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	ONO-4578 Plus Nivolumab in Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer.
掲載誌名	正式名：Cancer science 略　 称：Cancer Sci ISSNコード：13497006/13479032
掲載区分	国外
巻・号・頁	116(9),pp.2523-2536
著者・共著者	Akihito Kawazoe, Kensei Yamaguchi, Tetsuya Hamaguchi, Yukiya Narita, Shogen Boku, Takashi Oshima, Hiroki Hara, Yasuo Hamamoto, Kenji Ishido, Taito Esaki, Hisashi Hosaka, Hirofumi Yasui, Keisuke Koeda, Tomohiro Nishina, Yasushi Tsuji, Takeo Fukagawa, Masahiro Goto, Eiji Oki, Naotoshi Sugimoto, Hiroshi Matsuoka, Fumiharu Yokoyama, Tomoko Yoshida, Kazuo Yoshida, Yoshiaki Oshima, Satoru Iwasa
発行年月	2025/09
概要	ONO-4578, an EP4 antagonist, alone and combined with nivolumab, showed acceptable safety profiles and signs of antitumor activity in solid tumors. The expansion part examined the safety, preliminary efficacy, and biomarkers of ONO-4578 plus nivolumab in unresectable advanced or recurrent gastric or gastroesophageal junction (G/GEJ) cancer. Patients were enrolled into three groups: with previous immuno-oncology treatment (IO-treated; n = 30), without IO treatment (IO-naive; n = 30), and with UGT1A1 polymorphism (UGT1A1p; n = 6). Treatment-related adverse events (TRAEs) occurred in 46 patients (grade 3-4 in 17), with no grade 5 events reported. We confirmed the tolerability of the treatment in UGT1A1p. Objective response and disease control rates were 10.0% and 73.3%, respectively, in IO-treated and 16.7% and 40.0%, respectively, in IO-naive. Biomarker analysis indicated immune activation in the tumor microenvironment after the treatment. In conclusion, ONO-4578 plus nivolumab showed a manageable safety profile and antitumor activity in G/GEJ cancer. Trial Registration: Japan Registry of Clinical Trials number: jRCT2080223441; ClinicalTrials.gov identifier: NCT03155061.
DOI	10.1111/cas.70130
PMID	40618725