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Original Article
- Adjuvant Pembrolizumab Versus Placebo for Renal Cell Carcinoma in the East Asian Subgroup of the Phase 3 KEYNOTE-564 Study
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Se Hoon Park1
, Yen-Hwa Chang2, Jae Lyun Lee3, Toni K. Choueiri4, Go Kimura5, Jinsoo Chung6, Naoya Masumori7, Kazuo Nishimura8, Minoru Kato9, Haruaki Kato10, Kazuyuki Numakura11, Chao-Hsiang Chang12, Satoshi Anai13,14, Hiroyuki Tsunemori15,16, Chung-Hsin Chen17, Jianxin Lin18, Aymen Elfiky18, Joseph E. Burgents18, Hiroshi Kitamura19 -
DOI: https://doi.org/10.4143/crt.2025.365 [Accepted]
Published online: June 26, 2025
1Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
2Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan
3Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
4Department of Medical Oncology, Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, Boston, MA, USA
5Department of Urology, Nippon Medical School Hospital, Tokyo, Japan
6Department of Urology, National Cancer Center, Goyang, Korea
7Department of Urology, Sapporo Medical University Hospital, Sapporo, Japan
8Department of Urology, Osaka International Cancer Institute, Osaka, Japan
9Department of Urology, Osaka Metropolitan University Hospital, Osaka, Japan
10Department of Urology, Nagano Municipal Hospital, Nagano, Japan
11Department of Urology, Akita University Graduate School of Medicine, Akita, Japan
12Department of Urology, China Medical University Hospital, Taichung, Taiwan
13Nara Prefecture Seiwa Medical Center, Nara, Japan
14Department of Urology, Nara Medical University, Nara, Japan
15Takinomiya General Hospital, Ayagawa, Japan
16Department of Urology, Kagawa University Hospital, Miki, Japan
17Department of Urology, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan
18Merck & Co., Inc., Rahway, NJ, USA
19Department of Urology, University of Toyama, Toyama, Japan
2Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan
3Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea
4Department of Medical Oncology, Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, Boston, MA, USA
5Department of Urology, Nippon Medical School Hospital, Tokyo, Japan
6Department of Urology, National Cancer Center, Goyang, Korea
7Department of Urology, Sapporo Medical University Hospital, Sapporo, Japan
8Department of Urology, Osaka International Cancer Institute, Osaka, Japan
9Department of Urology, Osaka Metropolitan University Hospital, Osaka, Japan
10Department of Urology, Nagano Municipal Hospital, Nagano, Japan
11Department of Urology, Akita University Graduate School of Medicine, Akita, Japan
12Department of Urology, China Medical University Hospital, Taichung, Taiwan
13Nara Prefecture Seiwa Medical Center, Nara, Japan
14Department of Urology, Nara Medical University, Nara, Japan
15Takinomiya General Hospital, Ayagawa, Japan
16Department of Urology, Kagawa University Hospital, Miki, Japan
17Department of Urology, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan
18Merck & Co., Inc., Rahway, NJ, USA
19Department of Urology, University of Toyama, Toyama, Japan
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Corresponding author:
Se Hoon Park
Tel: 82 2 3410 1767
Email: hematoma@skku.edu
Received: 29 March 2025 • Accepted: 25 June 2025
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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, 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 49.6‒73.0). Hazard ratio for DFS with pembrolizumab versus placebo was 0.70 (95% confidence interval 0.41‒1.20). 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 0.15‒1.49). 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 3‒4) receiving pembrolizumab and 36.8% of participants (0.0% grade 3‒4) 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.
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