KEYNOTE-859 study of pembrolizumab plus chemotherapy for advanced HER2-negative gastric or gastroesophageal junction (G/GEJ) cancer: Outcomes in the protocol-specified PD-L1–selected populations.

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 Melo Cruz, Shukui Qin, Lina Yin, Sonal Bordia, Pooja Bhagia, Do‐Youn Oh · 发表于：Journal of Clinical Oncology · 年份：2023 · DOI：10.1200/jco.2023.41.16_suppl.4014 · 被引用次数：12 · 研究领域：Gastric Cancer Management and Outcomes、Esophageal Cancer Research and Treatment、Colorectal Cancer Treatments and Studies

4014 Background: In the ITT population of the KEYNOTE-859 study of HER2-negative, advanced G/GEJ cancer (NCT03675737), pembrolizumab (pembro) + chemotherapy (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 + chemo at the protocol-specified interim analysis. The safety profile of pembro + chemo was as expected. We present efficacy outcomes of the protocol-specified PD-L1 combined positive score (CPS) ≥1 and CPS ≥10 populations. Methods: Eligible pts aged ≥18 y with HER2-negative, previously untreated locally advanced or metastatic G/GEJ adenocarcinoma, ECOG PS 0-1, and known PD-L1 CPS were randomized 1:1 to pembro 200 mg or placebo IV Q3W for ≤35 cycles, both given with investigator’s choice of 5-FU + cisplatin (FP) or capecitabine + oxaliplatin (CAPOX). Randomization was stratified by region (Europe/Israel/North America/Australia vs Asia vs rest of world), PD-L1 CPS (<1 vs ≥1), and chemo (FP vs CAPOX). Per protocol, the primary endpoint of OS and the secondary endpoints of PFS and ORR per RECIST v1.1 by blinded independent central review were tested in the PD-L1 CPS ≥1 and ≥10 populations. Data are from the interim analysis (median study follow-up, 31.0 mo). Results: At baseline, 618 (78.2%) of 790 pts randomized to pembro + chemo and 617 (78.2%) of 789 pts randomized to placebo + chemo had PD-L1 CPS ≥1; 279 (35.3%) and 272 (34.5%), respectively, ha...