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A phase II study of tepotinib in patients with advanced solid cancers harboring MET exon 14 skipping mutations or amplification (KCSG AL19-17)

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dc.contributor.author정희철-
dc.date.accessioned2025-07-09T08:30:57Z-
dc.date.available2025-07-09T08:30:57Z-
dc.date.issued2024-09-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/206407-
dc.description.abstractBackground: We evaluated the efficacy and safety of tepotinib in patients with various solid cancers harboring MET exon 14 skipping mutation (METex14) or MET gene amplification. Patients and methods: A phase II, multicenter study was conducted in patients with advanced or metastatic solid cancers who progressed after standard treatment, harboring either METex14 or MET amplification detected in tissue-based next-generation sequencing (NGS). The primary endpoint was objective response rate (ORR). For exploratory analyses, we analyzed the gene profiles using plasma NGS test. Results: Thirty-five patients were enrolled. The ORR was 57.6% for all patients, 52.2% for those with METex14, and 70% for those with MET amplification. Median progression-free survival (PFS) was 8 months [95% confidence interval (CI) 4.5-11.5 months] and median overall survival (OS) was 14 months (95% CI 7.8-20.2 months) in all patients. For patients with non-small-cell lung cancer with METex14, the median PFS was 9 months (95% CI 4.7-13.4 months) and the median OS was 17 months [95% CI not applicable (NA)-NA]. For patients with MET amplification, the median PFS was 7 months (95% CI 1.5-12.5 months) and the median OS was 10 months (95% CI 5.8-14.2 months). The ORR of patients with MET dysregulation detected by plasma NGS was 72.2%, whereas the ORR was 30% in those without detection. The most common adverse events were peripheral edema, asthenia, transaminase elevation, and anorexia, mostly grade 1 or 2. Conclusions: Tepotinib demonstrated consistent antitumor activity in patients with METex14, and promising antitumor activity in various cancers with MET amplification. Detection of MET dysregulation by plasma NGS may predict the response to tepotinib.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherBMJ-
dc.relation.isPartOfESMO OPEN-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAged, 80 and over-
dc.subject.MESHExons* / genetics-
dc.subject.MESHFemale-
dc.subject.MESHGene Amplification*-
dc.subject.MESHHigh-Throughput Nucleotide Sequencing / methods-
dc.subject.MESHHumans-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHMutation*-
dc.subject.MESHNeoplasms* / drug therapy-
dc.subject.MESHNeoplasms* / genetics-
dc.subject.MESHPiperidines-
dc.subject.MESHProto-Oncogene Proteins c-met* / genetics-
dc.subject.MESHPyridazines-
dc.subject.MESHPyrimidines / pharmacology-
dc.subject.MESHPyrimidines / therapeutic use-
dc.titleA phase II study of tepotinib in patients with advanced solid cancers harboring MET exon 14 skipping mutations or amplification (KCSG AL19-17)-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorE J Kang-
dc.contributor.googleauthorY Yang-
dc.contributor.googleauthorS Lee-
dc.contributor.googleauthorY J Kim-
dc.contributor.googleauthorS M Lim-
dc.contributor.googleauthorM-J Ahn-
dc.contributor.googleauthorY J Choi-
dc.contributor.googleauthorY Lee-
dc.contributor.googleauthorT M Kim-
dc.contributor.googleauthorI Kim-
dc.contributor.googleauthorH K Ahn-
dc.contributor.googleauthorH-C Jeung-
dc.contributor.googleauthorS I Lee-
dc.contributor.googleauthorS Y Oh-
dc.contributor.googleauthorW K Bae-
dc.contributor.googleauthorH Ryu-
dc.contributor.googleauthorK H Park-
dc.contributor.googleauthorK H Lee-
dc.identifier.doi10.1016/j.esmoop.2024.103668-
dc.contributor.localIdA03794-
dc.relation.journalcodeJ03799-
dc.identifier.eissn2059-7029-
dc.identifier.pmid39214049-
dc.subject.keywordMET amplification-
dc.subject.keywordMET exon 14 skipping mutation-
dc.subject.keywordsolid tumor-
dc.subject.keywordtepotinib-
dc.contributor.alternativeNameJeung, Hei Cheul-
dc.contributor.affiliatedAuthor정희철-
dc.citation.volume9-
dc.citation.number9-
dc.citation.startPage103668-
dc.identifier.bibliographicCitationESMO OPEN, Vol.9(9) : 103668, 2024-09-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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