In a recent study, the myChoice HRD test from Myriad Genetics Inc, Salt Lake City, identified an increased number of patients with ovarian cancer who may benefit from treatment with niraparib. Niraparib is an investigational oral poly ADP ribose polymerase (PARP) inhibitor being developed by Tesaro Inc, Waltham, Mass.
The NOVA study (NCT01847274) evaluated the safety and efficacy of niraparib as a maintenance therapy in more than 500 patients with recurrent ovarian cancer. The primary outcome was the prolongation of progression-free survival (PFS). Patients were divided into two groups: those with a germline BRCA mutation and those without. Patients without a germline BRCA mutation were evaluated for homologous recombination deficiency (HRD) using Myriad’s myChoice HRD test. Patients in both groups were randomized to receive niraparib or placebo.
The study demonstrated that the myChoice HRD test approximately doubled the number of patients who may benefit from niraparib treatment over the number identified by another FDA-approved test. Patients who were germline BRCA negative, but myChoice HRD positive, experienced over a threefold increase in median PFS with niraparib compared to placebo.
Mark C. Capone, Myriad Genetic Laboratories.
“We are very excited about these strong clinical findings, as they demonstrate a new paradigm to personalize PARP inhibitor treatment,” says Mark Capone, president and CEO of Myriad Genetics. “We believe the myChoice HRD test is positioned to become the gold standard companion diagnostic for PARP inhibitors, and will help physicians confidently select safe and effective treatment plans for their patients.”
Myriad’s myChoice HRD test is a comprehensive homologous recombination deficiency test to detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. The myChoice HRD score is a composite of three proprietary technologies: loss of heterozygosity, telomeric allelic imbalance, and large-scale state transitions. Positive myChoice HRD scores, reflective of DNA repair deficiencies, are prevalent in all breast cancer subtypes, as well as in ovarian and most other major cancers.
In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.4 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents.
The myChoice HRD test is being developed in parallel with the clinical development of niraparib. The collaboration with Tesaro began in March 2014, and includes several ongoing clinical trials in a variety of tumor types.
For more information, visit Myriad.
