin LIN
;
Aymen ELFIKY
;
Joseph E. BURGENTS
;
Hiroshi KITAMURA
Author Information
- Publication Type:Original Article
- From:Cancer Research and Treatment 2026;58(2):613-621
- CountryRepublic of Korea
- Language:English
-
Abstract:
Purpose:Adjuvant pembrolizumab improved disease-free survival (DFS) and overall survival (OS) versus placebo in participants with renal cell carcinoma (RCC) at increased risk of recurrence after nephrectomy in the global phase 3 KEYNOTE-564 study. This post hoc subgroup analysis evaluated the efficacy and safety of adjuvant pembrolizumab in East Asian (Japan, South Korea, and Taiwan) participants enrolled in KEYNOTE-564.
Materials and Methods:Eligible participants were randomly assigned 1:1 to receive adjuvant pembrolizumab 200 mg or placebo intravenously every 3 weeks for ≤ 17 cycles. The primary endpoint was DFS by investigator assessment. OS was a key secondary endpoint. Safety was a secondary endpoint.
Results:The East Asian subgroup included 126 participants (pembrolizumab, n=58; placebo, n=68). Median follow-up was 62.1 months (range, 49.6 to 73.0 months). Hazard ratio for DFS with pembrolizumab versus placebo was 0.70 (95% confidence interval 0.41 to 1.20). Median DFS was not reached with pembrolizumab versus 58.8 months with placebo; estimated 48-month rate was 61.3% versus 51.2%. Hazard ratio for OS was 0.47 (95% confidence interval, 0.15 to 1.49). Median OS was not reached with pembrolizumab and placebo; estimated 48-month rate was 94.8% versus 91.2%. Treatment-related adverse events occurred in 70.7% of participants (29.3% grade 3 or 4) receiving pembrolizumab and 36.8% of participants (0.0% grade 3 or 4) receiving placebo. No pembrolizumab-related deaths occurred.
Conclusion:In the KEYNOTE-564 East Asian subgroup, adjuvant pembrolizumab provided DFS and OS benefits versus placebo and had a safety profile consistent with the global results. These results further support pembrolizumab as adjuvant treatment for East Asian patients with RCC at increased risk of recurrence after nephrectomy.
