Evidence map›Paper›PMID 38242717›Full record

ArticleJournal for immunotherapy of cancer2024

Evaluation of potential biomarkers for lenvatinib plus pembrolizumab among patients with advanced endometrial cancer: results from Study 111/KEYNOTE-146.

Vicky Makker, Matthew H Taylor, Carol Aghajanian, Allen L Cohn, Marcia S Brose, Christopher Di Simone, Zhu Alexander Cao, Leah Suttner, Andrey Loboda, Razvan Cristescu and 7 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Journal for immunotherapy of cancer, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02501096 (A Multicenter, Open-Label Phase 1b/2 Trial of Lenvatinib), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
4.2field-weighted citation impact, top 5% of its field
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.

NCT02501096 phase1 / phase2completednot on this map

A Multicenter, Open-Label Phase 1b/2 Trial of Lenvatinib (E7080) Plus Pembrolizumab in Subjects With Selected Solid Tumors

TypeinterventionalSponsorEisai Inc.Ran2015 to 2022Enrolled357ConditionsTumorsArmsLenvatinib, Pembrolizumab
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 15 citations in OpenAlex.

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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

17 authors at 9 institutions in 2 countries.

Vicky MakkerMemorial Sloan Kettering Cancer Center, New York, New York, USA makkerv@mskcc.org.ORCID 0000-0001-9793-7614
Matthew H TaylorEarle A. Chiles Research Institute, Providence Cancer Institute, Portland, Oregon, USA.
Carol AghajanianMemorial Sloan Kettering Cancer Center, New York, New York, USA.
Allen L CohnRocky Mountain Cancer Center, Denver, Colorado, USA.
Marcia S BroseDepartment of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, USA.
Christopher Di SimoneArizona Oncology Associates, Tucson, Arizona, USA.
Zhu Alexander CaoMerck & Co., Inc, Rahway, New Jersey, USA.
Leah SuttnerMerck & Co., Inc, Rahway, New Jersey, USA.
Andrey LobodaMerck & Co., Inc, Rahway, New Jersey, USA.
Razvan CristescuMerck & Co., Inc, Rahway, New Jersey, USA.
Petar JelinicMerck & Co., Inc, Rahway, New Jersey, USA.
Robert OrlowskiMerck & Co., Inc, Rahway, New Jersey, USA.
Lea DuttaEisai Inc, Nutley, New Jersey, USA.
Junji MatsuiEisai Inc, Nutley, New Jersey, USA.
Corina E DutcusEisai Inc, Nutley, New Jersey, USA.
Yukinori MinoshimaEisai Co. Ltd, Tsukuba, Japan.
Mark J MessingTexas Oncology, Bedford, Texas, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USEisai (United States) · USMemorial Sloan Kettering Cancer Center · USArizona Oncology · USEisai (Japan) · JPProvidence Portland Medical Center · USRocky Mountain Cancer Centers · USTexas Oncology · USThomas Jefferson University Hospital · US

Funding

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

Abstract

backgroundLenvatinib plus pembrolizumab demonstrated clinically meaningful benefit in patients with previously treated advanced endometrial carcinoma in Study 111/KEYNOTE-146 (NCT02501096). In these exploratory analyses from this study, we evaluated the associations between clinical outcomes and gene expression signature scores and descriptively summarized response in biomarker subpopulations defined by tumor mutational burden (TMB) and DNA variants for individual genes of interest.

methodsPatients with histologically confirmed metastatic endometrial carcinoma received oral lenvatinib 20 mg once daily plus intravenous pembrolizumab 200 mg every 3 weeks for 35 cycles. Archived formalin-fixed paraffin-embedded tissue was obtained from all patients. T-cell-inflamed gene expression profile (Tcell

results93 and 79 patients were included in the RNA-sequencing-evaluable and WES-evaluable populations, respectively. No statistically significant associations were observed between any of the RNA-sequencing signature scores and objective response rate or progression-free survival. Area under the receiver operating characteristic curve values for response ranged from 0.39 to 0.54; all 95% CIs included 0.50. Responses were seen regardless of TMB (≥175 or <175 mutations/exome) and mutation status. There were no correlations between Tcell

conclusionsThis analysis demonstrated efficacy for lenvatinib plus pembrolizumab regardless of biomarker status. Results from this study do not support clinical utility of the evaluated biomarkers. Further investigation of biomarkers for this regimen is warranted. TRIAL REGISTRATION NUMBER: NCT02501096.

Indexed as

Antibodies, Monoclonal, HumanizedEndometrial NeoplasmsPhenylurea CompoundsQuinolinesBiomarkers, TumorFemaleHumansRNAAntibodies, Monoclonal, HumanizedBiomarkers, TumorlenvatinibpembrolizumabPhenylurea CompoundsQuinolinesRNAImmunotherapyTumor Biomarkers

Identifiers

PMID38242717
PMCPMC10806562
OpenAlexW4391042095

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.