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Randomised Phase 1b/2 trial of tepotinib vs sorafenib in Asian patients with advanced hepatocellular carcinoma with MET overexpression

British journal of cancer, 2021-07, Vol.125 (2), p.200-208 [Peer Reviewed Journal]

2021. The Author(s). ;The Author(s) 2021. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. ;The Author(s) 2021 ;ISSN: 0007-0920 ;EISSN: 1532-1827 ;DOI: 10.1038/s41416-021-01380-3 ;PMID: 33972742

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Title:
Randomised Phase 1b/2 trial of tepotinib vs sorafenib in Asian patients with advanced hepatocellular carcinoma with MET overexpression
Author: Ryoo, Baek-Yeol ; Cheng, Ann-Li ; Ren, Zhenggang ; Kim, Tae-You ; Pan, Hongming ; Rau, Kun-Ming ; Choi, Hye Jin ; Park, Joong-Won ; Kim, Jee Hyun ; Yen, Chia Jui ; Lim, Ho Yeong ; Zhou, Dongli ; Straub, Josef ; Scheele, Juergen ; Berghoff, Karin ; Qin, Shukui
Subjects: Administration, Oral ; Adult ; Adverse events ; Aged ; Asians - genetics ; Carcinoma, Hepatocellular - drug therapy ; Carcinoma, Hepatocellular - genetics ; Dosage ; Drug Administration Schedule ; Female ; Hepatocellular carcinoma ; Humans ; Liver cancer ; Liver Neoplasms - drug therapy ; Liver Neoplasms - genetics ; Male ; Middle Aged ; Oral administration ; Patients ; Piperidines - administration & dosage ; Piperidines - adverse effects ; Proto-Oncogene Proteins c-met - genetics ; Pyridazines - administration & dosage ; Pyridazines - adverse effects ; Pyrimidines - administration & dosage ; Pyrimidines - adverse effects ; Sorafenib - administration & dosage ; Sorafenib - adverse effects ; Survival Analysis ; Treatment Outcome ; Up-Regulation
Is Part Of: British journal of cancer, 2021-07, Vol.125 (2), p.200-208
Description: 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. 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). 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. Tepotinib improved TTP versus sorafenib and was generally well tolerated in SACT-naive Asian patients with aHCC with MET overexpression. ClinicalTrials.gov NCT01988493.
Publisher: England: Nature Publishing Group
Language: English
Identifier: ISSN: 0007-0920
EISSN: 1532-1827
DOI: 10.1038/s41416-021-01380-3
PMID: 33972742
Source: GFMER Free Medical Journals
MEDLINE
PubMed Central
ProQuest Central

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Randomised Phase 1b/2 trial of tepotinib vs sorafenib in Asian patients with advanced hepatocellular carcinoma with MET overexpression

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