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Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

1543 - A phase Ib/II study of Durvalumab combined with dose-dense EC in neoadjuvant setting for patients with locally advanced luminal B HER2(-) or triple negative breast cancers (B-IMMUNE).

Date

22 Oct 2018

Session

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

Presenters

Alix Devaux

Citation

Annals of Oncology (2018) 29 (suppl_8): viii87-viii89. 10.1093/annonc/mdy271

Authors

A. Devaux1, J. Canon2, F.P. Duhoux3, P. Delrée4, C. Galant5, P.G. Coulie1, I. Bar4, M. Constant4, S. Haussy4, O. Bricard1, K. Missault1, M. Berlière6, T. Willems7, J. Carrasco2

Author affiliations

  • 1 Gece Unit, de Duve Institute, UCL, 1200 - Brussels/BE
  • 2 Oncology, Grand Hopital de Charleroi Site Notre Dame, 6000 - Charleroi/BE
  • 3 Medical Oncology, King Albert II Cancer Institute, Cliniques universitaires Saint-Luc, 1200 - Brussels/BE
  • 4 Laboratoire D'oncologie Translationnelle, Grand Hopital de Charleroi/Institut de Pathologie et Génétique, 6041 - Gosselies/BE
  • 5 Pathology, Cliniques universitaires Saint-Luc, 1200 - Brussels/BE
  • 6 Gynecology, Cliniques Universitaires Saint-Luc, 1200 - Brussels/BE
  • 7 Gynecology, Grand Hopital de Charleroi Site Notre Dame, 6000 - Charleroi/BE
More

Resources

Abstract 1543

Background

Most patients with advanced breast cancer (BC) do not respond to immunotherapy with immunostimulating antibodies. Breast tumours are considered poorly antigenic due to a low mutational load, yet they contain tumour-infiltrating lymphocytes (TILs). As continuous immune pressure selects tumours that escape immune destruction, there is growing interest for the use of immunostimulatory antibodies for early-stage cancers. Based on data suggesting that anthracyclines increase tumour immunogenicity, we initiated a phase Ib/II trial to study the safety and efficacy of the anti-PD-L1 antibody durvalumab combined to epirubicin in the neoadjuvant setting for localized BC.

Trial design

B-IMMUNE study is a multicentric prospective trial including luminal B HER2(-) and triple negative BC (TNBC) patients. The study includes two parts. First a phase Ib with a 3 + 3 design whose primary objective is to evaluate the safety of an increasing number of durvalumab infusions associated to dose-dense Epirubicin-Cyclophosphamide (EC) after weekly paclitaxel for 12 weeks in the neoadjuvant setting. Then, if the durvalumab-EC combination is safe, a phase II will be initiated with an open-label 4:1 randomization in favour of the experimental durvalumab arm. Its primary objective is to evaluate clinical efficacy based on the complete pathological response rate (pCR) compared to historical controls (15% for luminal B HER2(-) BC and 30% for TNBC). The phase II will include 24 luminal B HER2(-) BC patients and 22 TNBC patients, allowing to detect pCR rate improvements of 40% and 60%, respectively (α ≤ 0.1 and β ≤ 0.1). Exploratory objectives include the identification of predictive biomarkers for anti-PD-L1 efficacy with a focus on the TCR repertoires of tumour-infiltrating T cells collected before and after durvalumab. Translational research will evaluate the presence of tumour-specific CD8 T cells among TILs and the influence of durvalumab on this population using the control arm as a reference.

Clinical trial identification

NTC03356860, ONCOGHdC2015_01, November 29, 2017.

Legal entity responsible for the study

Grand Hôpital de Charleroi (GHdC).

Funding

AstraZeneca, Télévie (FNRS).

Editorial Acknowledgement

Disclosure

J. Carrasco: Research grant: AstraZeneca. All other authors have declared no conflicts of interest.

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