Evidence map›Paper›PMID 42095986›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2026

Zolbetuximab plus chemotherapy in Japanese patients with claudin 18.2-positive gastric or gastroesophageal junction adenocarcinoma: a combined subgroup analysis of the phase 3 SPOTLIGHT and GLOW trials.

Kensei Yamaguchi, Hirokazu Shoji, Hisateru Yasui, Eiji Oki, Daisuke Sakai, Tetsuya Hamaguchi, Akihito Tsuji, Takashi Oshima, Masahiro Tsuda, Keiko Minashi and 10 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03504397 phase3active not recruitingnot on this map

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus mFOLFOX6 Compared With Placebo Plus mFOLFOX6 as First-line Treatment of Subjects With Claudin (CLDN)18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2018 to 2026Enrolled565ConditionsLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) AdenocarcinomaArmszolbetuximab, placebo, oxaliplatin, folinic acid, fluorouracil
NCT03653507 phase3active not recruitingnot on this map

A Phase 3, Global, Multi-Center, Double-Blind, Randomized, Efficacy Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-Positive, HER2-Negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

TypeinterventionalSponsorAstellas Pharma Global Development, Inc.Ran2018 to 2026Enrolled507ConditionsLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) AdenocarcinomaArmszolbetuximab, oxaliplatin, capecitabine, placebo
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Kensei YamaguchiCancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Hirokazu ShojiNational Cancer Center Hospital, Tokyo, Japan.
Hisateru YasuiKobe City Medical Center General Hospital, Hyogo, Japan.
Eiji OkiKyushu University, Fukuoka, Japan.
Daisuke SakaiOsaka University, Osaka, Japan.
Tetsuya HamaguchiSaitama Medical University International Medical Center, Saitama, Japan.
Akihito TsujiKagawa University, Kagawa, Japan.
Takashi OshimaKanagawa Cancer Center, Kanagawa, Japan.
Masahiro TsudaHyogo Cancer Center, Hyogo, Japan.
Keiko MinashiChiba Cancer Center, Chiba, Japan.
Jianning YangAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Abraham GuerreroAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Yoko UenoAstellas Pharma, Inc., Tokyo, Japan.
Maria MatsangouAstellas Pharma Global Development, Inc., Northbrook, IL, USA.
Georgia GourgiotiAstellas Pharma Europe Ltd., Addlestone, UK.
Yuka NakanishiAstellas Pharma, Inc., Tokyo, Japan.
Satomi FurukiAstellas Pharma, Inc., Tokyo, Japan.
Kana KuwamotoAstellas Pharma, Inc., Tokyo, Japan.
Shunsuke YamadaAstellas Pharma, Inc., Tokyo, Japan.
Kohei ShitaraDepartment of Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. kshitara@east.ncc.go.jp.ORCID http://orcid.org/0000-0001-5196-3630

Funding

Astellas Pharma, Inc. Astellas Pharma, Inc.
6 · The paper itself

Abstract

backgroundZolbetuximab 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.

methodsGlobal, 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.

resultsOf 1072 patients enrolled, 116 Japanese patients (SPOTLIGHT, n = 65; GLOW, n = 51) 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 months [95% confidence interval (CI) 12.09-not estimable] versus 8.28 months [95% CI 6.57-9.07]). Median OS was 23.06 months (95% CI 16.49-25.49) in the zolbetuximab group versus 16.53 months (95% CI 10.38-18.33) in the placebo group. No new safety signals were observed.

conclusionsIn 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.

Indexed as

AdenocarcinomaAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsClaudinsEsophageal NeoplasmsEsophagogastric JunctionStomach NeoplasmsAdultAgedAged, 80 and overAntibodies, MonoclonalDouble-Blind MethodEast Asian PeopleFemaleHumansJapanAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedClaudinsCLDN18 protein, humanzolbetuximabAdenocarcinomaClaudinsEsophagogastric junctionStomach neoplasmsZolbetuximab

Identifiers

PMID42095986
PMCPMC13314679

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.