Evidence map›Paper›PMID 34037224›Full record

ArticleJapanese journal of clinical oncology2021

Tepotinib in patients with NSCLC harbouring MET exon 14 skipping: Japanese subset analysis from the Phase II VISION study.

Hiroshi Sakai, Masahiro Morise, Terufumi Kato, Shingo Matsumoto, Tomohiro Sakamoto, Toru Kumagai, Takaaki Tokito, Shinji Atagi, Toshiyuki Kozuki, Hiroshi Tanaka and 7 more

Open access · hybridAbstract read
In one paragraph

Article in Japanese journal of clinical oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 11% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Liquid and Tissue Biopsies for Identifying MET Exon 14 Skipping NSCLC: Analyses from the Phase II VISION Study of Tepotinib.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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  3. Vebreltinib for Advanced Non-Small Cell Lung Cancer Harboring c-Met Exon 14 Skipping Mutation: A Multicenter, Single-Arm, Phase II KUNPENG Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
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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 14 institutions in 3 countries.

Hiroshi SakaiDepartment of Thoracic Oncology, Saitama Cancer Center, Ina, Japan.
Masahiro MoriseDepartment of Respiratory Medicine, Nagoya University Hospital, Nagoya, Japan.
Terufumi KatoDepartment of Respiratory Medicine, Kanagawa Cancer Center, Yokohama, Japan.
Shingo MatsumotoDepartment of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Tomohiro SakamotoDepartment of Respiratory Medicine, Tottori University Hospital, Yonago, Japan.
Toru KumagaiDepartment of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Japan.
Takaaki TokitoDepartment of Lung Cancer Center, Kurume University Hospital, Kurume, Japan.
Shinji AtagiDepartment of Thoracic Oncology, NHO Kinki-Chuo Chest Medical Center, Sakai, Japan.
Toshiyuki KozukiDepartment of Respiratory Medicine, NHO Shikoku Cancer Center, Matsuyama, Japan.
Hiroshi TanakaDepartment of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.
Kenichi ChikamoriDepartment of Oncology, NHO Yamaguchi-Ube Medical Center, Ube, Japan.
Naofumi ShinagawaDepartment of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan.
Hiroaki TakeokaDepartment of Respiratory Medicine, NHO Kyushu Medical Center, Fukuoka, Japan.
Rolf BrunsDepartment of Biostatistics, Merck KGaA, Darmstadt, Germany.
Josef StraubTranslational Medicine, Department of Clinical Biomarkers and Companion Diagnostics, Merck KGaA, Darmstadt, Germany.
Karl Maria SchumacherGlobal Clinical Development, Merck KGaA, Darmstadt, Germany.
Paul K PaikDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Merck (Germany) · DECornell University · USHokkaido University · JPKanagawa Cancer CenterKurume University Hospital · JPNagoya University Hospital · JPNational Cancer Center Hospital East · JPNational Kinki Chuo Hospital for Chest Disease · JPNational Kyushu Medical Center · JPNiigata Cancer Center Hospital · JPOsaka Medical Center for Cancer and Cardiovascular Diseases · JPSaitama Cancer Center · JPShikoku Cancer Center · JPTottori University Hospital · JP

Funding

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

Abstract

backgroundMET exon 14 skipping is an oncogenic driver occurring in 3-4% of non-small cell lung cancer (NSCLC). The MET inhibitor tepotinib has demonstrated clinical efficacy in patients with MET exon 14 skipping NSCLC. Here, we present data from Japanese patients in the Phase II VISION study, evaluating the efficacy and safety of tepotinib.

methodsIn the open-label, single-arm, Phase II VISION study, patients with advanced/metastatic NSCLC with MET exon 14 skipping received oral tepotinib 500 mg once daily. The primary endpoint was objective response by independent review. Subgroup analyses of Japanese patients were preplanned.

resultsAs of 1 January 2020, 19 Japanese patients received tepotinib and were evaluated for safety, 15 of whom had ≥9 months' follow-up and were also analysed for efficacy. By independent review, objective response rate (ORR) was 60.0% (95% confidence interval [CI]: 32.3, 83.7), median duration of response was not reached (95% CI: 6.9, not estimable [ne]), and progression-free survival was 11.0 months (95% CI: 1.4, ne). ORR in patients with MET exon 14 skipping identified by liquid biopsy (n = 8) was 87.5% (95% CI: 47.3, 99.7), and by tissue biopsy (n = 12) was 50.0% (95% CI: 21.1, 78.9). Patients' quality of life was maintained with tepotinib treatment. Among patients evaluated for safety, the most common treatment-related adverse events (any grade) were blood creatinine increase and peripheral oedema (12 and nine patients, respectively).

conclusionsTepotinib demonstrated robust and durable clinical efficacy in Japanese patients with advanced NSCLC harbouring MET exon 14 skipping, identified by either liquid or tissue biopsy. The main adverse events, blood creatinine increase and peripheral oedema, were manageable.

Indexed as

Carcinoma, Non-Small-Cell LungLung NeoplasmsPiperidinesProto-Oncogene Proteins c-metPyridazinesPyrimidinesAgedAged, 80 and overAntineoplastic AgentsClinical Trials, Phase II as TopicExonsFemaleHumansJapanMaleMiddle AgedAntineoplastic AgentsMAS1 protein, humanMET protein, humanPiperidinesProtein Kinase InhibitorsProto-Oncogene MasProto-Oncogene Proteins c-metPyridazinesPyrimidinestepotinibcarcinomaliquid biopsynon-small-cell lungprotein kinase inhibitorsproto-oncogene proteins c-Mettepotinib

Identifiers

PMID34037224
PMCPMC8326385
OpenAlexW3164056006

What OpenQuestion holds

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Registered trials

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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.