論文種別	原著(症例報告除く)
言語種別	英語
査読の有無	その他(不明)
表題	First-line pembrolizumab plus chemotherapy for participants in Japan with gastric or gastroesophageal junction adenocarcinoma: subgroup analysis of the phase 3 KEYNOTE-859 study.
掲載誌名	正式名：International journal of clinical oncology 略　 称：Int J Clin Oncol ISSNコード：14377772/13419625
掲載区分	国外
巻・号・頁	30(10),pp.2003-2011
著者・共著者	Hisateru Yasui, Masaki Aizawa, Kensei Yamaguchi, Akihito Kawazoe, Hiroki Hara, Masahiro Tsuda, Hirokazu Shoji, Naotoshi Sugimoto, Nobuhiro Shibata, Kenji Amagai, Yasuhiro Choda, Shiro Iwagami, Taito Esaki, Shigenori Kadowaki, Shinichi Shiratori, Shirong Han, Sonal Bordia, Kohei Shitara
発行年月	2025/10
概要	BACKGROUND:In the global phase 3 KEYNOTE-859 study (NCT03675737), first-line pembrolizumab plus chemotherapy significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) versus placebo plus chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. This post hoc analysis of KEYNOTE-859 evaluated outcomes in participants enrolled in Japan.METHODS:Participants with untreated locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma were randomly assigned to receive pembrolizumab 200 mg or placebo intravenously every 3 weeks for ≤ 35 cycles plus investigator's choice of chemotherapy. The primary end point was OS. Secondary end points were ORR, DOR, and PFS per RECIST v1.1, by blinded independent central review, and safety. Data cutoff was October 3, 2022.RESULTS:Overall, 101 participants were enrolled in Japan (n = 48 pembrolizumab plus chemotherapy [pembrolizumab group]; n = 53 placebo plus chemotherapy [placebo group]). Median follow-up was 28.9 months (range, 22.0-42.0). Median OS was 16.8 months with pembrolizumab versus 13.3 months with placebo (hazard ratio [HR], 0.71; 95% CI, 0.44-1.13). Grade 3 or 4 treatment-related adverse events occurred in 41.7% of participants given pembrolizumab and 39.6% of participants given placebo; none were grade 5.CONCLUSIONS:Consistent with the global KEYNOTE-859 results, OS was better with pembrolizumab plus chemotherapy, with manageable safety, for participants enrolled in Japan. Results continue to support pembrolizumab plus chemotherapy as a new first-line treatment option for patients with advanced or metastatic HER2-negative gastric or GEJ adenocarcinoma.TRIAL REGISTRATION:ClinicalTrials.gov, NCT03675737.
DOI	10.1007/s10147-025-02847-6
PMID	40750941