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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

2086 - Cemiplimab, a human monoclonal anti-PD-1, in patients (pts) with advanced or metastatic hepatocellular carcinoma (HCC): Data from an expansion cohort in a Phase 1 study


20 Oct 2018


Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research


Tumour Site

Hepatobiliary Cancers


Michael Pishvaian


Annals of Oncology (2018) 29 (suppl_8): viii400-viii441. 10.1093/annonc/mdy288


M.J. Pishvaian1, G.J. Weiss2, G.S. Falchook3, N. Yee4, M. Gil-Martin5, S. Shahda6, V. Moreno7, I. Brana8, M. Crittenden9, S. Formenti10, R. Al-Rajabi11, K.P. Papadopoulos12, E. Stankevich13, M. Feng13, J. Li14, M. Mathias15, G. Kroog15, I. Lowy15, M.G. Fury15

Author affiliations

  • 1 Georgetown Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, 20057 - Washington/US
  • 2 Department Of Internal Medicine, University of Arizona College of Medicine - Phoenix, 85004 - Phoenix/US
  • 3 Drug Development, Sarah Cannon Research Institute at HealthONE, 80218 - Denver/US
  • 4 Hematology/oncology, Hematology/Oncology Division and Penn State Cancer Institute, 17033 - Hershey/US
  • 5 L’hospitalet De Llobregat, Institut Català d’Oncologia, 08908 - Barcelona/ES
  • 6 Indiana University School Of Medicine, Indiana University Melvin Bren Simon Cancer Center, 46202 - Indianapolis/US
  • 7 Start Madrid-fjd, Hospital Fundación Jiménez Díaz, 28040 - Madrid/ES
  • 8 Department Of Medical Oncology, Vall D’Hebron Institute of Oncology, Barcelona/ES
  • 9 Earle A. Chiles Research Institute, Robert W. Franz Cancer Center, Providence Portland Medical Center and The Oregon Clinic, 97213 - Portland/US
  • 10 Department Of Radiation oncology, Weill Cornell Medicine, 10065 - New York/US
  • 11 Department Of Internal Medicine, Division Of Hematology/oncology, University of Kansas Cancer Center, 66160-7220 - Kansas City/US
  • 12 Clinical research, START, 78229 - San Antonio/US
  • 13 Clinical Sciences, Regeneron Pharmaceuticals, Inc., 07920 - Basking Ridge/US
  • 14 Biostatistics & Data Management, Regeneron Pharmaceuticals, Inc., 07920 - Basking Ridge/US
  • 15 Clinical Sciences, Regeneron Pharmaceuticals, Inc., Tarrytown/US


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Abstract 2086


For pts with unresectable HCC, systemic therapy options are limited. Sorafenib is approved in the US and Europe for HCC treatment. For pts who progress on sorafenib, regorafenib and nivolumab are approved as second-line therapy. Cemiplimab (REGN2810) has demonstrated encouraging efficacy and safety profile in a Phase 1 dose escalation study in pts with advanced malignancies (NCT02383212). We present results of the Phase 1 HCC expansion cohort.


HCC pts who were not candidates for surgery and had progressed on, could not tolerate, or refused first-line systemic therapy received cemiplimab 3 mg/kg Q2W for up to 48 weeks. The main objectives were to evaluate the safety, tolerability, and antitumour activity of cemiplimab.


As of 1 Sept, 2017, 26 pts were enrolled (25 M/1 F), median (range) age was 65 (40–78) years; 24 pts (92.3%) had ≥1 prior systemic therapy; ECOG performance status was 1 in 19 pts (73.1%), 0 in 6 (23.1%) and missing in 1. Median duration of follow-up was 7.2 (range: 1.8–15.5) months. By investigator assessment, 5 pts (19.2%) had partial response, 14 (53.8%) had stable disease, 6 (23.1%) had progressive disease and 1 was not evaluable. Median progression-free survival was 3.7 months (95% CI: 2.3–9.1). Five pts (19.2%) completed the planned 48-week treatment, and 21 (80.8%) discontinued prematurely, mainly due to disease progression (65.4%). Three of the 5 pts who completed planned treatment remained without disease progression at the last response assessment. The most common treatment-emergent adverse events (TEAEs) of any grade were fatigue (26.9%), decreased appetite, increased aspartate aminotransferase (AST), abdominal pain, pruritus, and dyspnoea (each 23.1%). Grade ≥3 TEAEs occurring in ≥ 2 pts were hyponatraemia (3 pts), autoimmune hepatitis (2 pts) and increased AST (2 pts). Two pts (7.7%) had a TEAE resulting in death: 1 with pulmonary embolism that was considered unrelated to treatment and another with hepatic failure considered possibly related to treatment.


Cemiplimab demonstrated evidence of antitumour activity in pts with advanced or metastatic HCC. The safety profile is comparable with that of other anti-PD-1 inhibitors.

Clinical trial identification


Legal entity responsible for the study

Regeneron Pharmaceutical Inc., and Sanofi.


Regeneron Pharmaceutical Inc. and Sanofi.

Editorial Acknowledgement

Medical writing support under the direction of the authors was provided by Emmanuel Ogunnowo, PhD, of Prime (Knutsford, UK) and funded by Regeneron Pharmaceuticals, Inc. and Sanofi according to Good Publication Practice guidelines (http://annals.org/aim/article/2424869/good-publication-practice-communicating-company-sponsored-medical-research-gpp3).


G.J. Weiss: Personal fees and ownership interest: Circulogene; Ownership interest: Angiex; Personal fees: Paradigm, Igynta, Pfizer, Merck, Idea Pharma, GLG Council, Novartis; Travel/lodging fees: Cambridge Healthtech Institute, Tesaro, and Nantworks; Patent PCT/US2011/020612 issued. G.S. Falchook: Funding for trial for submitted work. N. Yee: Research, travel, accommodation and expenses: Daiichi Sankyo, Foundation Medicine and Caris Life Sciences. S. Shahda: Advisory board fees: Ipsen and Bayer; Research grants: Incyte and Apexian. M. Crittenden: Research funding: Jounce and Nanobiotix. R. Al-Rajabi: Grants: Regeneron Pharmaceuticals, Inc. E. Stankevich: Shareholder and employee: Regeneron Pharmaceuticals, Inc., Shareholder: Celgene, Bristol-Myers Squibb, and Merck. M. Feng: Shareholder and employee: Regeneron Pharmaceuticals, Inc., Shareholder: Bayer. J. Li, M. Mathias, G. Kroog: Shareholder and employee: Regeneron Pharmaceuticals, Inc. I. Lowy: Shareholder and employee, fees for travel and accommodation expenses, leadership: Regeneron Pharmaceuticals, Inc. M.G. Fury: Shareholder, employee, holds patents, royalties, other intellectual property: Regeneron Pharmaceuticals, Inc. All other authors have declared no conflicts of interest.

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