Evidence map›Paper›PMID 40750941›Full record

Trial reportInternational journal of clinical oncology2025

First-line pembrolizumab plus chemotherapy for participants in Japan with gastric or gastroesophageal junction adenocarcinoma: subgroup analysis of the phase 3 KEYNOTE-859 study.

Hisateru Yasui, Masaki Aizawa, Kensei Yamaguchi, Akihito Kawazoe, Hiroki Hara, Masahiro Tsuda, Hirokazu Shoji, Naotoshi Sugimoto, Nobuhiro Shibata, Kenji Amagai and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03675737 (A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT03675737 phase3completednot on this map

A Phase 3, Randomized, Double-blind Clinical Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy as First-line Treatment in Participants With HER2 Negative, Previously Untreated, Unresectable or Metastatic Gastric Orgastroesophageal Junction Adenocarcinoma (KEYNOTE-859)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2018 to 2025Enrolled1,579ConditionsStomach NeoplasmsArmsPembrolizumab, Cisplatin, 5-fluorouracil, oxaliplatin, capecitabine
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Review
  2. Article
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

18 authors.

Hisateru YasuiKobe City Medical Center General Hospital, Kobe, Japan.
Masaki AizawaNiigata Cancer Center Hospital, Niigata, Japan.
Kensei YamaguchiThe Cancer Institute Hospital of Japanese Foundation for Cancer, Tokyo, Japan.
Akihito KawazoeNational Cancer Center Hospital East, Kashiwa, Japan.
Hiroki HaraSaitama Cancer Center, Saitama, Japan.
Masahiro TsudaHyogo Cancer Center, Akashi, Japan.
Hirokazu ShojiNational Cancer Center Hospital, Tokyo, Japan.
Naotoshi SugimotoOsaka International Cancer Institute, Osaka, Japan.
Nobuhiro ShibataKansai Medical University Hospital, Hirakata, Japan.
Kenji AmagaiIbaraki Prefectural Central Hospital, Kasama, Japan.
Yasuhiro ChodaHiroshima City Hiroshima Citizens Hospital, Hiroshima, Japan.
Shiro IwagamiGraduate School of Medical Sciences, Kumamoto University, Kumamoto, Japan.
Taito EsakiNational Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Shigenori KadowakiAichi Cancer Center Hospital, Nagoya, Japan.
Shinichi ShiratoriMSD K.K., Tokyo, Japan.
Shirong HanMSD K.K., Tokyo, Japan.
Sonal BordiaMerck & Co., Inc., Rahway, NJ, USA.
Kohei ShitaraNational Cancer Center Hospital East, Kashiwa, Japan. kshitara@east.ncc.go.jp.ORCID http://orcid.org/0000-0001-5196-3630

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn 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.

methodsParticipants 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.

resultsOverall, 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.

conclusionsConsistent 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 registrationClinicalTrials.gov, NCT03675737.

Indexed as

AdenocarcinomaAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsEsophagogastric JunctionStomach NeoplasmsAdultAgedAged, 80 and overFemaleHumansJapanMaleMiddle AgedProgression-Free SurvivalAntibodies, Monoclonal, HumanizedpembrolizumabAdenocarcinomaGastric cancerGastroesophageal junction cancerJapanPembrolizumab

Identifiers

PMID40750941

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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.