Prospective Study Demonstrates EndoPredict® Can Guide Chemotherapy Decision For Women with Early-Stage Breast Cancer
SALT LAKE CITY, (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a global leader in personalized medicine, today announced that academic researchers from the Technical University of Munich (TUM) presented the first prospective outcomes data on EndoPredict® at the San Antonio Breast Cancer Symposium in San Antonio, Texas. One of the key findings is that EndoPredict high-risk patients had a better outcome with adjuvant chemotherapy compared to endocrine therapy alone.
"There is a critical need for improved test options that optimally combine genetic information from the tumor with important clinical features and help clinicians develop precision treatment plans for women with breast cancer," said Johannes Ettl, M.D., lead investigator and head of the Gyneco-Oncological Outpatient Clinic, TUM "We are excited to present the first-ever prospective outcome data for the EndoPredict test which demonstrated the ability to predict disease free survival and guide decision of adjuvant chemotherapy use in hormone receptor positive, HER2-negative breast cancer."
The key data being presented at SABCS are summarized below.
Title: First prospective outcome data for the clinic-molecular test EndoPredict in hormone receptor positive, HER2-negative early breast cancer in clinical routine.
Presenter: Johannes Ettl, M.D., TUM.
Date: Friday, Dec. 7, 2018, 7:30-9:00 a.m.
This prospective study evaluated outcomes data of patients whose adjuvant systemic chemotherapy recommendation was based on the EndoPredict (EPclin) test result. All patients were evaluated for treatment compliance, local recurrence, distant metastases and survival. A total of 373 patients with HR+, HER2- early breast cancer pts with 0-3 positive lymph nodes were enrolled between March 2012 and March 2015. The EndoPredict test allocated 238 pts (63.8 percent) in the low-risk group and 135 pts (36.2 percent) in the high-risk group. Of these, 128 patients were recommended to undergo adjuvant chemotherapy in addition to endocrine therapy and 92 (72 percent) of patients were compliant having received standard-of-care chemotherapy.
EndoPredict High vs. Low Risk Scores
The results show that the disease free survival (DFS) and distant metastases free survival (DMFS) in the low-risk group was 96.6 percent and 99.6 percent compared to 94.9 percent and 97.6 percent in the high-risk group. These results equate to a two-fold (HR 2.05; p=0.110) higher risk of disease recurrence and a five-fold (HR 5.18; p=0.0443) higher risk of distant metastases in patients with high EndoPredict scores vs low scores.
Demonstration of Chemotherapy Benefit
The analysis also demonstrated that EndoPredict high-risk patients who received adjuvant chemotherapy had a 3-year DFS of 96.3 percent compared to 91.5 percent in those high-risk patients who did not receive chemotherapy (HR: 0.32; p=0.06).
"In this first analysis of clinical data from our breast center, patients who were classified as high risk by EndoPredict and who received chemotherapy experienced a 68 percent reduction in relapse compared to patients who did not receive the recommended chemotherapy," said Prof. Marion Kiechle, M.D., director of the Women´s Hospital, TUM. "After a median follow up of 3.5 years, the results approached statistical significance (p=0.06). For the first time, we looked at prospective data which demonstrated that EndoPredict has the capacity to predict chemotherapy benefit in EPclin high-risk patients. Future analyses with longer follow up will shed further light on this chemopredictive ability of the EndoPredict test."
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. EndoPredict is manufactured by Myriad Genetics, Inc.
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 presentation of prospective outcome data for the EndoPredict test, demonstrating the ability to predict disease free survival and guide decision of adjuvant chemotherapy use; 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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