On February 17, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported new findings from the OlympiAD study that show its BRACAnalysis CDx test successfully identified patients with HER2-negative metastatic breast cancer who have BRCA mutations and who had improved response with Lynparza (olaparib), AstraZeneca’s PARP inhibitor (Press release, Myriad Genetics, FEB 17, 2017, View Source [SID1234517753]).

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The high level results — announced earlier today from AstraZeneca — are the first reported clinical data from the OlympiAD study (NCT02000622), which assessed the efficacy and safety of olaparib monotherapy versus physicians’ choice of chemotherapy (i.e., capecitabine, vinorelbine or eribulin) in the treatment of metastatic breast cancer. Of the 302 patients in the study, 98 percent (297/302) tested positive for germline BRCA1/2 mutations as determined by Myriad’s FDA-approved BRACAnalysis CDx test. The results demonstrated a statistically-significant improvement of progression-free survival (PFS) among BRCA-mutated patients treated with olaparib compared to those treated with physicians’ choice.

"We believe the results of the OlympiAD trial support use of the BRACAnalysis CDx test to help inform treatment decisions in the metastatic breast cancer setting and will expand the patient population who can benefit from BRCA testing," said Johnathan Lancaster, M.D., Ph.D., chief medical officer of Myriad Genetic Laboratories. "This study underscores Myriad’s commitment to our pharmaceutical partners and to advancing the field of personalized medicine so that new effective treatment options are available to patients."

It is estimated there are approximately 60,000 patients with metastatic breast cancer, two thirds of whom are not currently eligible for BRCA testing based upon family and personal history alone or current testing criteria. If approved as a new indication this would triple the number of patients with metastatic breast cancer who would benefit from BRCA testing.

The ongoing collaboration between Myriad and AstraZeneca to develop a novel companion diagnostic test to identify candidates for treatment with olaparib began in 2007. In Dec. 2014, Myriad received FDA approval for BRACAnalysis CDx to help identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib. BRACAnalysis CDx is Myriad’s first FDA-approved companion diagnostic and was the first-ever laboratory developed test reviewed and approved by the FDA.

About BRACAnalysis CDx
BRACAnalysis CDx is an in vitro diagnostic device intended for the qualitative detection and classification of variants in the protein coding regions and intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic DNA obtained from whole blood specimens collected in EDTA. Single nucleotide variants and small insertions and deletions (indels) are identified by polymerase chain reaction (PCR) and Sanger sequencing. Large deletions and duplications in BRCA1 and BRCA2 are detected using multiplex PCR. Results of the test are used as an aid in identifying ovarian cancer patients with deleterious or suspected deleterious germline BRCA variants eligible for treatment with Lynparza (olaparib). This assay is for professional use only and is to be performed only at Myriad Genetic Laboratories, a single laboratory site located at 320 Wakara Way, Salt Lake City, UT 84108.

About Lynparza
Lynparza (olaparib) is an innovative, first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that may exploit tumour DNA damage response (DDR) pathway deficiencies to preferentially kill cancer cells. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of compounds targeting DNA damage response (DDR) mechanisms in cancer cells. Lynparza is currently approved by regulatory health authorities in the EU for use as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy. It is also approved in the US as monotherapy in patients with deleterious or suspected deleterious germline BRCA-mutated (as detected by an FDA-
test) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. Lynparza is currently being investigated in another separate non-metastatic breast cancer Phase III study called OLYMPIA. This study is still open and recruiting patients internationally.