BRACAnalysis CDx® Companion Diagnostic Test Identifies Patients with Metastatic Pancreatic Cancer Who Benefited from Treatment with Lynparza® (olaparib)
SALT LAKE CITY, June 02, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in personalized medicine, today announced that its BRACAnalysis CDx® companion diagnostic test effectively identified patients with metastatic pancreatic cancer who benefitted from treatment with Lynparza® (olaparib) in the Phase III POLO study. Results of this important study were featured today at the 2019 American Society of Clinical Onocology (ASCO) meeting in Chicago.
“Our long-standing collaboration with Myriad Genetics Inc. has enabled us to deliver the positive POLO study in pancreatic cancer patients, demonstrating our shared ambition to target precision medicines to the right patients across different cancers,” said Ruth March, Ph.D., senior vice president and head of Precision Medicine, Oncology R&D, AstraZeneca.
Specifically, the POLO study demonstrated that patients with a germline mutation, and whose disease had not progressed on first-line platinum-based chemotherapy, had a clinically-meaningful and statistically-significant improvement in progression-free survival (PFS) of 7.4 months when treated with Lynparza® compared to 3.8 months for placebo (HR 0.53; p=0.004). Lynparza is a novel PARP inhibitor being commercialized by AstraZeneca (LSE/STO/NYSE: AZN) and Merck (known as MSD outside the U.S.) and is not currently approved by the U.S. Food and Drug Administration (FDA) for gBRCAm pancreatic cancer.
“The POLO study demonstrated the clinical effectiveness of the BRACAnalysis CDx test to identify germline BRCA mutations and enable transformative precision therapy for patients with pancreatic cancer,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. “The message for clinicians is clear: all patients with pancreatic cancer should receive a BRACAnalysis CDx test to determine their BRCA status.”
New NCCN Guidelines Recommend Genetic Testing for All Patients with Pancreatic Cancer In February, the National Comprehensive Cancer Network (NCCN) updated its guidelines to recommend universal germline BRCA testing for all patients with pancreatic cancer. Pancreatic cancer is the third most common cause of cancer-related death in the United States, and it is estimated that germline BRCA-mutated pancreatic cancer accounts for approximately seven percent of all cases.
“Based on the new NCCN guidelines, clinicians should order a BRACAnalysis CDx test for their patients with pancreatic cancer at the time of diagnosis,” said Dr. Lancaster. “The sooner we can identify patients with germline BRCA mutations, the better chance they will have to benefit from precision therapies.”
Myriad previously announced that it intends to file a supplementary Premarket Approval (sPMA) application with the FDA to authorize BRACAnalysis CDx as a companion diagnostic for Lynparza in patients with pancreatic cancer. The Company also has signed an exclusive commercialization agreement with AstraZeneca.
“We congratulate AstraZeneca and Merck on the POLO study results and look forward to collaborating with them to improve outcomes for patients with pancreatic cancer,” said Nicole Lambert, president, Myriad Oncology. “BRACAnalysis CDx is the only test approved by FDA to identify germline BRCA mutations, and the POLO study highlights our ongoing commitment to improve outcomes for people with difficult-to-treat cancers.”
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 germline BRCAm metastatic breast cancer who have been previously treated with chemotherapy and are eligible for treatment with Lynparza. -- January 2018: FDA approved BRACAnalysis CDx as a companion diagnostic to identify patients with germline BRCAm metastatic breast cancer who have been previously treated with chemotherapy and are eligible treatment with Lynparza. -- August 2017: FDA approved BRACAnalysis CDx as a complementary diagnostic to identify patients with recurrent platinum-sensitive germline BRCAm ovarian cancer who are eligible for maintenance treatment with Lynparza. -- 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.
Lynparza is a registered trademark of AstraZeneca.
Safe Harbor StatementThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the results of the POLO Study being reported at the 2019 ASCO meeting; the ability of the BRACAnalysis CDx test to identify patients with pancreatic cancer who may benefit from treatment with olaparib; the importance of the BRACAnalysis CDx test for this patient population and the ability to identify patients likely to benefit from PARP inhibition therapy; messaging to clinicians that all patients with pancreatic cancer should receive a BRACAnalysis CDx test to determine their BRCA status; clinicians ordering a BRACAnalysis CDx test for their patients with pancreatic cancer at the time of diagnosis based on NCCN guidelines; looking forward to collaborating with AstraZeneca and Merck to improve outcomes for patients with pancreatic cancer; and the Company’s strategic directives under the caption “About Myriad Genetics.” These “forward-looking statements” are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decision in the lawsuit brought against us by the Association for Molecular Pathology et al; risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading “Risk Factors” contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2018, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
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