On June 4, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported that its BRACAnalysis CDx companion diagnostic test successfully identified BRCA-mutated patients with HER2- metastatic breast cancer in the OlympiAD trial (NCT02000622) who responded better to treatment with olaparib than standard chemotherapy (Press release, Myriad Genetics, JUN 4, 2017, View Source [SID1234519454]).
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OlympiAD compared olaparib (300mg twice daily) to physician’s choice of a standard chemotherapy (capecitabine, vinorelbine or eribulin) in the treatment of 302 patients with HER2-negative metastatic breast cancer harboring germline BRCA1/2 mutations as determined by Myriad’s BRACAnalysis CDx companion diagnostic test. The results showed that BRCA-positive patients treated with olaparib had a statistically-significant and clinically-meaningful PFS benefit of compared to the control group.
"In this study, patients with BRCA mutations experienced significantly prolonged PFS when treated with olaparib versus standard of care chemotherapy," said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic Laboratories. "Based on these findings, all patients with metastatic breast cancer should know their BRCA status as it will be a critical factor in guiding therapy selection for patients with metastatic breast cancer."
It is estimated there are approximately 60,000 patients per year in the United States who are newly diagnosed with or progress to HER2- metastatic breast cancer. Of these patients, two-thirds are not eligible for BRCA testing based upon current testing criteria. If approved by the FDA as a new indication this would potentially triple the number of patients with metastatic breast cancer who are candidates for BRCA testing.
"We believe the results from the OlympiAD study will expand the population who can benefit from the BRACAnalysis CDx test, and the results will help doctors improve care for their patients with metastatic breast cancer," said Lancaster. "This study further supports the use of advanced biomarkers, like BRACAnalysis CDx, to enable precision medicine, which benefits both patients and the healthcare ecosystem."
The collaboration between Myriad and AstraZeneca to develop a novel companion diagnostic test for olaparib began in 2007. OlympiAD is the first Phase 3 trial to demonstrate the clinical utility of the BRACAnalysis CDx test outside of ovarian cancer for which the test was approved by the U.S. Food and Drug Administration (FDA) in Dec. 2014. Based on the robustness of the OlympiaAD results, Myriad plans to submit a supplementary premarket approval (sPMA) application under its existing PMA for BRACAnalysis CDx to include the HER2- metastatic breast cancer indication.
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, who are or may become eligible for treatment with Lynparza (olaparib). This assay is for professional use only and is to be performed only 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.