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

2098 - Preliminary results from a subset of patients (pts) with advanced head and neck squamous carcinoma (HNSCC) in a dose-escalation and dose-expansion study of BGB-A317, an anti-PD-1 monoclonal antibody (mAb)


11 Sep 2017


Poster display session


Clinical Research;  Immunotherapy;  Head and Neck Cancers


Lisa Horvath


Annals of Oncology (2017) 28 (suppl_5): v122-v141. 10.1093/annonc/mdx367


L. Horvath1, J. Desai2, S. Sandhu3, A. O'Donnell4, A.G. Hill5, S. Deva6, B. Markman7, M.B. Jameson8, Z. Chen9, X. Tan9, J. Hou10, A. Lim11

Author affiliations

  • 1 Medical Oncology, Chris O’Brien Lifehouse, 2050 - Camperdown/AU
  • 2 Medical Oncology, Peter MacCallum Cancer Centre, 3000 - Melbourne/AU
  • 3 Department Of Oncology, Peter MacCallum Cancer Center, 3002 - Melbourne/AU
  • 4 Endocrine, Diabetes & Research Centre, Wellington Hospital, Wellington/NZ
  • 5 Medical Oncology, Tasman Oncology Research, Southport/AU
  • 6 Internal Medicine, Auckland City Hospital, Auckland/NZ
  • 7 Department Of Oncology, Monash Cancer Center, Monash Health, 3168 - Melbourne/AU
  • 8 Regional Cancer Center, Waikato Hospital, 3240 - Hamilton/NZ
  • 9 Oncology, BeiGene (Beijing) Co. Ltd, Beijing/CN
  • 10 Immunoncology, BeiGene USA, Inc, Emeryville/US
  • 11 Oncology, Linear Clinical Research, Nedlands/AU


Abstract 2098


BGB-A317 is a humanized IgG4 anti-PD-1 mAb that blocks PD-L1/PD-L2 binding to PD-1 restoring T-cell mediated tumor response. The Fc-hinge region has been engineered to preclude FcγR1 mediated binding to macrophages/myeloid-derived suppressor cells, a potential mechanism of PD-1 bound T-cell clearance. Regulatory Foxp3+ T-cells and PD-1+T-cell infiltration in the tumor microenvironment have been reported in HNSCC supporting the rationale for evaluation of BGB-A317 in pts with HNSCC. Here we present the preliminary results from a subset of pts with HNSCC treated with BGB-A317.


This ph 1, open-label, multi-center, dose-escalation/expansion study was conducted to evaluate the safety, tolerability, and anti-tumor activity of BGB-A317 in pts with advanced solid tumors. Pts with histologically confirmed advanced HNSCC who progressed following standard of care treatment were eligible to receive BGB-A317 administered at a dose of 5 mg/kg Q3W. Adverse events (AEs) were assessed per NCI-CTCAE v4.03. Tumor assessments were performed Q9W per RECIST v1.1.


As of 6 Mar 2017, 18 pts with recurrent HNSCC were enrolled (median age, 63 years [25-78]). Most pts were male (89%), Caucasian (67%) and had received ≥2 prior lines of anti-cancer treatment. The median treatment duration for BGB-A316 was 104 days (30-245); 7 pts remain on study. Most treatment-emergent AEs were Grade (Gr) 1/2 in severity and the more common AEs were fatigue (n = 6), constipation (n = 3) and ear discomfort (n = 3). Eleven unique AEs ≥Gr 3 were reported in 7 pts: dysphagia, nausea salivary gland enlargement, dyspnea, pleuritic pain, aspiration pneumonia, infection-related COPD exacerbation, parotitis, ocular hyperemia, and wound hemorrhage. A partial response (PR) has been confirmed in 1 pt, and 8 pts have stable disease (SD,) including 2 unconfirmed PRs. The disease control rate, defined as the proportion of pts who have achieved CR, PR and SD, is 50%.


BGB-A317 appears to be well tolerated in pts with recurrent HNSCC. The preliminary safety profile and anti-tumor activity support continued investigation of BGB-A317 in this setting.

Clinical trial identification

NCT02407990, March 26, 2015

Legal entity responsible for the study

Beigene Ltd.


Beigene Ltd.


L. Horvath: Clinical trials agreement with budget from Beigene, during the conduct of the study; J. Desai, S. Sandhu: Honoraria: Bayer, Merck Serono, Novartis. Consulting or advisory role: Amgen, Bayer, Bionomics, Circadian Technologies, Merck Serono, Norvartis. Research funding: GlaxoSmithKline (Inst), Roche-Genentech (Inst), Ventana Medical Systems (Inst). A.G. Hill: Research funding, Stock and Other Ownership Interests: Tasman Oncology. Travel Accommodations, Expenses: Bristol-Myers Squibb. B. Markman: Personal fees from Beigene during the conduct of the study. Z. Chen, J. Hou: Employee of BeiGene Ltd. X. Tan: Employee of BeiGene (Beijing) Co. Ltd. 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.