Evidence map›Paper›PMID 40632415›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2025

Q-TWiST analysis of first-line nivolumab plus chemotherapy versus chemotherapy in patients with advanced gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma from CheckMate 649: 4-year follow-up results.

Daniel Lin, Wenying Quan, Marne Garretson, Viktor Chirikov, Clara Chen, Prianka Singh, Catherine Davis, Ryan Sugarman

Registry-linked trialAbstract readRandomized 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, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02872116 (A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

NCT02872116 phase3completednot on this map

A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

TypeinterventionalSponsorBristol-Myers SquibbRan2016 to 2024Enrolled2,031ConditionsGastric Cancer, Gastroesophageal Junction Cancer, Esophageal AdenocarcinomaArmsNivolumab, Ipilimumab, Oxaliplatin, Capecitabine, Leucovorin
3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Review
  3. Review
  4. CLEVER-1Frontiers in immunology · 2026
    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

8 authors.

Daniel LinDepartment of Medical Oncology, Thomas Jefferson University Hospital, 1025 Walnut Street, Suite 700 College Building, Philadelphia, PA, 19107, USA. daniel.lin@jefferson.edu.ORCID 0000-0003-1352-8915
Wenying QuanOPEN Health, HEOR and Market Access, 1140 6 Ave., Floor 18, New York, NY, 10036, USA.
Marne GarretsonOPEN Health, HEOR and Market Access, 1140 6 Ave., Floor 18, New York, NY, 10036, USA.
Viktor ChirikovOPEN Health, HEOR and Market Access, 1140 6 Ave., Floor 18, New York, NY, 10036, USA.
Clara ChenBristol Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08543, USA.
Prianka SinghBristol Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08543, USA.
Catherine DavisBristol Myers Squibb, Route 206 and Province Line Road, Princeton, NJ, 08543, USA.
Ryan SugarmanMemorial Sloan Kettering Cancer Center, New York, NY, 10065, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundNivolumab plus chemotherapy demonstrated clinically significant improvement in quality-adjusted survival versus chemotherapy alone as first-line treatment for advanced non-HER2-positive gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC) in the CheckMate 649 post-hoc quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis at 1-year minimum follow-up. We report Q-TWiST analysis results at 4-year minimum follow-up.

methodsQ-TWiST methodology was applied post-hoc to CheckMate 649 study data from all randomized patients, patients with PD-L1 combined positive score (CPS) ≥ 1, and patients with PD-L1 CPS ≥ 5. Relative Q-TWiST gains ≥ 10% were predefined as clinically important and ≥ 15% as clearly clinically important.

resultsAmong all randomized patients, patients with PD-L1 CPS ≥ 1, and patients with PD-L1 CPS ≥ 5, mean (95% CI) absolute Q-TWiST gains of 3.4 (1.8-5.1), 4.2 (2.4-6.1), and 5.4 (3.0-7.7) months with nivolumab plus chemotherapy versus chemotherapy were observed, respectively. These translated to clearly clinically important relative Q-TWiST gains of 20.5%, 26.1%, and 33.4% in each population; relative Q-TWiST gains benefit remained clearly clinically important in all subgroups (15.7%, 20.3%, and 26.4%) after expanding the analysis to include grade 2 adverse events. Greater Q-TWiST gains were observed with nivolumab plus chemotherapy across most subgroups in all randomized patients and patients with PD-L1 CPS ≥ 1 and across all subgroups in patients with PD-L1 CPS ≥ 5.

conclusionClearly clinically important benefit in quality-adjusted survival with first-line nivolumab plus chemotherapy versus chemotherapy was observed across all evaluated PD-L1 CPS expression levels in patients with advanced GC/GEJC/EAC from CheckMate 649 with 4-year minimum follow-up.

trial registrationClinicalTrials.gov identifier, NCT02872116.

Indexed as

AdenocarcinomaAntineoplastic Combined Chemotherapy ProtocolsEsophageal NeoplasmsEsophagogastric JunctionNivolumabStomach NeoplasmsAdultAgedB7-H1 AntigenFemaleFollow-Up StudiesHumansMaleMiddle AgedSurvival RateB7-H1 AntigenCD274 protein, humanNivolumabEsophageal adenocarcinomaGastric cancerGastroesophageal junction cancerNivolumabQ-TWiST

Identifiers

PMID40632415
PMCPMC12378121

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.