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Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology

3990 - Phase 2 efficacy and safety data for the MET inhibitor tepotinib in patients (pts) with sorafenib-treated advanced hepatocellular carcinoma (HCC)


21 Oct 2018


Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology


Targeted Therapy

Tumour Site

Hepatobiliary Cancers


Thomas Decaens


Annals of Oncology (2018) 29 (suppl_8): viii205-viii270. 10.1093/annonc/mdy282


T. Decaens1, C. Barone2, E. Assenat3, M. Wermke4, A. Fasolo5, P. Merle6, J.F. Blanc7, V. Grando8, R. Bruns9, J. Straub10, C. Zhao11, S. Faivre12

Author affiliations

  • 1 Institute For Advanced Biosciences, CHU de Grenoble, 38700 - La Tronche/FR
  • 2 Medical Oncology, Policlinico Universitario A. Gemelli, Roma/IT
  • 3 Medical Oncology, CHU Saint Eloi, Montpellier/FR
  • 4 University Cancer Center, University Hospital Carl-Gustav-Carus, 01307 - Dresden/DE
  • 5 Oncology, IRCCS San Raffaele, 20132 - Milan/IT
  • 6 Service D'hépato-gastro-entérologie, Centre Hospitalier de la Croix Rousse, Lyon/FR
  • 7 Hepatology And Medical Oncology, CHU Bordeaux Haut-Lévêque, 33000 - Bordeaux/FR
  • 8 Hepatology, Jean Verdier Hospital, 93140 - Bondy/FR
  • 9 Biostatistic, Merck KGaA, 64293 - Darmstadt/DE
  • 10 Clinical Biomarker & Companion Diagnositics, Merck KGaA, 64293 - Darmstadt/DE
  • 11 Clinical research, EMD Serono Inc, Billerica/US
  • 12 Medical Oncology, Hopital Beaujon, Clichy/FR


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Abstract 3990


MET is a potential therapeutic target in advanced HCC; tepotinib is a highly selective MET inhibitor. Here we report final analysis results from a single-arm multicenter phase 2 study investigating the efficacy and safety of tepotinib in pts with sorafenib-treated advanced MET+ HCC (NCT02115373).


Adults with advanced MET+ HCC, Child-Pugh Class A, Eastern Cooperative Oncology Group performance status 0–1, and ≥4 weeks of prior sorafenib therapy were eligible for treatment. MET status was assessed by immunohistochemistry (2+ or 3+) and in-situ hybridization. Pts received tepotinib at the recommended phase 2 dose (RP2D) of 500 mg once-daily. The primary endpoint was progression-free survival status at 12 weeks; secondary endpoints included safety and other efficacy parameters.


49 pts had received treatment; median (range) duration of therapy was 3.02 (0.03–16.49) months. Median (range) age was 66 (19–82) years and most patients were male (83.7%). The null hypothesis that the rate of progression-free subjects at 12 weeks is ≤ 15% has been rejected as 31/49 pts (63.3%; 90% confidence interval [CI]: 50.5, 74.7) were progression-free at 12 weeks; median PFS was 3.4 months (90% CI: 2.8, 4.2). Overall, there were 4/49 responders (8.2%; 90% CI: 2.8, 17.7; 1 complete and 3 partial responses). Median overall survival was 5.6 months (90% CI: 5.1, 8.2 months). The most common treatment-related adverse events (AEs) were peripheral edema (n = 32; 38.8%), fatigue (n = 10; 18.4%) and diarrhea (n = 16; 16.3%). 17 pts (34.7%) discontinued treatment due to AEs and 1 pt (2%) died from a treatment-related AE (hypoglycemic coma).


These data indicate that tepotinib has anti-tumor activity in pretreated MET+ advanced HCC and was well tolerated at the RP2D, with no new safety signals detected.

Clinical trial identification


Legal entity responsible for the study

Merck KGaA, Darmstadt, Germany.


Merck KGaA, Darmstadt, Germany.

Editorial Acknowledgement

Medical writing assistance (funded by Merck KGaA, Darmstadt, Germany) was provided by Martin Quinn, PhD of Bioscript Science (Macclesfield, UK).


C. Barone: Advisory board membership, Fee for presentation: Merck Serono. M. Wermke: Honaries: BMS, Novartis, Roche, Bayer, Glenmark, AstraZeneca; Travel reimbursements: AstraZeneca, BMS, MSD, Novartis, Glenmark; Research funding: Novartis, Pfizer. P. Merle: Advisory board member: Bayer, Ipsen, BMS. J.F. Blanc: Advisory board member: Bayer, Lilly Oncology, BMS, Onxeo, Esai, Ipsen. R. Bruns, J. Straub: Employee: Merck KGaA. C. Zhao: Employee: EMD Serono Inc. S. Faivre: Consultant, Clinical trials grants: Blueprint, BMS, Bayer Pharma, Eli Lilly, Ipsen, Merck Serono, MSD, Novartis. All other authors have declared no conflicts of interest.

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