KEYNOTE-859: 4.5-year median follow-up of pembrolizumab plus chemotherapy for previously untreated advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

作者：Sun Young Rha, Lucjan Wyrwicz, P.E. Yanez Weber, Yuxian Bai, Min‐Hee Ryu, Jeeyun Lee, Fernando Rivera, Gustavo Vasconcelos Alves, Marcelo Garrido, Kai‐Keen Shiu, M. Fernández, Jin Li, Maeve A. Lowery, Timuçin Çil, Felipe José Silva Melo Cruz, Do‐Youn Oh, P. Leconte, Pooja Bhagia, Shukui Qin · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.4036 · 被引用次数：3 · 研究领域：Gastric Cancer Management and Outcomes、Gastrointestinal Tumor Research and Treatment、Cancer Immunotherapy and Biomarkers

4036 Background: In the phase 3KEYNOTE-859 study (NCT03675737), first-linepembrolizumab (pembro) + chemotherapy (chemo) continued to provide longer OS (HR, 0.79; 95% CI, 0.71-0.88) and PFS (HR, 0.76; 95% CI, 0.68-0.85), and a higher ORR (51.0% vs 42.0%) vs placebo + chemo in participants (pts) with HER2-negative G/GEJ adenocarcinoma, after a median follow-up of 41.6 mo (August 22, 2023). We present results after an additional 13 mo of follow-up. Methods: Eligible pts with untreated locally advanced or metastatic HER2-negative G/GEJ adenocarcinoma with PD-L1 status, measurable disease, and ECOG PS 0 or 1 were randomly assigned 1:1 to receive pembro 200 mg or placebo IV Q3W for ≤35 cycles + investigator’s choice of chemo (5-FU + cisplatin [FP] vs capecitabine + oxaliplatin [CAPOX]). The primary end point was OS. Secondary end points included PFS, ORR, and DOR, all per RECIST v1.1 by BICR, and safety. The data cutoff was September 27, 2024. Results: Median follow-up was 54.8 mo (Q1-Q3, 46.8-62.1). In all randomly assigned pts in the intention-to-treat population (N = 1579), median OS was 12.9 mo (95% CI, 11.9-14.0) for pembro + chemo vs 11.5 mo (95% CI, 10.6-12.1) for placebo + chemo (HR, 0.78; 95% CI, 0.70-0.86). In pts with PD-L1 CPS ≥1, median OS was 13.0 mo (95% CI, 11.6-14.2) vs 11.4 mo (95% CI, 10.5-12.0; HR, 0.74 [95% CI, 0.66-0.84]). In pts with PD-L1 CPS ≥10, median OS was 15.8 mo (95% CI, 14.0-19.3) vs 11.8 mo (95% CI, 10.3-12.7; HR, 0.64 [95% CI, 0.53-0.77]). PFS, ORR...