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

Baek Yeol Ryoo, Ann Li Cheng, Zhenggang Ren, Tae You Kim, Hongming Pan, Kun Ming Rau, Hye Jin Choi, Joong Won Park, Jee Hyun Kim, Chia Jui Yen, Ho Yeong Lim, Dongli Zhou, Josef Straub, Juergen Scheele, Karin Berghoff, Shukui Qin

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2 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)200-208
Number of pages9
JournalBritish Journal of Cancer
Volume125
Issue number2
DOIs
Publication statusPublished - 2021 Jul 20

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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