Myriad Genetics Presents Results From Two Important EndoPredict® Studies at the 2017 San Antonio Breast Cancer Symposium

SALT LAKE CITY, Dec. 08, 2017 (GLOBE NEWSWIRE) — Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, today announced new results from two studies with EndoPredict® are being featured at the 2017 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas.  EndoPredict is a second-generation prognostic gene expression test for patients with breast cancer.
“We are excited to present new data on our EndoPredict test which demonstrates our ongoing commitment to collaborate with leading academic research centers and advance personalized medicine for patients with breast cancer,” said Ralf Kronenwett, M.D., Ph.D., director of International Medical Affairs, Myriad Genetics.  “Importantly, these new studies add to the expanding body of evidence demonstrating how EndoPredict can be used to predict both disease recurrence as well as response to therapy.”
The data are highlighted below and abstracts are available at: https://www.sabcs.org/2017-SABCS.  Follow Myriad on Twitter via @MyriadGenetics and stay informed about symposium news and updates by using the hashtag #SABCS17.

EndoPredict Podium Presentation
Title:  The EndoPredict score predicts residual cancer burden to neoadjuvant chemotherapy and to neuroendocrine therapy in HR+/HER2- breast cancer patients from ABCSG34.
Presenter:  Peter Dubsky, M.D., Medical University of Vienna, Austria and the Breast Center St. Anna Klinik, Lucerne.
Date:  Friday, Dec. 8, 2017, 3:15–5:00 p.m.
Location:  Podium, GS6-04

This study was designed to show the predictive value of the EndoPredict (EP) 12-gene molecular score for tumor response to neoadjuvant chemotherapy and neoendocrine therapy.  The study included biopsies from 217 women with HR+ breast cancer.  Of these, 134 patients were assigned to receive neoadjuvant chemotherapy according to aggressive clinico-pathologic tumor features.  The remaining 83 patients were clinically identified as having luminal A types of breast cancer and were assigned to receive neoendocrine treatment.  The primary endpoint was residual cancer burden RCB0/I (i.e., good tumor response) vs. RCB II/III (i.e., poor tumor response) at time of surgery.
In the neoadjuvant chemotherapy group, 125 patients had high EP scores and nine had a low EP score.  The results show that 26.4 percent of those with a high score showed a good tumor response (RCB0/I) to neoadjuvant chemotherapy, while all patients with a low score showed only a poor tumor response (Table 1).  In the “luminal A” group receiving neoendocrine therapy, 39 patients had a high EP score and 44 had a low EP score.  The results show that 27.3 percent of those with a low EndoPredict score and 7.7 percent with a high score achieved excellent tumor response (RCB0/I) to neoendocrine therapy (Table 1).

       
Table. 1 EndoPredict
Low Score
EndoPredict
High Score
p-Value
Response to
Neoadjuvant
Chemotherapy
0.0 % 26.4 % p=0.0001
Response to
Endocrine Therapy
27.3 % 7.7 % P=0.015
           

“This exciting study is evidence that women with a high EP score responded better to neoadjuvant chemotherapy than those with a low score, while those with a low EndoPredict score responded better to neoadjuvant endocrine therapy,” said Peter Dubsky, M.D., principal investigator, speaking on behalf of the Austrian Breast and Colorectal Cancer Study Group (ABCSG).  “These findings are relevant to better patient selection for biomarker driven studies in the neoadjuvant setting.”

EndoPredict Poster Presentation
Title:  The role of EndoPredict in invasive lobular carcinoma.
Presenter:  Ivana Sestak, Ph.D., Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London. 
Date:  Thursday, Dec. 7, 2017, 5:00–7:00 p.m.
Location:  Poster, P3-08-01

This study evaluated the role of EndoPredict molecular-clinical score (EPclin) for the prediction of distant recurrence in women diagnosed with invasive lobular carcinoma (ILC) compared to those with invasive ductal carcinoma (IDC).  The study included 928 women with E R+/HER2- breast cancer: 141 had ILC, 710 had IDC and 77 were mixed type.
This result shows that EndoPredict provided significant power for predicting distant recurrence in patients with both ILC (EPclin: LR-X2=5.8) and IDC (EPclin: LR-X2=13.8).  Women with ILC who had a high EPclin score were at seven times increased risk of 10-year distant recurrence with endocrine therapy only than patients with low EPclin score.  In comparison, women with IDC who had a high EPclin score were at five times increased risk of 10-year recurrence than patients with low EPclin score.  Importantly, there was a similar 10-year distant recurrence risk in patients with a low EPclin score (~6 percent), which suggests that chemotherapy is not indicated in these patients with a low risk score regardless of tumor type.
“Our results show that EndoPredict provided highly significant prognostic information and risk stratification in women with invasive lobular carcinoma,” said Ivana Sestak, Ph.D., principal investigator, Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London.  “Importantly, the 10-year risk of distant recurrence in the EndoPredict low-risk groups was similar between ILC and IDC, suggesting that chemotherapy is not indicated for these patients, irrespective of tumor type.”

About EndoPredict
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 more than 20,000 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 five strategic imperatives:  stabilizing hereditary cancer revenue, growing new product volume, expanding reimbursement coverage for new products, increasing RNA kit revenue internationally and improving profitability with Elevate 2020.  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, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore 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 relating to the presentation of two new positive studies for the EndoPredict Test at the 2017 San Antonio Breast Cancer Symposium; the study results demonstrating that the EndoPredict test accurately predicts response to neoadjuvant chemotherapy and neoendocrine therapy in women with HR+ breast cancer; the ability of EndoPredict to be used to predict both disease recurrence as well as response to therapy; the study evidencing that women with a high EP score responded better to neoadjuvant chemotherapy than those with a low score, while those with a low EndoPredict score responded better to neoadjuvant endocrine therapy; the relevance of these findings to better patient selection for biomarker driven studies in the neoadjuvant setting; 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 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.

Media Contact:
Ron Rogers
(908) 285-0248     
rrogers@myriad.com

Investor Contact:     
Scott Gleason
(801) 584-1143
sgleason@myriad.com