Cited 23 times in
Randomised Phase 1b/2 trial of tepotinib vs sorafenib in Asian patients with advanced hepatocellular carcinoma with MET overexpression
DC Field | Value | Language |
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dc.contributor.author | 최혜진 | - |
dc.date.accessioned | 2022-11-24T00:39:43Z | - |
dc.date.available | 2022-11-24T00:39:43Z | - |
dc.date.issued | 2021-07 | - |
dc.identifier.issn | 0007-0920 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190868 | - |
dc.description.abstract | Background: This open-label, Phase 1b/2 study evaluated the highly selective MET inhibitor tepotinib in systemic anticancer treatment (SACT)-naive Asian patients with advanced hepatocellular carcinoma (aHCC) with MET overexpression. Methods: In Phase 2b, tepotinib was orally administered once daily (300, 500 or 1,000 mg) to Asian adults with aHCC. The primary endpoints were dose-limiting toxicities (DLTs) and adverse events (AEs). Phase 2 randomised SACT-naive Asian adults with aHCC with MET overexpression to tepotinib (recommended Phase 2 dose [RP2D]) or sorafenib 400 mg twice daily. The primary endpoint was independently assessed time to progression (TTP). Results: In Phase 1b (n = 27), no DLTs occurred; the RP2D was 500 mg. In Phase 2 (n = 90, 45 patients per arm), the primary endpoint was met: independently assessed TTP was significantly longer with tepotinib versus sorafenib (median 2.9 versus 1.4 months, HR = 0.42, 90% confidence interval: 0.26-0.70, P = 0.0043). Progression-free survival and objective response also favoured tepotinib. Treatment-related Grade ≥3 AE rates were 28.9% with tepotinib and 45.5% with sorafenib. Conclusions: Tepotinib improved TTP versus sorafenib and was generally well tolerated in SACT-naive Asian patients with aHCC with MET overexpression. Trial registration: ClinicalTrials.gov NCT01988493. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | Nature Publishing Group on behalf of Cancer Research UK | - |
dc.relation.isPartOf | BRITISH JOURNAL OF CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Administration, Oral | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Asians / genetics | - |
dc.subject.MESH | Carcinoma, Hepatocellular / drug therapy* | - |
dc.subject.MESH | Carcinoma, Hepatocellular / genetics | - |
dc.subject.MESH | Drug Administration Schedule | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Liver Neoplasms / drug therapy* | - |
dc.subject.MESH | Liver Neoplasms / genetics | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Piperidines / administration & dosage* | - |
dc.subject.MESH | Piperidines / adverse effects | - |
dc.subject.MESH | Proto-Oncogene Proteins c-met / genetics* | - |
dc.subject.MESH | Pyridazines / administration & dosage* | - |
dc.subject.MESH | Pyridazines / adverse effects | - |
dc.subject.MESH | Pyrimidines / administration & dosage* | - |
dc.subject.MESH | Pyrimidines / adverse effects | - |
dc.subject.MESH | Sorafenib / administration & dosage* | - |
dc.subject.MESH | Sorafenib / adverse effects | - |
dc.subject.MESH | Survival Analysis | - |
dc.subject.MESH | Treatment Outcome | - |
dc.subject.MESH | Up-Regulation* | - |
dc.title | Randomised Phase 1b/2 trial of tepotinib vs sorafenib in Asian patients with advanced hepatocellular carcinoma with MET overexpression | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Baek-Yeol Ryoo | - |
dc.contributor.googleauthor | Ann-Li Cheng | - |
dc.contributor.googleauthor | Zhenggang Ren | - |
dc.contributor.googleauthor | Tae-You Kim | - |
dc.contributor.googleauthor | Hongming Pan | - |
dc.contributor.googleauthor | Kun-Ming Rau | - |
dc.contributor.googleauthor | Hye Jin Choi | - |
dc.contributor.googleauthor | Joong-Won Park | - |
dc.contributor.googleauthor | Jee Hyun Kim | - |
dc.contributor.googleauthor | Chia Jui Yen | - |
dc.contributor.googleauthor | Ho Yeong Lim | - |
dc.contributor.googleauthor | Dongli Zhou | - |
dc.contributor.googleauthor | Josef Straub | - |
dc.contributor.googleauthor | Juergen Scheele | - |
dc.contributor.googleauthor | Karin Berghoff | - |
dc.contributor.googleauthor | Shukui Qin | - |
dc.identifier.doi | 10.1038/s41416-021-01380-3 | - |
dc.contributor.localId | A04219 | - |
dc.relation.journalcode | J00406 | - |
dc.identifier.eissn | 1532-1827 | - |
dc.identifier.pmid | 33972742 | - |
dc.contributor.alternativeName | Choi, Hye Jin | - |
dc.contributor.affiliatedAuthor | 최혜진 | - |
dc.citation.volume | 125 | - |
dc.citation.number | 2 | - |
dc.citation.startPage | 200 | - |
dc.citation.endPage | 208 | - |
dc.identifier.bibliographicCitation | BRITISH JOURNAL OF CANCER, Vol.125(2) : 200-208, 2021-07 | - |
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