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Clinical Trials

Date: 2014-11-20

Type of information: Presentation of results at a congress

phase:

Announcement: presentation of results at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain

Company: Myriad Genetics (USA - UT) Tesaro (USA - MA)

Product: myChoice HRD companion diagnostic and niraparib

Action mechanism:

  • Myriad's proprietary Homologous Recombination Deficiency (HRD) test detects DNA scars that indicative of a tumor that has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs. High HRD scores reflective of DNA repair deficiencies are prevalent in all breast cancer subtypes and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in triple-negative breast cancer patients.
  • Niraparib is an orally active and potent poly (ADP-ribose) polymerase, or PARP, inhibitor. A Phase 1/2 monotherapy study of niraparib has been completed in more than 100 patients with advanced solid tumors. Two Phase 3 trials are currently ongoing to evaluate a single oral dose of niraparib as a maintenance therapy for patients with ovarian cancer and as a treatment for patients with BRCA-positive breast cancer.

Disease: ovarian cancer

Therapeutic area: Cancer - Oncology - Diagnostic

Country:

Trial details:

Latest news:

  • • On November 20, 2014, Tesaro and Myriad Genetics described new data demonstrating that Myriad\'s myChoice HRD™ score is predictive of niraparib sensitivity in patient-derived xenograft models of ovarian cancer. These results were presented by Dr. Paul Haluska, Jr., M.D., Ph.D., Associate Professor of Oncology at the Mayo Clinic, at the 26th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona, Spain.
  • Patient-derived xenografts were created from more than 100 high grade serious ovarian cancer tumor samples. HRD testing was performed on each sample using myChoice HRD to define HRD status, detect BRCA 1 and 2 mutations and identify hypermethylation of BRCA genes. Approximately half of these models were HRD positive and are being evaluated for sensitivity to niraparib in vivo. Preliminary data from treated models indicate all models that responded to niraparib treatment had an HRD score above the predetermined cutoff value and included both BRCA mutant and BRCA wild type tumors. Evaluation of niraparib sensitivity across the full set of selected models is ongoing. These initial results indicate that identifying patients with homologous recombination deficiencies using myChoice HRD may help to identify patients who are most likely to respond to treatment with niraparib.

Is general: Yes