Evidence map›Paper›PMID 35466070›Full record

ArticleClinical lung cancer2022

Safety of Tepotinib in Patients With MET Exon 14 Skipping NSCLC and Recommendations for Management.

Remi Veillon, Hiroshi Sakai, Xiuning Le, Enriqueta Felip, Alexis B Cortot, Egbert F Smit, Keunchil Park, Frank Griesinger, Christian Britschgi, Yi-Long Wu and 7 more

Open access · hybridAbstract read
In one paragraph

Article in Clinical lung cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
1.8field-weighted citation impact, top 14% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 13 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 15 institutions in 12 countries.

Remi VeillonCHU Bordeaux, Service des Maladies Respiratoires, Bordeaux, France. Electronic address: remi.veillon@chu-bordeaux.fr.
Hiroshi SakaiDepartment of Thoracic Oncology, Saitama Cancer Center, Saitama, Japan.
Xiuning LeDepartment of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Enriqueta FelipDepartment of Oncology, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Alexis B CortotUniv. Lille, CHU Lille, CNRS, Inserm, Institut Pasteur de Lille, UMR9020 - UMR-S 1277 - Canther, F-59000 Lille, France.
Egbert F SmitNetherlands Cancer Institute, Amsterdam, The Netherlands.
Keunchil ParkSamsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Frank GriesingerPius-Hospital, University Medicine Oldenburg, Department of Hematology and Oncology, University Department Internal Medicine-Oncology, Oldenburg, Germany.
Christian BritschgiDepartment of Medical Oncology and Hematology, Comprehensive Cancer Center Zurich, University Hospital Zurich, Zurich, Switzerland.
Yi-Long WuGuangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.
Barbara MeloskyMedical Oncology, The University of British Columbia, Vancouver, Canada.
Shobhit BaijalUniversity Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Gilberto de Castro JrDepartment of Clinical Oncology, Hospital Sírio-Libanês, São Paulo, Brazil.
Michaela SedovaCytel Czech Republic, s.r.o., Prague, Czech Republic.
Karin BerghoffGlobal Patient Safety, the healthcare business of Merck KGaA, Darmstadt, Germany.
Gordon OttoGlobal Clinical Development, the healthcare business of Merck KGaA, Darmstadt, Germany.
Paul K PaikThoracic Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Medicine, Weill Cornell Medical College, New York, NY.
Merck (Germany) · DECentre Hospitalier Universitaire de Bordeaux · FRCentre National de la Recherche Scientifique · FRGuangdong Academy of Medical Sciences · CNHospital Sírio-Libanês · BRMemorial Sloan Kettering Cancer Center · USPius Hospital Oldenburg · DESaitama Cancer Center · JPSamsung Medical Center · KRThe Netherlands Cancer Institute · NLThe University of Texas MD Anderson Cancer Center · USUniversity Hospital of Zurich · CHUniversity Hospitals Birmingham NHS Foundation Trust · GBUniversity of British Columbia · CAVall d'Hebron Institute of Oncology · ES

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

introductionThe MET inhibitor tepotinib demonstrated durable clinical activity in patients with advanced MET exon 14 (METex14) skipping NSCLC. We report detailed analyses of adverse events of clinical interest (AECIs) in VISION, including edema, a class effect of MET inhibitors. PATIENTS AND

methodsIncidence, management, and time to first onset/resolution were analyzed for all-cause AECIs, according to composite categories (edema, hypoalbuminemia, creatinine increase, and ALT/AST increase) or individual preferred terms (pleural effusion, nausea, diarrhea, and vomiting), for patients with METex14 skipping NSCLC in the phase II VISION trial.

resultsOf 255 patients analyzed (median age: 72 years), edema, the most common AECI, was reported in 69.8% (grade 3, 9.4%; grade 4, 0%). Median time to first edema onset was 7.9 weeks (range: 0.1-58.3). Edema was manageable with supportive measures, dose reduction (18.8%), and/or treatment interruption (23.1%), and rarely prompted discontinuation (4.3%). Other AECIs were also manageable and predominantly mild/moderate: hypoalbuminemia, 23.9% (grade 3, 5.5%); pleural effusion, 13.3% (grade ≥ 3, 5.1%); creatinine increase, 25.9% (grade 3, 0.4%); nausea, 26.7% (grade 3, 0.8%), diarrhea, 26.3% (grade 3, 0.4%), vomiting 12.9% (grade 3, 1.2%), and ALT/AST increase, 12.2% (grade ≥ 3, 3.1%). GI AEs typically occurred early and resolved in the first weeks.

conclusionTepotinib was well tolerated in the largest trial of a MET inhibitor in METex14 skipping NSCLC. The most frequent AEs were largely mild/moderate and manageable with supportive measures and/or dose reduction/interruption, and caused few withdrawals in this elderly population.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsProtein Kinase InhibitorsAgedClinical Trials, Phase II as TopicCreatinineDiarrheaEdemaExonsHumansHypoalbuminemiaMutationNauseaPiperidinesPleural EffusionPyridazinesCreatininePiperidinesProtein Kinase InhibitorsPyridazinesPyrimidinestepotinibAdverse eventEdemaMET inhibitorNauseaNon–small cell lung cancer

Identifiers

PMID35466070
PMCPMC10068910
OpenAlexW4220881379

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.