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Poster display session

3451 - Final data from a phase Ib trial of tepotinib in Asian patients with advanced hepatocellular carcinoma (HCC)


09 Sep 2017


Poster display session


Shukui Qin


Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369


S. Qin1, T. Kim2, H.Y. Lim3, B. Ryoo4, D. Zhou5, C. Zhao6, A. Becker7, A. Cheng8

Author affiliations

  • 1 Medical Oncology Department, Nanjing Bayi Hospital, 210002 - Nanjing/CN
  • 2 Oncology Department, Seoul National University Hospital, 110744 - Seoul/KR
  • 3 Department Of Medicine, Samsung Medical Center, Sungkyunkwan University, Seoul/KR
  • 4 Department Of Oncology, Asan Medical Center, University of Ulsan College of Medicine, 138-736 - Seoul/KR
  • 5 Biostatistics, Merck Serono Pharmaceutical R&D Co, Beijing/CN
  • 6 Clinical Oncology, EMD Serono, Billerica/US
  • 7 Clinical Pharmacology, Merck KGaA, Darmstadt/DE
  • 8 Department Of Oncology, National Taiwan University Hospital, 100 - Taipei/TW


Abstract 3451


Therapeutic outcomes for patients (pts) with advanced hepatocellular carcinoma (HCC) are currently poor, despite the introduction of new therapies. c-Met is a potential therapeutic target in HCC, and c-Met inhibitors have demonstrated activity in preclinical HCC models. Tepotinib (MSC2156119J) is a highly selective c-Met inhibitor that has favorable safety and promising clinical activity, particularly against c-Met+ solid tumors. We report the final results of a phase Ib trial of tepotinib in pts with advanced HCC.


Enrolled pts were Asian adults with confirmed HCC of BCLC Stage C, Child-Pugh Class A liver function without encephalopathy, and ECOG PS 0–2. Pts received tepotinib 300, 500 (the RP2D), or 1,000 mg/day on a 21-day cycle. c-Met expression was retrospectively determined by IHC (c-Met+ defined as ≥ 50% tumor IHC2+/3+). The primary objective was to confirm the recommended phase II dose (RP2D) of tepotinib.


No dose-limiting toxicities were observed in the 27 pts enrolled (median age 57 [38-69]; male 23; ECOG PS 0/1 11/16), who received tepotinib 300 mg/day (n = 7), 500 mg/day (n = 14), or 1,000 mg/day (n = 6, 3 with dose reduction). 22 pts had treatment-related treatment-emergent adverse events (TRTEAEs), most commonly diarrhea (n = 10), nausea (n = 8), elevated AST (n = 7), and elevated ALT (n = 6). The most common grade ≥3 TRTEAEs were elevated AST (n = 3), elevated ALT (n = 3), and elevated lipase (n = 3). Best overall response (BOR) was partial response (PR) in 2 pts, of duration 19.0 months (500 mg) and 4.4 months (1,000 mg). 8 pts had a BOR of stable disease (SD), 14 pts had PD, 1pt had Non-CR/Non-PD, 2pts were not evaluable. 5 pts had progression-free survival >8 months. Tumor c-Met status was available for 26 pts; of 7 pts with c-Met+ tumors, 2 had a PR and 2 had SD. PK and exploratory biomarkers were investigated.


Tepotinib had antitumor activity in Asian pts with advanced HCC, particularly those with c-Met+ tumors, and was well tolerated at doses up to 1,000 mg/day. A maximum tolerated dose was not defined. The efficacy and safety of first-line tepotinib in pts with c-Met+ HCC are being compared with those of sorafenib in the phase II part of this study.

Clinical trial identification


Legal entity responsible for the study

Merck KGaA


Merck KGaA


D. Zhou, C. Zhao, A. Becker: Employee of Merck. All other authors have declared no conflicts of interest.

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