Cited 452 times in
Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations
DC Field | Value | Language |
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dc.contributor.author | 조병철 | - |
dc.date.accessioned | 2020-12-01T16:59:25Z | - |
dc.date.available | 2020-12-01T16:59:25Z | - |
dc.date.issued | 2020-09 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/180074 | - |
dc.description.abstract | Background: A splice-site mutation that results in a loss of transcription of exon 14 in the oncogenic driver MET occurs in 3 to 4% of patients with non-small-cell lung cancer (NSCLC). We evaluated the efficacy and safety of tepotinib, a highly selective MET inhibitor, in this patient population. Methods: In this open-label, phase 2 study, we administered tepotinib (at a dose of 500 mg) once daily in patients with advanced or metastatic NSCLC with a confirmed MET exon 14 skipping mutation. The primary end point was the objective response by independent review among patients who had undergone at least 9 months of follow-up. The response was also analyzed according to whether the presence of a MET exon 14 skipping mutation was detected on liquid biopsy or tissue biopsy. Results: As of January 1, 2020, a total of 152 patients had received tepotinib, and 99 patients had been followed for at least 9 months. The response rate by independent review was 46% (95% confidence interval [CI], 36 to 57), with a median duration of response of 11.1 months (95% CI, 7.2 to could not be estimated) in the combined-biopsy group. The response rate was 48% (95% CI, 36 to 61) among 66 patients in the liquid-biopsy group and 50% (95% CI, 37 to 63) among 60 patients in the tissue-biopsy group; 27 patients had positive results according to both methods. The investigator-assessed response rate was 56% (95% CI, 45 to 66) and was similar regardless of the previous therapy received for advanced or metastatic disease. Adverse events of grade 3 or higher that were considered by investigators to be related to tepotinib therapy were reported in 28% of the patients, including peripheral edema in 7%. Adverse events led to permanent discontinuation of tepotinib in 11% of the patients. A molecular response, as measured in circulating free DNA, was observed in 67% of the patients with matched liquid-biopsy samples at baseline and during treatment. Conclusions: Among patients with advanced NSCLC with a confirmed MET exon 14 skipping mutation, the use of tepotinib was associated with a partial response in approximately half the patients. Peripheral edema was the main toxic effect of grade 3 or higher. (Funded by Merck [Darmstadt, Germany]; VISION ClinicalTrials.gov number, NCT02864992.). | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isPartOf | NEW ENGLAND JOURNAL OF MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Aged, 80 and over | - |
dc.subject.MESH | Antineoplastic Agents / adverse effects | - |
dc.subject.MESH | Antineoplastic Agents / therapeutic use | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung / drug therapy* | - |
dc.subject.MESH | Carcinoma, Non-Small-Cell Lung / genetics | - |
dc.subject.MESH | Edema / chemically induced | - |
dc.subject.MESH | Exons | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lung Neoplasms / drug therapy* | - |
dc.subject.MESH | Lung Neoplasms / genetics | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Mutation* | - |
dc.subject.MESH | Piperidines / adverse effects | - |
dc.subject.MESH | Piperidines / therapeutic use* | - |
dc.subject.MESH | Protein Kinase Inhibitors / adverse effects | - |
dc.subject.MESH | Protein Kinase Inhibitors / therapeutic use* | - |
dc.subject.MESH | Proto-Oncogene Proteins c-met / antagonists & inhibitors* | - |
dc.subject.MESH | Proto-Oncogene Proteins c-met / genetics | - |
dc.subject.MESH | Pyridazines / adverse effects | - |
dc.subject.MESH | Pyridazines / therapeutic use* | - |
dc.subject.MESH | Pyrimidines / adverse effects | - |
dc.subject.MESH | Pyrimidines / therapeutic use* | - |
dc.title | Tepotinib in Non-Small-Cell Lung Cancer with MET Exon 14 Skipping Mutations | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Paul K Paik | - |
dc.contributor.googleauthor | Enriqueta Felip | - |
dc.contributor.googleauthor | Remi Veillon | - |
dc.contributor.googleauthor | Hiroshi Sakai | - |
dc.contributor.googleauthor | Alexis B Cortot | - |
dc.contributor.googleauthor | Marina C Garassino | - |
dc.contributor.googleauthor | Julien Mazieres | - |
dc.contributor.googleauthor | Santiago Viteri | - |
dc.contributor.googleauthor | Helene Senellart | - |
dc.contributor.googleauthor | Jan Van Meerbeeck | - |
dc.contributor.googleauthor | Jo Raskin | - |
dc.contributor.googleauthor | Niels Reinmuth | - |
dc.contributor.googleauthor | Pierfranco Conte | - |
dc.contributor.googleauthor | Dariusz Kowalski | - |
dc.contributor.googleauthor | Byoung Chul Cho | - |
dc.contributor.googleauthor | Jyoti D Patel | - |
dc.contributor.googleauthor | Leora Horn | - |
dc.contributor.googleauthor | Frank Griesinger | - |
dc.contributor.googleauthor | Ji-Youn Han | - |
dc.contributor.googleauthor | Young-Chul Kim | - |
dc.contributor.googleauthor | Gee-Chen Chang | - |
dc.contributor.googleauthor | Chen-Liang Tsai | - |
dc.contributor.googleauthor | James C-H Yang | - |
dc.contributor.googleauthor | Yuh-Min Chen | - |
dc.contributor.googleauthor | Egbert F Smit | - |
dc.contributor.googleauthor | Anthonie J van der Wekken | - |
dc.contributor.googleauthor | Terufumi Kato | - |
dc.contributor.googleauthor | Dilafruz Juraeva | - |
dc.contributor.googleauthor | Christopher Stroh | - |
dc.contributor.googleauthor | Rolf Bruns | - |
dc.contributor.googleauthor | Josef Straub | - |
dc.contributor.googleauthor | Andreas Johne | - |
dc.contributor.googleauthor | Jürgen Scheele | - |
dc.contributor.googleauthor | John V Heymach | - |
dc.contributor.googleauthor | Xiuning Le | - |
dc.identifier.doi | 10.1056/NEJMoa2004407 | - |
dc.contributor.localId | A03822 | - |
dc.relation.journalcode | J02371 | - |
dc.identifier.eissn | 1533-4406 | - |
dc.identifier.pmid | 32469185 | - |
dc.identifier.url | https://www.nejm.org/doi/10.1056/NEJMoa2004407 | - |
dc.contributor.alternativeName | Cho, Byoung Chul | - |
dc.contributor.affiliatedAuthor | 조병철 | - |
dc.citation.volume | 383 | - |
dc.citation.number | 10 | - |
dc.citation.startPage | 931 | - |
dc.citation.endPage | 943 | - |
dc.identifier.bibliographicCitation | NEW ENGLAND JOURNAL OF MEDICINE, Vol.383(10) : 931-943, 2020-09 | - |
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