AZ to Use Myriad's myChoice HRD Plus Test in Phase III Trial

January 3, 2018
AZ to Use Myriad's myChoice HRD Plus Test in Phase III Trial
Myriad Genetics' myChoice HRD Plus test will be used by AstraZeneca in an exploratory analysis to identify women with advanced ovarian cancer who may benefit from maintenance treatment with a combination of AZ’s Lynparza® (olaparib) and the Genentech (Roche) cancer drug Avastin® (bevacizumab). [Source: OGphoto / Getty Images]

Myriad Genetics said today that its myChoice HRD Plus test will be used by AstraZeneca in an exploratory analysis to identify women with advanced ovarian cancer who may benefit from maintenance treatment with a combination of AZ’s Lynparza (olaparib) and the Genentech (Roche) cancer drug Avastin® (bevacizumab).

The value of the collaboration—an expanded research partnership with AstraZeneca—was not disclosed.

Myriad said it will use myChoice HRD Plus to evaluate patients enrolled in an ongoing Phase III trial, with the goal of identifying cases with homologous recombination deficiencies (HRD).

myChoice HRD Plus is a homologous recombination deficiency test designed 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. myChoice HRD Plus is a composite of three proprietary technologies—loss of heterozygosity, telomeric allelic imbalance and large-scale state transitions—and up to 90 other genes and molecular markers including microsatellite instability associated with DNA repair pathways.

“We are optimistic that myChoice HRD Plus will identify more women with ovarian cancer who could benefit from therapy with Lynparza than previous tests that only identify germline BRCA1/2 mutations,” Myriad CSO Jerry Lanchbury, Ph.D., said in a statement.

Since 2007, Myriad and AstraZeneca have carried out an ongoing collaboration to develop a novel companion diagnostic test to identify candidates for treatment with olaparib. In December 2014, Myriad won FDA approval for BRACAnalysis CDx, a BRCA1 and BRCA2 diagnostic test designed to identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with Lynparza. 

BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic and was the first-ever laboratory developed test approved by the FDA.

The first FDA-approved poly (ADP-ribose) polymerase (PARP) inhibitor upon its authorization by the FDA in 2014, Lynparza is indicated in part as a maintenance treatment for adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. Lynparza is also indicated for adults with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

Patients are selected for therapy based on Myriad’s FDA-approved companion diagnostic. AstraZeneca is one of four PARP inhibitor developers, along with BeiGene, Clovis Oncology, and Tesaro. Myriad has launched companion diagnostics collaborations with all four developers of PARP inhibitors.

Lynparza is being co-developed and co-commercialized by AstraZeneca and Merck & Co. through a global strategic oncology collaboration launched in July 2017.