Pembrolizumab (pembro) + chemotherapy (chemo) for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer: Updated results from the KEYNOTE-859 study.

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, Lina Yin, Sonal Bordia, Pooja Bhagia, Shukui Qin · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.2024.42.16_suppl.4045 · 被引用次数：10 · 研究领域：Gastric Cancer Management and Outcomes、Cancer Immunotherapy and Biomarkers、Esophageal Cancer Research and Treatment

4045 Background: At the protocol-specified interim analysis of the KEYNOTE-859 study (NCT03675737), first-line pembro + chemo significantly improved OS (HR, 0.78; 95% CI, 0.70-0.87; P<0.0001), PFS (HR, 0.76; 95% CI, 0.67-0.85; P<0.0001), and ORR (51.3% vs 42.0%; P=0.00009) vs placebo (pbo) + chemo in patients (pts) with HER2-negative G/GEJ cancer. We report results after an additional 11 months of follow-up. Methods: Pts with previously untreated locally advanced or metastatic HER2-negative G/GEJ cancer, measurable disease per RECIST v1.1, ECOG PS 0 or 1, and known PD-L1 combined positive score (CPS) were eligible. Pts were randomly assigned 1:1 to receive pembro 200 mg or pbo 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 August 22, 2023. Results: The intention-to-treat (ITT) population comprised 1579 pts (pembro + chemo, n=790; pbo + chemo, n=789). Median follow-up from randomization to data cutoff was 41.6 mo (range, 33.6-48.9). In the ITT population, 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 pbo + chemo (HR, 0.79; 95% CI, 0.71-0.88), median PFS was 6.9 mo (95% CI, 6.3-7.2) vs 5.6 mo (95% CI, 5.5-5.7; HR, 0.76 [95% CI, 0.68-0.85]), ORR was 51.0% vs 42.0%, and median DOR was 8.0 mo (range, 1.2+ to 52.6+) vs ...