APR 12, 2017 10:30 AM PDT

Prediction of enzalutamide sensitivity in triple negative breast cancer

SPONSORED BY: NanoString Technologies
C.E. CREDITS: P.A.C.E. CE | Florida CE
Speakers
  • Director, Bioinfomatics, Associate Professor, University of North Carolina, Chapel Hill
    Biography
      Dr. Parker's research is focused in the methodological development and integrated analysis of high throughput genetic and genomic studies. He previously lead the development of algorithms and content resulting in ProsignaTM, the only CE marked and FDA 510(k) cleared breast cancer diagnostic assay for FFPE tissue. He is currently involved in similar diagnostic development in kidney and bladder cancer, and recently presented a novel predictive biomarker for enzalutamide in triple negative breast cancer which is being used as entry criteria for a phase III trial. Dr. Parker currently directs the sequencing, microarray, and other genomics analysis in the Bioinformatics Shared Resource at the Lineberger Comprehensive Cancer Center. The impact of his collaborative efforts are demonstrated in publications, which presently constitute >150 peer review publications.

    Abstract:

    A recent clinical trial of the AR inhibitor enzalutamide in patients with TNBC included an exploratory endpoint using RNA sequencing to identify a genomic signature of patients likely to respond to treatment. Tumor samples were collected from all patients enrolled in the single-arm, open-label phase 2 trial. The primary endpoint was clinical benefit rate at 16 weeks (CBR16). Samples were assayed by whole transcriptome RNA-sequencing and divided into a training and blinded validation cohort for model development and evaluation. The gene expression model of enzalutamide sensitivity demonstrated strong association with progression free survival (HR = 0.40, Wald p = 0.0001).  This signature is being used to select patients enrolling in a phase 3 trial of enzalutamide in patients with advanced TNBC. Biological associations and translation of the assay for clinical use will highlighted.


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