SALT LAKE CITY, Feb. 26, 2019 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in personalized medicine, today announced that the Phase III POLO study demonstrated its BRACAnalysis CDx® test successfully identified patients with metastatic pancreatic cancer who have BRCA mutations and benefitted from treatment with olaparib, a novel PARP inhibitor. Myriad plans to file a supplementary Premarket Approval (sPMA) application with the U.S. Food and Drug Administration (FDA) to authorize BRCAnalysis CDx as a companion diagnostic for olaparib in this indication and has an exclusive commercialization agreement.
“The results of the POLO trial strongly support use of the BRACAnalysis CDx test to help inform treatment decisions in the metastatic pancreatic 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 Genetics. “This study underscores Myriad’s commitment to our pharmaceutical partners and to advancing the field of personalized medicine for patients with cancer.”
The topline results – announced earlier today by AstraZeneca and MSD Inc. – are the first reported clinical data from the POLO study (NCT02184195), which assessed the efficacy of olaparib as first-line maintenance monotherapy in patients with germline BRCA-mutated, metastatic pancreatic cancer whose disease had not progressed on platinum-based chemotherapy. The results demonstrated a statistically-significant and clinically-meaningful improvement of progression-free survival (PFS) among BRCA-mutated patients treated with olaparib compared to placebo.
“We congratulate AstraZeneca and Merck on these exciting study results and are excited to expand the use of BRACAnalysis CDx in this patient population,” said Nicole Lambert, general manager, Myriad Oncology. “Data from multiple clinical studies have consistently shown that BRACAnalysis CDx can accurately identify patients for treatment with multiple PARP inhibitors.” BRACAnalysis CDx is the only FDA-approved germline BRCA1/2 test.
It is estimated there were 466,000 new cases of pancreatic cancer diagnosed globally in 2018. Germline BRCA-mutated pancreatic cancer accounts for five to seven percent of all cases. Pancreatic cancer is the fourth leading cause of cancer death, and less than seven percent of patients survive more than five years after diagnosis. Approximately 80 percent of patients are diagnosed at the metastatic stage.
Olaparib is being commercialized by AstraZeneca and MSD Inc. (MSD: known as Merck & Co., Inc. inside the US and Canada). The collaboration between Myriad and AstraZeneca on olaparib began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx.
- December 2018: FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients newly diagnosed with advanced ovarian cancer who are eligible for first-line maintenance treatment with olaparib.
- March 2018: The Japanese Ministry of Health, Labour, and Welfare approved BRACAnalysis CDx as a companion diagnostic to identify patients with metastatic breast cancer who are eligible for second-line treatment with olaparib.
- January 2018: FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients with metastatic breast cancer who are eligible for second-line treatment with olaparib.
- August 2017: FDA approved BRACAnalysis CDx as a complementary diagnostic to identify patients with ovarian cancer who are eligible for second-line treatment with olaparib.
- Dec. 2014: FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients with advanced ovarian cancer who are eligible for fourth-line treatment with olaparib.
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. 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. Learn more at: http://myriadmychoice.com/.
About Myriad Genetics
Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on five strategic imperatives: build upon a solid hereditary cancer foundation, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020. For more information on how Myriad is making a difference, please visit the Company’s website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore, Prolaris, ForeSight and Prequel are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.