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- Title
Randomised Phase 1b/2 trial of tepotinib vs sorafenib in Asian patients with advanced hepatocellular carcinoma with MET overexpression.
- Authors
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
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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).<bold>Results: </bold>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.<bold>Conclusions: </bold>Tepotinib improved TTP versus sorafenib and was generally well tolerated in SACT-naive Asian patients with aHCC with MET overexpression.<bold>Trial Registration: </bold>ClinicalTrials.gov NCT01988493.
- Publication
British Journal of Cancer, 2021, Vol 125, Issue 2, p200
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/s41416-021-01380-3