Myriad Will Seek FDA Approval of BRACAnalysis CDx® As a Companion Diagnostic for Lynparza® (olaparib) In Men with Metastatic Castrate-Resistant Prostate Cancer
SALT LAKE CITY, Aug. 7, 2019 – Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in molecular diagnostics, today announced that the AstraZeneca/Merck Phase III PROfound study (NCT02987543) met its primary endpoint and demonstrated that men with metastatic castration-resistant prostate (mCRPC) cancer selected for BRCA1/2 or ATM gene mutations, a subpopulation of homologous recombination repair gene mutations, lived for longer time without disease progression when treated with Lynparza® (olaparib), a novel PARP inhibitor. Myriad will file a supplementary Premarket Approval Application (sPMA) with the U.S. Food and Drug Administration (FDA) to authorize BRACAnalysis CDx as a companion diagnostic test for olaparib in mCRPC patients with germline BRCA mutations.
“The PROfound trial confirmed the potential benefits of using biomarkers to help guide care for men with metastatic castration-resistant prostate cancer,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. “This study is another example of Myriad’s commitment to help our pharmaceutical partners achieve and deliver precision medicine for people with cancer.”
The topline results – announced earlier today by AstraZeneca (LSE/STO/NYSE: AZN) and Merck – are the first reported clinical results from the PROfound study, which assessed the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations. The results demonstrated a statistically-significant and clinically-meaningful improvement of radiographic progression-free survival among patients selected for mutations in BRCA1/2 or ATM and were treated with olaparib.
“We congratulate AstraZeneca and Merck on the successful completion of the PROfound trial and look forward to expanding the population of people who can potentially benefit from testing with BRACAnalysis CDx,” said Nicole Lambert, president, Myriad Oncology. “Importantly, this study is another example of Myriad’s commitment to leverage our portfolio of tumor and germline tests to develop and deliver precision medicine for people with cancer.”
It is estimated there are more than 170,000 men are diagnosed with prostate cancer each year. Prostate cancer is the second leading cause of death by cancer in men, and it is estimated that 31,620 deaths from this disease will occur this year. The updated 2019 National Comprehensive Cancer Network (NCCN) Guidelines® state that germline BRCA mutations should be tested in all newly-diagnosed men with NCCN high-risk, very high-risk, regional or metastatic prostate cancer.
The collaboration between Myriad and AstraZeneca on olaparib began in 2007 and has resulted in multiple regulatory approvals for BRACAnalysis CDx.
- February 2019: The Japanese Ministry of Health, Labour, and Welfare approved BRACAnalysis CDx as a companion diagnostic to identify women with ovarian cancer who have a germline BRCA mutation and are eligible for first-line maintenance therapy with Lynparza.
- 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 Lynparza.
- 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 Lynparza.
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. Click here to learn more.
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 Myriad 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 Statement
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Company filing an sPMA application with the U.S. FDA to authorize BRACAnalysis CDx as a companion diagnostic test for olaparib in mCRPC; expanding the population of people who can potentially benefit from testing with BRACAnalysis CDx; better outcomes for men with mCRPC; 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.