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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

1039 - The Safety and Efficacy of Durvalumab in Combination with Paclitaxel for the treatment of Metastatic Triple Negative Breast Cancer

Date

20 Oct 2018

Session

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

Topics

Immunotherapy

Tumour Site

Breast Cancer

Presenters

Hazem Ghebeh

Citation

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

Authors

H. Ghebeh1, A.D. Alsayed2, K. Suleman2, T. Al-Tweigeri2

Author affiliations

  • 1 Stem Cell & Tissue Re-engineering Program, King Faisal Specialist Hospital and Research Center, 11211 - Riyadh/SA
  • 2 Oncology Centre, King Faisal Specialist Hospital and Research Center, 11211 - Riyadh/SA
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Resources

Abstract 1039

Background

Metastatic triple negative breast cancer has poor prognosis and limited treatment options. Immunotherapy with anti-PD-L1 monoclonal antibodies has shown promising results in several types of cancer including triple negative breast cancer. We have initiated a clinical trial to test the safety and efficacy of a combination of the investigational anti-PD-L1 monoclonal antibody durvalumab and paclitaxel for the treatment of metastatic breast cancer. The rationale behind this trial is that treatment with paclitaxel correlates with development of tumor infiltrating lymphocytes (Demaria et al. 2001; Sardella et al. 2006), and the upregulation of PD-L1 on tumor cells. On the other hand, response to targeted anti-PD-L1 therapy correlates with the level of expression of PD-L1 on tumor cells and the pre-existing tumor immunity like CD8+ infiltrating cells and type I helper CD4+ activated lymphocytes (Herbst, Soria et al. 2014). In addition, PD-L1 has anti-apoptotic function that its blockade will synergize with the apoptotic effect of chemotherapeutic agents like paclitaxel. Therefore, the combination of these two agents is likely to be synergistic.

Trial design

The treatment is designed to start with one cycle of paclitaxel alone to enhance the immunogenicity and immune cell infiltration followed by the combination of the two agents. Paclitaxel will be delivered weekly on days 1, 8 and 15 of each 28 days cycle while Durvalumab will be given every two weeks (Days 1 and 15 of each cycle). Paclitaxel is given for 6 cycles only while Durvalumab is given until disease progression, or unacceptable toxicity. The primary endpoint of the study is to measure safety and tolerability of the combination while the secondary endpoints include efficacy monitoring.

Clinical trial identification

Legal entity responsible for the study

T. Al‐Tweigeri, M.D.

Funding

This clinical trial is an investigator-initiated trial sponsored partially by AstraZeneca as an externally sponsored research (ESR 14 10649).

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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