EndoPredict® Predicts the Chemotherapy Benefit in Women with Early ER-positive, HER2-negative Breast Cancer
New Study Finds Many Women May Receive Unnecessary Chemotherapy Treatment
SALT LAKE CITY, April 30, 2019 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced an international team of cancer researchers has found that EndoPredict® test accurately predicts which women with ER-positive, HER2-negative breast cancer will benefit from adjuvant chemotherapy. Findings from the study were published today in the journal Breast Cancer Research and Treatment.
"We are excited to publish our findings because ER-positive, HER2-negative breast cancer is the most common type of breast cancer, and a key goal is identifying which women need endocrine therapy alone and which need endocrine therapy plus chemotherapy to get the best possible outcomes,” said William J. Gradishar, M.D., one of the study’s authors and chief of hematology and oncology, department of medicine, Betsy Bramsen Professorship of Breast Oncology, and professor of medicine at Northwestern University's Feinberg School of Medicine. “Our study demonstrated that the EndoPredict test can accurately identify patients who are likely to benefit from adjuvant chemotherapy. What this means is that clinicians can use the EndoPredict test to personalize their care by directing chemotherapy to women with a high likelihood of benefit, while preventing the over-treatment of women who are unlikely to benefit.”
This study evaluated the ability of the EndoPredict test (EPclin) to predict chemotherapy benefit based on the analysis of the 10-year distant recurrence rate (i.e., metastasized cancer) in women with ER-positive, HER2-negative breast cancer who received five years of endocrine therapy (ET) alone or in combination with chemotherapy (ET+C). Data from 3,746 women (2,630 on ET alone and 1,116 on ET+C) were included in the analysis. The study found that women with a high EndoPredict score (i.e., >3.3) and who received ET+C had significantly lower 10-year recurrence risk than those on ET alone (Graph 1). However, there were no significant differences between ET+C and ET for patients with low EndoPredict scores, suggesting these women are unlikely to benefit from adjuvant chemotherapy.
“In this analysis with modern chemotherapy regimens, patients with a high EndoPredict test score who received endocrine therapy and chemotherapy had significantly better outcomes than those receiving endocrine therapy alone,” said Ivana Sestak, Ph.D., principle investigator, Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London. “Based on these findings, oncologists should use the EndoPredict test to make decisions about the best course of treatment for their patients.”
Graph 1: EndoPredict® Predicts Chemotherapy Benefit in Women with ER+, HER-Breast Cancer is available at the following address:
“EndoPredict is an advanced precision medicine test, and is the only test with the scientific rigor to provide superior risk-stratification for patients with both node+/- breast cancer, to identify those patients who can safely forgo extended endocrine therapy after five years and importantly, predict chemotherapy benefit,” said Johnathan Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetics. “EndoPredict is covered by nearly all health insurers in the United States because they have recognized the ability of EndoPredict to address unmet medical needs, improve health outcomes for women and potentially save the healthcare systems tens of millions of dollars.”
The EndoPredict test was recently included in The National Comprehensive Cancer Network (NCCN) Guidelines for breast cancer. Follow Myriad on Twitter via @MyriadGenetics to stay informed about news and updates from the Company.
About Breast Cancer
One in eight American women will have breast cancer during her lifetime. Breast cancer is the second leading cause of cancer death among American women. The American Cancer Society estimates in its Cancer Facts & Figures 2019 report that more than 268,000 women will be told they have breast cancer in 2019.
EndoPredict is a second-generation, prognostic test that aids personalized treatment planning for patients with early-stage breast cancer. EndoPredict has been validated in over 3500 patients with node-negative and node-positive disease and is the leading breast prognostic in Europe. In contrast to first-generation multigene prognostic tests, EndoPredict incorporates a 12-gene molecular score with known prognostic factors tumor size and nodal status. In clinical studies, EndoPredict demonstrated its robust ability to predict recurrence risk across multiple time-periods: 0-5, 5-10, and 5-15 years. EndoPredict provides clinically actionable information to physicians and patients as they consider the use of adjuvant chemotherapy and extended endocrine therapy.
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 critical success factors: build upon a solid hereditary cancer foundation, grow new product volume, expand reimbursement coverage for new products, increase RNA kit revenue internationally and improve profitability with Elevate 2020.
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.
Oncotype Dx is a registered trademark of Genomic Health, Inc.
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to clinicians being able to use the EndoPredict test to personalize their care by directing chemotherapy to women with a high likelihood of benefit, while preventing the over-treatment of women who are unlikely to benefit; oncologists using the EndoPredict test to make decisions about the best course of treatment for their patients; EndoPredict providing superior risk-stratification for patients with both node+/- breast cancer, identifying those patients can safely forgo extended endocrine therapy after five years and predicting chemotherapy benefit; the ability of EndoPredict to address unmet medical needs, improve health outcomes for women and potentially save the healthcare systems tens of millions of dollars; 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.