Five-year follow-up results from the phase 3 KEYNOTE-564 study of adjuvant pembrolizumab (pembro) for the treatment of clear cell renal cell carcinoma (ccRCC).

作者：Naomi B. Haas, Thomas Powles, Piotr Tomczak, Se Hoon Park, Balaji Venugopal, Stefan N. Symeonides, Tom Ferguson, Wayne Yen Hwa Chang, Jae‐Lyun Lee, Piotr Sawrycki, Naveed Sarwar, Howard Gurney, Marine Gross‐Goupil, John M. Burke, Gury K. Doshi, Jerry Cornell, Joseph E. Burgents, Rodolfo F. Perini, Toni K. Choueiri · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.4514 · 被引用次数：5 · 研究领域：Renal cell carcinoma treatment、Cancer Immunotherapy and Biomarkers、Renal and related cancers

4514 Background: KEYNOTE-564 (NCT03142334) established pembro monotherapy as the first adjuvant regimen to significantly improve both disease-free survival (DFS) and overall survival (OS) vs placebo (pbo) after surgery for participants (pts) with ccRCC at increased risk of recurrence. We present results from the fourth prespecified interim analysis with a minimum follow-up of 5 yrs. Methods: KEYNOTE-564 is a randomized, double-blind, pbo-controlled, phase 3 study, which enrolled adults with ccRCC with intermediate-high (pT2 Gr 4 or sarcomatoid, or pT3 any Gr, N0 M0) or high (pT4 any Gr, N0 M0, or any pT and Gr, N+ M0) risk of recurrence or M1 with no evidence of disease (NED) who had nephrectomy and/or metastasectomy ≤12 wks prior to 1:1 randomization to pembro 200 mg or pbo IV Q3W. Treatment continued for ~1 yr (17 cycles) or until recurrence, intolerable AEs, or physician decision to discontinue treatment. The primary endpoint was DFS by investigator; the key secondary endpoint was OS. The study met its DFS and OS objectives at earlier analyses; thus, no subsequent formal statistical testing occurred. AEs were collected for 30-90 days after treatment cessation depending on severity, with serious treatment-related AEs collected regardless of timing. Results: A total of 994 pts were randomized to pembro (n = 496) or pbo (n = 498). The median follow-up time to data cutoff date of 25 Sept 2024 was 69.5 mo (range, 60.2−86.9). All pts completed or discontinued study treatment ≥3 ...