{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T13:55:30Z","timestamp":1791813330224,"version":"4.3.4"},"reference-count":26,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T00:00:00Z","timestamp":1778112000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T00:00:00Z","timestamp":1778112000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100004948","name":"Astellas Pharma, Inc.","doi-asserted-by":"crossref","award":["Astellas Pharma, Inc."],"award-info":[{"award-number":["Astellas Pharma, Inc."]}],"id":[{"id":"10.13039\/501100004948","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Gastric Cancer"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Zolbetuximab is a monoclonal antibody targeting claudin 18 isoform 2 (CLDN18.2) approved for first-line treatment of CLDN18.2-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Here, we report efficacy and safety outcomes from the combined Japanese subgroup analysis of SPOTLIGHT and GLOW.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Global, double-blind, phase 3 SPOTLIGHT (NCT03504397) and GLOW (NCT03653507) trials investigated zolbetuximab plus chemotherapy versus placebo plus chemotherapy in patients with CLDN18.2-positive, HER2-negative, LA unresectable or metastatic gastric or GEJ adenocarcinoma. The primary endpoint in both trials was progression-free survival (PFS); overall survival (OS) was a key secondary endpoint.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 1072 patients enrolled, 116 Japanese patients (SPOTLIGHT, n\u2009=\u200965; GLOW, n\u2009=\u200951) comprised the combined Japanese subgroup. The baseline characteristics of Japanese patients were generally similar to those of the overall study populations. In the combined Japanese subgroup, PFS was improved with zolbetuximab plus chemotherapy versus placebo plus chemotherapy (20.53\u00a0months [95% confidence interval (CI) 12.09\u2013not estimable] versus 8.28\u00a0months [95% CI 6.57\u20139.07]). Median OS was 23.06\u00a0months (95% CI 16.49\u201325.49) in the zolbetuximab group versus 16.53\u00a0months (95% CI 10.38\u201318.33) in the placebo group. No new safety signals were observed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In Japanese patients, zolbetuximab plus chemotherapy improved PFS versus placebo plus chemotherapy and showed a numerical improvement in OS. These results support zolbetuximab plus chemotherapy as a potential new standard-of-care first-line option for Japanese patients with CLDN18.2-positive, HER2-negative, LA unresectable or metastatic gastric or GEJ adenocarcinoma.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s10120-026-01738-7","type":"journal-article","created":{"date-parts":[[2026,5,7]],"date-time":"2026-05-07T11:26:08Z","timestamp":1778153168000},"page":"777-787","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Zolbetuximab plus chemotherapy in Japanese patients with claudin 18.2\u2013positive gastric or gastroesophageal junction adenocarcinoma: a combined subgroup analysis of the phase 3 SPOTLIGHT and GLOW trials"],"prefix":"10.1007","volume":"29","author":[{"given":"Kensei","family":"Yamaguchi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirokazu","family":"Shoji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisateru","family":"Yasui","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eiji","family":"Oki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Sakai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tetsuya","family":"Hamaguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akihito","family":"Tsuji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Oshima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Tsuda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiko","family":"Minashi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianning","family":"Yang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abraham","family":"Guerrero","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoko","family":"Ueno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Matsangou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Georgia","family":"Gourgioti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuka","family":"Nakanishi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satomi","family":"Furuki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kana","family":"Kuwamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shunsuke","family":"Yamada","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5196-3630","authenticated-orcid":false,"given":"Kohei","family":"Shitara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,5,7]]},"reference":[{"key":"1738_CR1","first-page":"229","volume":"74","author":"F Bray","year":"2024","unstructured":"Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. 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Management of nausea and vomiting (N\/V) following first-line (1L) zolbetuximab+chemotherapy treatment in claudin-18.2 (CLDN18.2)+, HER2\u2212, locally advanced (LA) unresectable or metastatic gastric or gastroesophageal junction (mG\/GEJ) adenocarcinoma: analysis from the phase 3 SPOTLIGHT and GLOW studies. J Clin Oncol. 2024;42(3suppl):372.","DOI":"10.1200\/JCO.2024.42.3_suppl.372"},{"key":"1738_CR23","unstructured":"Boku N, Aogi K, Japan Society of Clinical Oncology. Anti-emetic therapy during first-line chemotherapy containing zolbetuximab for HER2-negative, Claudin 18.2-positive unresectable advanced\/recurrent gastric cancer. Flash report of the clinical practice guidelines for antiemesis. 2025. https:\/\/www.jsco.or.jp\/Portals\/0\/5_Guideline\/Flash%20report%20of%20the%20CPG%20for%20antiemesis_2025Feb%20(002).pdf. Accessed 13 Feb 2026."},{"key":"1738_CR24","doi-asserted-by":"crossref","unstructured":"Japanese Gastric Cancer Association. 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Hirokazu Shoji reports other financial\/nonfinancial interests with AbbVie, Astellas, AstraZeneca, Chugai, Daiichi Sankyo, Elevation Oncology, Merck Sharp & Dohme, Metagen, Ono, and Taiho. Hisateru Yasui has no conflicts to disclose. Eiji Oki has received honoraria from Astellas. Daisuke Sakai has received research funding from Astellas, Eisai, Lucyte, and Taiho. Tetsuya Hamaguchi has received grants from Astellas, AstraZeneca, BeiGene, Bristol Myers Squibb, Daiichi Sankyo, Eisai, Incyte Japan, Ono, and Pfizer and honoraria for lectures from Bayer, Bristol Myers Squibb Japan, Chugai, Daiichi Sankyo, Lilly, Merck Serono, Ono, Taiho, and Takeda. Akihito Tsuji has received payment or honoraria from Asahi Kasei Pharma, Astellas, AstraZeneca K.K., Bayer Yakuhin, Bristol-Myers Squibb K.K., Chugai, Daiichi Sankyo, Eisai, Eli Lilly Japan K.K., Guardant Health Japan K.K., Merck Biopharma, Merck Sharp & Dohme K.K., Nippon Zoki, Novartis Pharma K.K., Ono, Pfizer Japan, Sawai, Servier Japan, Shanghai Henlius Biotech, Sun Pharma, Taiho, Takata, Takeda, Terumo, Tsumura & Co., Yakult Honsha, and Zeria Pharmaceutical and reports participation on a data safety monitoring board or advisory board for FeliMedix Co and Shanghai Henlius Biotech. Takashi Oshima has no conflicts to disclose. Masahiro Tsuda has no conflicts to disclose. Keiko Minashi has received research funding (all to institution) from Astellas, BeiGene, Daiichi Sankyo, Merck Sharp & Dohme, Ono, and Taiho. Jianning Yang is an employee of Astellas. Abraham Guerrero is an employee of Astellas. Yoko Ueno is an employee of Astellas and owns stock or stock options in the company. Maria Matsangou is an employee of Astellas. Georgia Gourgioti is an employee of Astellas. Yuka Nakanishi is an employee of Astellas. Satomi Furuki is an employee of Astellas. Kana Kuwamoto is an employee of Astellas. Shunsuke Yamada is an employee of Astellas and owns stock in the company. Kohei Shitara reports advisory roles for ALX Oncology Inc., Amgen, Arcus Biosciences, Inc., Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, GlaxoSmithKline K.K., Guardant Health Japan, Healios K.K., Janssen, Merck Sharp & Dohme, Moderna, Novartis, Ono, Takeda, and Zymeworks; honoraria received from Astellas, AstraZeneca, Bristol Myers Squibb, Eli Lilly, Janssen, and Ono; and research funding (all to institution) from Amgen, Astellas, AstraZeneca, Chugai, Daiichi Sankyo, Eisai, Merck Sharp & Dohme, Ono, PPD-SNBL K.K., PRA Health Sciences, Syneos Health, Taiho, and Toray.","order":1,"name":"Ethics","label":"Conflict of interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964 and later versions. Informed consent to be included in the study, or the equivalent, was obtained from all patients.","order":2,"name":"Ethics","label":"Ethical approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}