388P - Preliminary results from a subset of patients (pts) with advanced head and neck squamous carcinoma (HNSCC) in a dose-escalation and dose-expansion...

Date 11 September 2017
Event ESMO 2017 Congress
Session Poster display session
Topics Drug Development
Cancer Immunology and Immunotherapy
Head and Neck Cancers
Presenter Lisa Horvath
Citation Annals of Oncology (2017) 28 (suppl_5): v122-v141. 10.1093/annonc/mdx367
Authors 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
  • 1Medical Oncology, Chris O’Brien Lifehouse, 2050 - Camperdown/AU
  • 2Medical Oncology, Peter MacCallum Cancer Centre, 3000 - Melbourne/AU
  • 3Department Of Oncology, Peter MacCallum Cancer Center, 3002 - Melbourne/AU
  • 4Endocrine, Diabetes & Research Centre, Wellington Hospital, Wellington/NZ
  • 5Medical Oncology, Tasman Oncology Research, Southport/AU
  • 6Internal Medicine, Auckland City Hospital, Auckland/NZ
  • 7Department Of Oncology, Monash Cancer Center, Monash Health, 3168 - Melbourne/AU
  • 8Regional Cancer Center, Waikato Hospital, 3240 - Hamilton/NZ
  • 9Oncology, BeiGene (Beijing) Co. Ltd, Beijing/CN
  • 10Immunoncology, BeiGene USA, Inc, Emeryville/US
  • 11Oncology, Linear Clinical Research, Nedlands/AU

Abstract

Background

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.

Methods

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.

Results

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%.

Conclusions

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.

Funding

Beigene Ltd.

Disclosure

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.