Evidence map›Paper›PMID 38575731›Full record

Trial reportBritish journal of cancer2024

Efficacy and safety of tepotinib in Asian patients with advanced NSCLC with MET exon 14 skipping enrolled in VISION.

Terufumi Kato, James Chih-Hsin Yang, Myung-Ju Ahn, Hiroshi Sakai, Masahiro Morise, Yuh-Min Chen, Ji-Youn Han, Jin-Ji Yang, Jun Zhao, Te-Chun Hsia and 7 more

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in British journal 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 NCT02864992 (A Phase II Single-arm Trial to Investigate Tepotinib in Advanced), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

NCT02864992 phase2active not recruitingnot on this map

A Phase II Single-arm Trial to Investigate Tepotinib in Advanced (Locally Advanced or Metastatic) Non-small Cell Lung Cancer With METex14 Skipping Alterations or MET Amplification (VISION)

TypeinterventionalSponsorEMD Serono Research & Development Institute, Inc.Ran2016 to 2026Enrolled337ConditionsAdvanced (Stage IIIB/IV) Non-small Cell Lung Cancer (NSCLC) With MET Exon 14 (METex14) Skipping Alterations or MET Amplification, Lung Adenocarcinoma Stage IIIB/IVArmsTepotinib
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Review
  5. Article
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 13 institutions in 6 countries.

Terufumi KatoDepartment of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
James Chih-Hsin YangDepartment of Medical Oncology, National Taiwan University Cancer Center, Taipei, Taiwan. chihyang@ntu.edu.tw.ORCID 0000-0002-5586-5138
Myung-Ju AhnDivision of Hematology Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Hiroshi SakaiDepartment of Thoracic Oncology, Saitama Cancer Center, Kitaadachi-gun, Japan.
Masahiro MoriseDepartment of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Yuh-Min ChenDepartment of Chest Medicine, Taipei Veterans General Hospital, and School of Medicine, National Yang-Ming University, Taipei, Taiwan.
Ji-Youn HanThe Center for Lung Cancer, National Cancer Center, Goyang, Republic of Korea.
Jin-Ji YangDepartment of Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China.
Jun ZhaoDepartment of Thoracic Oncology, Peking University Cancer Hospital and Institute, Beijing, China.
Te-Chun HsiaDepartment of Internal Medicine, China Medical University Hospital, Taichung, Taiwan.
Karin BerghoffGlobal Patient Safety, Merck Healthcare KGaA, Darmstadt, Germany.
Rolf BrunsDepartment of Biostatistics, Merck Healthcare KGaA, Darmstadt, Germany.
Helene VioixGlobal Evidence and Value Department, Merck Healthcare KGaA, Darmstadt, Germany.
Simone LangGlobal Clinical Development, Merck Healthcare KGaA, Darmstadt, Germany.
Andreas JohneGlobal Clinical Development, Merck Healthcare KGaA, Darmstadt, Germany.
Xiuning LeDepartment of Thoracic Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Paul K PaikDepartment of Medicine, Weill Cornell Medical College, New York, NY, USA.
Merck (Germany) · DEChina Medical University · TWGuangdong General Hospital · CNKanagawa Prefectural Hospital Organization · JPMemorial Sloan Kettering Cancer Center · USNagoya University · JPNational Cancer Center · KRNational Taiwan University · TWNational Yang Ming Chiao Tung University · TWPeking University · CNSaitama Cancer Center · JPSamsung Medical Center · KRThe University of Texas MD Anderson Cancer Center · US

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

backgroundTepotinib, a MET inhibitor approved for the treatment of MET exon 14 (METex14) skipping NSCLC, demonstrated durable clinical activity in VISION (Cohort A + C; N = 313): objective response rate (ORR) 51.4% (95% CI: 45.8, 57.1); median duration of response (mDOR) 18.0 months (95% CI: 12.4, 46.4). We report outcomes in Asian patients from VISION (Cohort A + C) (cut-off: November 20, 2022).

methodsPatients with advanced METex14 skipping NSCLC, detected by liquid or tissue biopsy, received tepotinib 500 mg (450 mg active moiety) once daily. PRIMARY ENDPOINT: objective response (RECIST 1.1) by independent review. Secondary endpoints included: DOR, progression-free survival (PFS), overall survival (OS), safety, and health-related quality of life (HRQoL).

resultsAcross treatment lines in 106 Asian patients (39.6% female, 43.4% smoking history, 79.2% adenocarcinoma, 47.2% treatment-naive), ORR was 56.6% (95% CI: 46.6, 66.2), mDOR 18.5 months (10.4, ne), mPFS 13.8 months (10.8, 22.0), and mOS 25.5 months (19.3, 36.4). Consistent efficacy observed, regardless of baseline characteristics. HRQoL remained stable during treatment. Treatment-related adverse events (TRAEs) occurred in 95.3% of patients (39.6% Grade ≥3). Most common TRAEs: peripheral edema (62.3%), creatinine increase (38.7%).

conclusionsTepotinib demonstrated robust and durable efficacy, with a manageable safety profile, in Asian patients with METex14 skipping NSCLC. CLINICAL

trial registrationNCT02864992.

Indexed as

Carcinoma, Non-Small-Cell LungExonsLung NeoplasmsProto-Oncogene Proteins c-metAdultAgedAged, 80 and overAsian PeopleFemaleHumansMaleMiddle AgedPiperidinesProgression-Free SurvivalPyridazinesPyrimidinesMET protein, humanPiperidinesProto-Oncogene Proteins c-metPyridazinesPyrimidinestepotinib

Identifiers

PMID38575731
PMCPMC11091176
OpenAlexW4393948307

What OpenQuestion holds

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LicenceCC BY
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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.