EndoPredict (EPclin) Shown in Second Study to be More Effective than Oncotype DX® (RS) in Women with Intermediate Risk of Breast Cancer Recurrence
SALT LAKE CITY, Oct. 26, 2017 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced new positive results for EndoPredict®, a second-generation prognostic gene expression test for breast cancer. The study found that EndoPredict (EPclin) was superior to the first-generation Oncotype DX Breast Recurrence Score® (RS) in predicting breast cancer recurrence in women determined to be at intermediate clinical risk by Nottingham Prognostic Index. The data will be presented at the 3rd World Congress on Controversies in Breast Cancer (CoBrCa) being held Oct. 26-28, 2017 in Tokyo, Japan.
This is the second head-to-head study to show that EndoPredict significantly outperformed the first-generation prognostic test for breast cancer, especially for predicting the distant recurrence of breast cancer, and underscores Myriad's unwavering commitment to advancing precision medicine for women with breast cancer. The first study was published in the Journal of the National Cancer Institute (JNCI) in July 2016.
"This new study is further evidence that compared to the first generation test, EndoPredict more effectively predicts the recurrence of breast cancer up to 10 years after diagnosis in women with ER+, HER2- breast cancer," said Ivana Sestak, Ph.D., principal investigator, Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London. "These findings will help physicians personalize treatment for women with an intermediate clinical risk of recurrence by identifying those patients who need adjuvant chemotherapy following surgery."
Title: Comparison of prognostic performance of Oncotype Dx Recurrence Score versus EndoPredict (EPclin) in women with intermediate risk of recurrence by Nottingham Prognostic Index.
Presenter: Ivana Sestak, Ph.D.
Date: Friday, Oct. 27 3:30 to 4:30 p.m.
Programme Number: OR01.
The analysis included 387 women with ER-positive, HER2-negative breast cancer and who were determined to be at intermediate risk of recurrence as defined by the Nottingham Prognostic Index (NPI). The primary endpoint was distant recurrence and the primary objective was to assess the value of EndoPredict (EPclin) for the prediction of (late) distant recurrence and compare the results to Oncotype Recurrence Score (RS).
This study showed that EndoPredict markedly outperformed Oncotype across the 10-year follow-up period with prognostic power more than two times higher (EPclin: LRX2= 14.1; RS: LRX2=5.9).
In this analysis, EndoPredict stratified 149 (38.5 percent) women into the low risk group and 238 (61.5 percent) into the high risk group. A highly significant separation between the groups was observed. The 10-year distant recurrence (DR) was 12.5 percent for the low risk group vs. 25.9 percent for the high risk group (HR=2.42). However, for Oncotype, the DR rate was 16.3 percent for the low risk group and no clear separation between intermediate and high risk groups was observed, with similar 10-year distant recurrence risks (24.2 vs. 27.3 percent, respectively).
Additionally, for the prediction of late distant recurrence (5-10 years), EndoPredict provided significant prognostic value in this time period and identified 136 (40.2 percent) patients as low risk and 202 (59.8 percent) as high risk, while the first generation test did not provide prognostic value for late metastasis for women deemed intermediate risk of recurrence by NPI. These results confirm the importance of the inclusion of clinicopathological data to achieve best prognostication in this patient group.
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EndoPredict is a second-generation, multigene prognostic test for patients diagnosed with breast cancer. The test provides physicians with information to devise personalized treatment plans for their patients. EndoPredict has been validated in approximately 4,000 patients with node-negative and node-positive cancer and has been used clinically in over 13,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: www.endopredict.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 three strategic imperatives: maintaining leadership in an expanding hereditary cancer market, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. 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, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra DA, GeneSight, EndoPredict and Prolaris 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 and Oncotype DX Breast Recurrence Score are registered trademarks 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 relating to related to the study data to be presented at the 3rd World Congress on Controversies in Breast Cancer (CoBrCa) being held Oct. 26-28, 2017 in Tokyo, Japan; the study findings that EndoPredict (EPclin) was superior to the first-generation tests in predicting breast cancer recurrence in women determined to be at intermediate clinical risk by Nottingham Prognostic Index; EndoPredict testing more effectively predicting the recurrence of breast cancer up to 10 years after diagnosis in women with ER+, HER2- breast cancer; the study results helping physicians personalize treatment for women with an intermediate clinical risk of recurrence by identifying those patients who need adjuvant chemotherapy following surgery; and the Company's strategic directives under the captions "About EndoPredict" and "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 described or implied in the forward-looking statements. These risks include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and pharmaceutical and clinical services may decline or will not continue to increase at historical rates; risks related to our ability to transition from our existing product portfolio to our new tests; risks related to changes in the 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 tests and any future tests are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities; 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, including but not limited to our acquisition of Assurex, Sividon and the Clinic; risks related to our projections about the potential market opportunity for our products; 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; 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, 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.
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