Efficacy, Safety, and Pharmacokinetic of MSC2156119J in Asian Participants With Hepatocellular Carcinoma

Summary

This is an open-label, integrated, Phase 1b/2 trial to determine the recommended Phase 2 dose (RP2D) and to evaluate the efficacy, safety, and pharmacokinetic of MSC2156119J as first-line treatment versus sorafenib in subjects with MET+, Barcelona Clinic Liver Cancer (BCLC) Stage C, systemic treatment naive advanced hepatocellular carcinoma (HCC) and Child-Pugh class A liver function.

Timeline

Start

2014-01-06

Primary completion

2018-02-05

Completion

2020-12-03

Outcome

Met primary endpoint

paper the primary endpoint was met: independently assessed TTP was significantly longer with tepotinib versus sorafenib PMID 33972742 ↗

registry analysis (equivalence test); Phase 2: Tepotinib vs Phase 2 Sorafenib; p = 0.0087; Hazard Ratio (HR) 0.46 (90% CI 0.28 to 0.76); Log Rank NCT01988493 ↗

Publications

• Results Ryoo BY, Cheng AL, Ren Z, Kim TY, Pan H, Rau KM, Choi HJ, Park JW, Kim JH, Yen CJ, Lim HY, Zhou D, Straub J, Scheele J, Berghoff K, Qin S. Randomised Phase 1b/2 trial of tepotinib vs sorafenib in Asian patients with advanced hepatocellular carcinoma with MET overexpression. Br J Cancer. 2021 Jul;125(2):200-208. doi: 10.1038/s41416-021-01380-3. Epub 2021 May 10.
• Xiong W, Hietala SF, Nyberg J, Papasouliotis O, Johne A, Berghoff K, Goteti K, Dong J, Girard P, Venkatakrishnan K, Strotmann R. Exposure-response analyses for the MET inhibitor tepotinib including patients in the pivotal VISION trial: support for dosage recommendations. Cancer Chemother Pharmacol. 2022 Jul;90(1):53-69. doi: 10.1007/s00280-022-04441-3. Epub 2022 Jun 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sorafenib	Small molecule	400 mg	Oral
Subject	Tepotinib	Small molecule	300 mg	Oral
Subject	Tepotinib	Small molecule	500 mg	Oral
Subject	Tepotinib	Small molecule	1000 mg	Oral

Indications