Evidence map›Paper›PMID 34990208›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Pembrolizumab in Patients With Microsatellite Instability-High Advanced Endometrial Cancer: Results From the KEYNOTE-158 Study.

David M O'Malley, Giovanni Mendonca Bariani, Philippe A Cassier, Aurelien Marabelle, Aaron R Hansen, Ana De Jesus Acosta, Wilson H Miller, Tamar Safra, Antoine Italiano, Linda Mileshkin and 4 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. 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 293 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
293citing papers in PubMed, 10 pooled it
64.9field-weighted citation impact, top 1% 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.

NCT02628067 phase2active not recruitingnot on this map

A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2015 to 2027Enrolled1,609ConditionsAdvanced Cancer, Anal Carcinoma, Anal Cancer, Biliary CancerArmspembrolizumab
NCT05998798 not yet recruitingnot on this mapstarted 2024, after this paper: background citation

A Journey Endometrial Cancer Clinical Trials - Revealing Engagement Patterns Among Individuals Affected by Endometrial Cancer

TypeobservationalSponsorPower Life Sciences Inc.Ran2024 to 2026Enrolled500ConditionsEndometrial Cancer
3 · Its place in the literature

Who cites it

293 citing papers in PubMed, 10 syntheses or guidelines pooled it, 470 citations in OpenAlex.

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233 more citing papers are in PubMed but not listed here.

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

14 authors at 12 institutions in 7 countries.

David M O'MalleyDivision of Gynecologic Oncology, The Ohio State University Wexner Medical Center and The James Comprehensive Cancer Center, Columbus, OH.ORCID 0000-0002-2828-0177
Giovanni Mendonca BarianiDepartment of Medical Oncology, Instituto do Câncer do Estado de São Paulo, Universidade de São Paulo, São Paulo, Brazil.
Philippe A CassierDepartment of Medical Oncology, Centre Léon Bérard, Lyon, France.ORCID 0000-0003-3857-1688
Aurelien MarabelleDépartement d'Innovation Thérapeutique et d'Essais Précoces (DITEP), Institut National de la Santé et de la Recherche Médicale (INSERM U1015), Gustave Roussy, Université Paris Saclay, Villejuif, France.ORCID 0000-0002-5816-3019
Aaron R HansenDivision of Medical Oncology, Princess Margaret Cancer Centre, Toronto, ON, Canada.ORCID 0000-0002-2363-8707
Ana De Jesus AcostaSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD.
Wilson H MillerSegal Cancer Centre, Jewish General Hospital, Rossy Cancer Network, Montreal, QC, Canada.
Tamar SafraOncology Department, Tel Aviv Medical Center, Tel Aviv, Israel.ORCID 0000-0001-6910-6426
Antoine ItalianoEarly Phase Trials and Sarcoma Units, Institut Bergonie, Bordeaux, France.ORCID 0000-0002-8540-5351
Linda MileshkinPeter MacCallum Cancer Centre and the Sir Peter MacCallum Department of Oncology, The University of Melbourne, Melbourne, VIC, Australia.
Lei XuMerck & Co, Inc, Kenilworth, NJ.
Fan JinMerck & Co, Inc, Kenilworth, NJ.
Kevin NorwoodMerck & Co, Inc, Kenilworth, NJ.
Michele MaioDivision of Medical Oncology and Immunotherapy, Center for Immuno-Oncology, Department of Oncology, University Hospital of Siena, Siena, Italy.ORCID 0000-0002-0323-6321
Merck & Co., Inc., Rahway, NJ, USA (United States) · USCentre Léon Bérard · FRInserm · FRJewish General Hospital · CAPrincess Margaret Cancer Centre · CASidney Kimmel Comprehensive Cancer Center · USTel Aviv University · ILThe Ohio State University Wexner Medical Center · USThe University of Melbourne · AUUniversidade de São Paulo · BRUniversité de Bordeaux · FRUniversity of Siena · IT

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Jennifer A. Woyach · 1985 to 2026
$132.3M
NCI NIH HHS P30 CA016058
6 · The paper itself

Abstract

purposePembrolizumab demonstrated durable antitumor activity in patients with previously treated, advanced microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) tumors, including endometrial cancer, in the nonrandomized, open-label, multicohort, phase II KEYNOTE-158 study (NCT02628067). We report efficacy and safety outcomes for patients with MSI-H/dMMR endometrial cancer enrolled in KEYNOTE-158.

methodsEligible patients from cohorts D (endometrial cancer, regardless of MSI-H/dMMR status) and K (any MSI-H/dMMR solid tumor, except colorectal) with previously treated, advanced MSI-H/dMMR endometrial cancer received pembrolizumab 200 mg once every 3 weeks for 35 cycles. The primary end point was objective response rate per RECIST version 1.1 by independent central radiologic review. Secondary end points included duration of response, progression-free survival, overall survival, and safety.

resultsAs of October 5, 2020, 18 of 90 treated patients (20%) had completed 35 cycles of pembrolizumab and 52 (58%) had discontinued treatment. In the efficacy population (patients who received ≥ 1 dose of pembrolizumab and had ≥ 26 weeks of follow-up; N = 79), the median time from first dose to data cutoff was 42.6 (range, 6.4-56.1) months. The objective response rate was 48% (95% CI, 37 to 60), and median duration of response was not reached (2.9-49.7+ months). Median progression-free survival was 13.1 (95% CI, 4.3 to 34.4) months, and median overall survival was not reached (95% CI, 27.2 months to not reached). Among all treated patients, 76% had ≥ 1 treatment-related adverse event (grades 3-4, 12%). There were no fatal treatment-related events. Immune-mediated adverse events or infusion reactions occurred in 28% of patients (grades 3-4, 7%; no fatal events).

conclusionPembrolizumab demonstrated robust and durable antitumor activity and encouraging survival outcomes with manageable toxicity in patients with previously treated, advanced MSI-H/dMMR endometrial cancer.

Indexed as

DNA Mismatch RepairMicrosatellite InstabilityAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiomarkers, TumorEndometrial NeoplasmsFemaleFollow-Up StudiesHumansMiddle AgedNon-Randomized Controlled Trials as TopicPrognosisRetrospective StudiesAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalBiomarkers, Tumorpembrolizumab

Identifiers

PMID34990208
PMCPMC8887941
OpenAlexW4206041598

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.