myChoice HRD(TM) Test Identifies Breast Cancer Patients Likely to Respond to Platinum-Containing Therapies
SALT LAKE CITY, Dec. 10, 2015 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced that new data will be presented demonstrating the role of the myChoice HRD companion diagnostic in identifying patients with breast cancer who are likely to respond to a platinum-containing therapy. The data will be presented at the 2015 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.
"There is mounting clinical evidence demonstrating the ability of myChoice HRD to identify patients who experience improved outcomes when treated with platinum-containing therapy," said Anne-Renee Hartman, M.D., vice president of clinical development, Myriad Genetic Laboratories. "Our collaborators will present data showing how this test might be useful to optimize therapy selection for patients. The data underscore the critical importance of identifying patients at the time of diagnosis who are likely to benefit from a therapeutic response to platinum prior to surgery. These findings support earlier studies showing that myChoice HRD gives the most complete picture of clinical response to platinum-containing chemotherapy."
Details about the featured myChoice HRD presentations at SABCS are below. Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS15.
myChoice HRD Presentations
Title: Homologous recombination deficiency (HRD) as a predictive biomarker of response to neoadjuvant platinum-based therapy in patients with triple negative breast cancer (TNBC); A pooled analysis.
Date: Thursday, Dec.10, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P3-07-12.
Presenter: Dr. Melinda Telli, Stanford University Cancer Center.
A pooled analysis of five Phase II trials that included patients with TNBC treated with neoadjuvant platinum-based chemotherapy was conducted to evaluate the pathologic complete response (pCR) rates in homologous recombination (HR) deficient and HR non-deficient tumors. HR deficiency status was defined as either a positive myChoice HRD score (42 or higher) or presence of a BRCA1/2 tumor mutation (tBRCA). The results of this analysis with 267 patients showed that myChoice HRD predicted pCR in TNBC across several different platinum-based chemotherapy regimens. Specifically, patients with a positive myChoice HRD score had a five-fold increase in pCR compared to those with negative score.
Title: Homologous recombination deficiency (HRD) as a predictive biomarker of response to preoperative systemic therapy (PST) in TBCRC008 comprising a platinum in
HER2-negative primary operable breast cancer.
Date: Thursday, Dec.10, 2015: 5:00 to 7:00 p.m. CT.
Location: Poster P3-07-13.
Presenter: Dr. Roisin Connolly, Johns Hopkins School of Medicine.
This study assessed the ability of myChoice HRD to predict pathological complete response (pCR) in 48 patients with ER-positive or triple negative breast cancer who were treated with PST comprising a platinum drug. In the analysis of all patients, the results showed a significantly higher pCR rate in patients with a positive myChoice HRD score than a negative score (50 percent vs 8 percent, p=0.002). A similar trend was observed for both ER-positive and TNBC patients. In a subgroup analysis of patients without a tBRCA mutation (n=40), there was a significantly higher pCR rate in patients with a positive myChoice HRD score than a negative score (64 percent vs 8 percent, p≤0.001). These results show that myChoice HRD predicts response to a platinum-containing chemotherapy regimen in the estimated 15 percent of newly diagnosed breast cancer patients with TNBC. Furthermore, this is the first study to show that myChoice HRD may be useful in predicting response to platinum-containing chemotherapy regimens in patients with ER-positive, Her2-negative breast cancer, which represents approximately 70 percent of newly diagnosed breast cancer patients.
For more information about these presentations, please visit the SABCS website at https://www.sabcs.org/.
About myChoice HRD™
Myriad's myChoice HRD is the first homologous recombination deficiency test that can detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. High myChoice HRD scores reflective of DNA repair deficiencies are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.8 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents.
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: transitioning and expanding its hereditary cancer testing markets, 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, myPath, myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra 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
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 likelihood of patients with a positive myChoice HRD™ score to be five times more likely to respond to platinum-containing therapies; the usefulness of the myChoice HRD test to optimize therapy selection for patients; the myChoice HRD test giving the most complete picture of clinical response to platinum-containing chemotherapy; 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; 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, 2015, 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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