On October 26, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported new positive results for EndoPredict, a second-generation prognostic gene expression test for breast cancer (Press release, Myriad Genetics, OCT 26, 2017, View Source [SID1234521201]). 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.

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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.”

Oral Presentation.
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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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 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.