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Poster display session

2099 - Preliminary results from a subset of patients (pts) with advanced ovarian cancer (OC) in a dose-escalation/expansion study of BGB-A317, an anti-PD-1 monoclonal antibody (mAb)

Date

11 Sep 2017

Session

Poster display session

Presenters

Tarek Meniawy

Citation

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

Authors

T. Meniawy1, G. Richardson2, A. Townsend3, J. Desai4, H. Gan5, M. Friedlander6, L. Horvath7, M.B. Jameson8, S. Sandhu9, Z. Wu10, Z. Qin11, K. Kang12, B. Markman13

Author affiliations

  • 1 Oncology, Linear Clinical Research Limited, 6009 - Nedlands/AU
  • 2 Haemotology & Oncology Services, Cabrini Hospital Malvern, Cabrini Hospital Malvern/AU
  • 3 Haematology/oncology, Queen Elizabeth Hospital, 5011 - Woodville/AU
  • 4 Medical Oncology, Peter MacCallum Cancer Centre, 3000 - Melbourne/AU
  • 5 Austin Hospital, Olivia Newton-John Cancer Research Institute, 3084 - Heidelberg/AU
  • 6 Medical Oncology, Prince of Wales Hospital, Randwick/AU
  • 7 Medical Oncology, Chris O’Brien Lifehouse, Camperdown/AU
  • 8 Regional Cancer Center, Waikato Hospital, 3240 - Hamilton/NZ
  • 9 Oncology, Peter MacCallum Cancer Center, 3002 - Melbourne/AU
  • 10 Clinical Research, BeiGene USA, Inc, Fort Lee/US
  • 11 Clinical Research, BeiGene (Beijing) Co. Ltd, Beijing/CN
  • 12 Clinical Development, BeiGene (Beijing) Co. Ltd, Beijing/CN
  • 13 Department Of Oncology, Monash Cancer Center, Monash Health, 3168 - Melbourne/AU
More

Resources

Abstract 2099

Background

BGB-A317 is a humanized IgG4 anti-PD-1 mAb that blocks PD-L1/L2 binding to PD-1 restoring T-cell-mediated tumor inhibition. The Fc-hinge region has been engineered to preclude FcγR1 mediated binding to macrophages/myeloid-derived suppressor cells (MDSCs). Upregulation of PD-1/L1 and predominance of macrophages and MDSCs have been reported in OC supporting the rationale of evaluating BGB-A317 in pts with OC.

Methods

An open-label, multi-center, dose-escalation/expansion study is being conducted to evaluate the safety, tolerability and anti-tumor activity of BGB-A317 in pts with advanced solid tumors. Pts with histologically confirmed advanced OC were eligible and treated at different dose levels (0.5, 2, 5, 10 mg/kg intravenously [IV] every 2 weeks [Q2W] in dose escalation, or at 2 or 5 mg/kg IV Q2W or Q3W, or 200 mg IV Q3W in dose expansion, or 5 mg/kg IV Q3W in indication expansion). Tumor assessments, including CA125, occurred approximately every 2 months and response was collected according to both RECIST 1.1 and GCIG criteria. Adverse events (AEs) were assessed per NCI-CTCAE v4.03.

Results

As of 6 Mar 2017, 51 pts [median age 62 (19–80) yrs] with recurrent/refractory OC were enrolled. Most pts were Caucasian (88%), all had received ≥1 prior line of anti-cancer treatment (median 3 [1–12]). Median duration of treatment was 68 (22–446) days; 7 pts remain on study. The most common treatment-emergent AEs were nausea (37%), fatigue (28%), and abdominal pain (28%). 49% of pts experienced an AE ≥Grade (Gr) 3; stomatitis (n = 1) and diarrhoea (n = 1) were Gr 3 AEs considered treatment-related by investigators. Mucosal inflammation, pyrexia and colitis were serious AEs considered treatment-related by investigators (n = 1, each). Among 51 evaluable pts, the disease control rate is 43%; 2 PRs have been reported including 1 pt who remains on study and to date has achieved an 89% reduction in target lesions.

Conclusions

BGB-A317 appears to be generally well tolerated in pts with recurrent/refractory OC. The preliminary safety profile and anti-tumor activity are consistent with that observed with other checkpoint inhibitors and support continued investigation of BGB-A317.

Clinical trial identification

NCT02407990, March 26, 2015

Legal entity responsible for the study

Beigene Ltd.

Funding

Beigene Ltd

Disclosure

T. Meniawy: Non-financial support and other from BeiGene during the conduct of the study; Non-financial support from Bristol-Myers Squibb outside the submitted work. J. Desai: 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). L. Horvath: Clinical trial agreement with budget from Beigene, during the conduct of the study; S. Sandhu: Honoraria: Bristol-Myers Squibb, Merck. Consulting or Advisory: Amgen. Z. Wu: Employee of Beigene USA, Inc. Z. Qin, K. Kang: Employee of BeiGene (Beijing) Co. Ltd. B. Markman: Personal fees from Beigene during the conduct of the study. All other authors have declared no conflicts of interest.

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