Myriad Genetics (MYGN) Announces Strong Data from myChoice HRD Test in Ovarian Cancer (TSRO)

October 10, 2016 6:54 AM EDT

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Myriad Genetics, Inc. (Nasdaq: MYGN) announced that its myChoice HRD test identified more than double the number of patients who may benefit from treatment with niraparib than were identified by germline BRCA testing alone. The myChoice HRD test was evaluated in the NOVA study (NCT01847274) of nirarapib, an investigational oral PARP inhibitor being developed by TESARO (Nasdaq: TSRO).

Today’s announcement follows publication of the NOVA study in the New England Journal of Medicine. NOVA is a well-controlled Phase 3 trial of niraparib that enrolled 553 patients with recurrent ovarian cancer who responded to their most recent platinum-based chemotherapy. This trial was designed to assess progression free survival (PFS) in a broad population of patients who were assigned to one of two cohorts based upon germline BRCA mutation status.

“Patients with ovarian cancer who tested positive with myChoice HRD experienced a clinically meaningful improvement in PFS,” said Johnathan Lancaster, M.D., Ph.D., gynecologic oncologist and chief medical officer of Myriad Genetic Laboratories. “We estimate that myChoice HRD identifies more than double the number of patients who may benefit compared to germline BRCA testing alone.”

The NOVA results showed that in patients who were germline BRCA mutation carriers, the median PFS for patients treated with niraparib was 21.0 months compared to 5.5 months for the control group (p<0.0001; HR 0.27,95% CI, 0.173-0.410). The median PFS benefit for patients with HRD-positive tumors who were treated with niraparib was 12.9 months compared to 3.8 months for the control group (P<0.0001; HR 0.38, 95% CI, 0.243-0.586). Additionally, the exploratory analysis showed that for patients who were determined to be HRD negative, the median PFS for patients treated with niraparib was 6.9 months compared to 3.8 months for the control group (p<0.0226; HR 0.58, 95% CI, 0.361-0.922).

The key findings are illustrated in the chart below. http://www.globenewswire.com/NewsRoom/AttachmentNg/e05f7572-2d8d-48c8-80b4-4a2ad412e9db

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.



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