Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session

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

Date

09 Sep 2017

Session

Poster display session

Presenters

Shukui Qin

Citation

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

Authors

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
More

Resources

Abstract 3451

Background

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.

Methods

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.

Results

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.

Conclusions

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

NCT01988493

Legal entity responsible for the study

Merck KGaA

Funding

Merck KGaA

Disclosure

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

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.