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Myriad Announces Important New Data for Its EndoPredict® Breast Cancer Test Will Be Presented at the 2018 San Antonio Breast Cancer Symposium
EndoPredict is the Only Test to Answer Three Critical Questions: Risk of Breast Cancer Recurrence, Benefits of Chemotherapy and Who Can Forgo Extended Endocrine Therapy
SALT LAKE CITY, Dec. 07, 2018 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a global leader in personalized medicine, today announced that new data on its EndoPredict® test will be presented by academic collaborators at the San Antonio Breast Cancer Symposium. The key findings are that EndoPredict accurately predicts which women with ER-positive, HER2-negative breast cancer will benefit from adjunctive chemotherapy at the time of diagnosis and who is unlikely to benefit from extended endocrine therapy five years after diagnosis. The EndoPredict test was recently included in The National Comprehensive Cancer Network (NCCN) Guidelines for breast cancer.
“Women with breast cancer, and the clinicians caring for them, will benefit from a single comprehensive solution to answer critical clinical questions about long-term prognosis, the need for adjuvant chemotherapy and the need for extended endocrine therapy,” said Johnathan Lancaster, M.D., Ph.D., gynecologic oncologist and chief medical officer, Myriad Genetics. “The new data we are presenting at SABCS demonstrate that EndoPredict is the only test that answers all three questions, enabling precision care and better health outcomes for women battling breast cancer.”
“These important studies highlight scientific advances that are foundational to a new generation of breast cancer precision medicine tools; one genetic test, providing multiple clinical answers,” said Hatem Soliman, M.D., medical oncologist, Center for Women’s Oncology, Moffitt Cancer Center. “We should collectively utilize these new technologies to help inform our treatment decisions and improve the quality of life for our patients.”
The key data being presented at SABCS are summarized below. Please visit Myriad at Booth #1001 to learn more about genetic testing for breast cancer. Follow Myriad on Twitter via @myriadgenetics and keep up to date with Symposium news and updates by using the hashtag #SABCS18.
Prediction of Chemotherapy Benefit
Title: Prediction of distant recurrence by EndoPredict in patients with ER-positive, HER2-negative breast cancer who received adjuvant endocrine therapy plus chemotherapy or endocrine therapy alone.
Presenter: Ivana Sestak, Ph.D., Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London.
Date: Thursday, Dec. 6, 2018, 7:30-9:00 a.m.
This retrospective analysis of five prospective studies evaluated whether EndoPredict (EPclin) can predict the chemotherapy benefit in 3,746 women with ER-positive, HER2-negative breast cancer who have received five years of endocrine therapy (ET) alone or in combination with chemotherapy (ET+C). The primary endpoint was the 10-year distant recurrence free interval (DRFI).
The results demonstrated that patients with a high (>3.3) EndoPredict score on ET+C had a significantly lower 10-year DR risk than those on ET alone (Graph 1). In contrast, there were no significant differences in the 10-year DR between ET and ET+C for patients with low (<3.3) EndoPredict Scores (Graph 1). These findings were statistically significant (p=0.02) and confirm that EndoPredict was able to accurately predict chemotherapy benefit in women with ER-positive, HER2-negative breast cancer.
Graph 1: EndoPredict® Accurately Predicts Chemotherapy Benefit In Women with ER+, HER-Breast Cancer.
A graph accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/60da15c0-b95e-4351-bc31-d0a176e90e0c
“In this study with contemporary chemotherapy regimens, patients with a high EndoPredict test score who received endocrine therapy plus chemotherapy had significantly better outcomes than those receiving endocrine therapy alone,” said Ivana Sestak, Ph.D., principal investigator, Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London. “Based on these findings, EndoPredict may be used in the decision-making process about adjunctive chemotherapy.”
Prediction of Distant Recurrence Informs Extended Endocrine Decision
Title: Prediction of distant recurrence using EndoPredict among women with ER-positive, HER2-negative breast cancer with a maximum follow-up of 16 years.
Presenter: Martin Filipits, Ph.D., Institute of Cancer Research, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna Head of ABCSG Research.
Date: Friday, Dec. 7, 2018, 7:30-9:00 a.m.
This study assessed the ability of the EndoPredict (EPclin) test to predict early distant recurrence (0-10 years) and late recurrence (5-15 years) of breast cancer, according to nodal status. The analysis included 1,702 patients with ER-positive, HER2-negative breast cancer who received five years of endocrine therapy alone. Overall, 62.2 percent of patients had low EndoPredict scores.
The results demonstrated that EndoPredict is highly predictive of both early and late distant recurrence (DR), regardless of nodal status. Women with low EndoPredict scores had statistically significantly reduced risk compared to those with high scores (Table 1).
Table 1: Women with Low EndoPredict Scores Had Significantly Better Outcomes
|Freedom from Distant Recurrence|
(Early 0-10 Years)
|Freedom from Distant Recurrence|
(Late 5-15 Years)
|P-value||P<0.0001; HR: 4.77||P<0.0001; HR: 4.52|
“In this study, women with a high EndoPredict score were four times more likely to experience a breast cancer recurrence setback,” said Martin Filipits, Ph.D., principal investigator, Institute of Cancer Research, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna Head of ABCSG Research. “Importantly, the low risk group had a 4 percent rate of distant recurrence in years 5-15 compared to 16 percent in the high risk group, which suggests that EndoPredict can help select patients who can safely forgo extended endocrine therapy beyond five years.”
Prediction of the 10-Year Risk of Breast Cancer Recurrence
The findings above build on research previously published in the Journal of the National Cancer Institute. That study included 928 women from the TransATAC study and compared the prognostic power of EndoPredict (EPclin) versus Oncotype Dx® (RS) with distant relapse-free survival as the primary endpoint. This analysis showed that EndoPredict markedly outperformed Oncotype DX across the 10-year follow-up period with prognostic power more than four times higher (EPclin: LRX2= 139.3; RS: LRX2=29.1). Importantly, the study authors noted: “EPclin’s superior ability to classify patients as low risk was further demonstrated by the similar number of patients classified as low risk by RS coupled with a substantially lower 10-year recurrence rate (5.8 percent for EPclin vs 10.1 percent for RS).”
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 2018 report that more than 250,000 women will be told they have breast cancer in 2018.
EndoPredict is a second-generation, multigene prognostic test that aids personalized treatment planning for patients with early-stage breast cancer. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive disease and has been used clinically in more than 25,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict is validated to accurately predict both early (0-5) and late (5-15 years) distant recurrence and for prediction of benefit from both adjuvant chemotherapy as well as which patients can safely forgo extended endocrine therapy beyond five years.
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 Prelude 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 the Company’s data across multiple genetic tests being featured at the San Antonio Breast Cancer Symposium being held Dec. 4-8, 2018 in San Antonio, Texas; the benefit from a single comprehensive solution to answer critical clinical questions about long-term prognosis, the need for adjuvant chemotherapy and the need for extended endocrine therapy; 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.