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Tesaro Using Myriad HRD Test in Investigational PARP Inhibitor Studies

NEW YORK (GenomeWeb News) – Tesaro will use Myriad Genetics' Homologous Recombination Deficiency (HRD) test to identify best responders to its investigational PARP inhibitor, niraparib, Myriad said today.

Tesaro is already using Myriad's BRACAnalysis test to identify responders in two Phase III clinical trials involving niraparib: one in platinum-sensitive, high-grade serous ovarian cancer patients and a second in metastatic breast cancer patients who have germline BRCA mutations. Both studies were slated to begin last year.

Now Tesaro has decided to also test out the next-generation sequencing-based HRD diagnostic in niraparib studies, a strategy that BioMarin and PharmaMar have also employed for their drug candidates. Overall, this is Myriad's fifth collaboration with a drug developer to use the HRD test in clinical trials of investigational agents.

"Prior studies have shown that only a subset of patients will respond to PARP inhibitors. HRD is the most comprehensive test to identify those patients who might respond to treatment," Myriad CSO Jerry Lanchbury said in a statement. "We believe using the HRD test may capture an enhanced number of responders to treatment with … PARP inhibitors."

The HRD test assesses not just germline BRCA1/2 gene mutations like BRACAnalysis does, but also somatic BRCA mutations and a number of other markers involved in DNA repair. The test provides three scores based on whole-genome tumor loss of heterozygosity (LOH) profiles, telomeric allelic imbalance (TAI), and large-scale state transitions (LST), that studies suggest can predict which patients will respond well to certain oncologics.

Myriad is hoping to commercially launch the HRD test for platinum therapies in 2015 and for PARP inhibitors in 2017.