Evidence map›Paper›PMID 40025394›Full record

Trial reportAdvances in therapy2025

First-Line Pembrolizumab Plus Chemotherapy for HER2-Negative Advanced Gastric Cancer: China Subgroup Analysis of the Randomized Phase 3 KEYNOTE-859 Study.

Shukui Qin, Yuxian Bai, Jin Li, Hongming Pan, Suxia Luo, Yanli Qu, Feng Ye, Lin Yang, Tianshu Liu, Wei Li and 11 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 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 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Article
  6. Article
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  8. Review
  9. 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

21 authors.

Shukui QinGI Cancer Center, Nanjing Tianyinshan Hospital of China Pharmaceutical University, No 3789, Jieyin Road, Jiangning District, Nanjing, 210000, Jiangsu, China. qinsk@csco.org.cn.
Yuxian BaiHarbin Medical University Cancer Hospital, Harbin, China.
Jin LiShanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Hongming PanZhejiang University School of Medicine, Sir Run Shaw Hospital, Hangzhou, China.
Suxia LuoThe Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital, Zhengzhou, China.
Yanli QuCancer Hospital Affiliated to Xinjiang Medical University, Xinjiang, China.
Feng YeThe First Affiliated Hospital of Xiamen University, Xiamen, China.
Lin YangNational Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Tianshu LiuZhongshan Hospital Affiliated to Fudan University, Shanghai, China.
Wei LiThe First Hospital of Jilin University, Changchun, China.
Xi ChenThe 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army, Fuzhou, China.
Jianwei YangFujian Provincial Cancer Hospital, Fuzhou, China.
Jieer YingZhejiang Cancer Hospital, Hangzhou, China.
Xiaoyan LinFujian Medical University Union Hospital, Fuzhou, China.
Lin ZhaoPeking Union Medical College Hospital, Beijing, China.
Xinjun LiangHubei Cancer Hospital, Wuhan, China.
Yixiang MaoMSD China, Shanghai, China.
Run GuoMSD China, Beijing, China.ORCID 0009-0001-3594-2642
Yi ZuoMSD China, Beijing, China.ORCID 0000-0002-6643-8326
Sonal BordiaMerck & Co., Inc., Rahway, NJ, USA.
Shouguo LiZhongshan Hospital Affiliated to Xiamen University, Xiamen, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionResults of the global, randomized, phase 3 KEYNOTE-859 study (N = 1579) showed that first-line pembrolizumab plus chemotherapy produced a statistically significant and clinically meaningful improvement in overall survival (OS) with manageable toxicity versus placebo plus chemotherapy in patients with locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction cancer. This subgroup analysis was conducted to investigate outcomes in patients enrolled in mainland China.

methodsAdults with previously untreated advanced or metastatic HER2-negative gastric cancer or gastroesophageal junction adenocarcinoma were randomly assigned (1:1) to receive pembrolizumab or placebo with fluoropyrimidine- and platinum-containing chemotherapy. The primary outcome was OS. Secondary outcomes included progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR), all assessed per RECIST v1.1 by blinded independent central review, and safety.

resultsOverall, 236 patients were enrolled in mainland China (126 pembrolizumab plus chemotherapy; 110 placebo plus chemotherapy). Median time from randomization to database cutoff (October 3, 2022) was 24.7 months (range 15.3-38.9). Median OS was 15.9 months (95% confidence interval [CI] 13.2-19.2) for pembrolizumab plus chemotherapy versus 12.2 months (95% CI 10.6-14.1) for placebo plus chemotherapy (hazard ratio [HR], 0.68; 95% CI 0.50-0.91). Median PFS was 8.1 months (95% CI 6.9-9.6) for pembrolizumab plus chemotherapy versus 5.7 months (95% CI 4.5-6.5) for placebo plus chemotherapy (HR, 0.65; 95% CI 0.48-0.88). ORR was 69.0% for pembrolizumab plus chemotherapy versus 45.5% for placebo plus chemotherapy; median DOR was 8.2 months (range 1.2+ to 34.6+) versus 5.5 months (range 1.3+ to 31.2+), respectively. Grade 3-5 treatment-related adverse events occurred in 82 patients (65.6%) treated with pembrolizumab plus chemotherapy and 54 patients (49.1%) treated with placebo plus chemotherapy.

conclusionConsistent with efficacy in the overall population from KEYNOTE-859, first-line pembrolizumab plus chemotherapy showed improved efficacy, versus placebo plus chemotherapy, and manageable safety in patients enrolled in mainland China.

trial registrationClinicaltrials.gov: NCT03675737.

Indexed as

AdenocarcinomaAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsStomach NeoplasmsAdultAgedChinaErb-b2 Receptor Tyrosine KinasesEsophagogastric JunctionFemaleHumansMaleMiddle AgedProgression-Free SurvivalAntibodies, Monoclonal, HumanizedERBB2 protein, humanErb-b2 Receptor Tyrosine KinasespembrolizumabChinaGastric adenocarcinomaGastroesophageal junction adenocarcinomaHER2-negativePembrolizumab

Identifiers

PMID40025394
PMCPMC11929688

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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.