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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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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.
Author(s)
류백렬Ann-Li ChengChia Jui YenDongli ZhouHo Yeong LimHongming PanHye Jin ChoiJee Hyun KimJoong-Won ParkJosef StraubJuergen ScheeleKarin BerghoffKun-Ming RauShukui QinTae-You KimZhenggang Ren
Issued Date
2021
Type
Article
DOI
10.1038/s41416-021-01380-3
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8325
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_proquest_miscellaneous_2525650433&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Randomised%20Phase%201b%2F2%20trial%20of%20tepotinib%20vs%20sorafenib%20in%20Asian%20patients%20with%20advanced%20hepatocellular%20carcinoma%20with%20MET%20overexpression&offset=0&pcAvailability=true
Publisher
BRITISH JOURNAL OF CANCER
Location
영국
Language
한국어
ISSN
0007-0920
Citation Volume
125
Citation Number
2
Citation Start Page
200
Citation End Page
208
Appears in Collections:
Medicine > Medicine
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