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.
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.
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.
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.
Cancer research and treatment. 2025 Jun 26 [Epub ahead of print]
Se Hoon Park, 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
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea., Department of Urology, Taipei Veterans General Hospital, Taipei, Taiwan., Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea., Department of Medical Oncology, Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, Boston, MA, USA., Department of Urology, Nippon Medical School Hospital, Tokyo, Japan., Department of Urology, National Cancer Center, Goyang, Korea., Department of Urology, Sapporo Medical University Hospital, Sapporo, Japan., Department of Urology, Osaka International Cancer Institute, Osaka, Japan., Department of Urology, Osaka Metropolitan University Hospital, Osaka, Japan., Department of Urology, Nagano Municipal Hospital, Nagano, Japan., Department of Urology, Akita University Graduate School of Medicine, Akita, Japan., Department of Urology, China Medical University Hospital, Taichung, Taiwan., Nara Prefecture Seiwa Medical Center, Nara, Japan., Takinomiya General Hospital, Ayagawa, Japan., Department of Urology, National Taiwan University Hospital and College of Medicine, Taipei, Taiwan., Merck & Co., Inc., Rahway, NJ, USA., Department of Urology, University of Toyama, Toyama, Japan.