EndoPredict is the Only Test to Answer Three Critical Questions

EndoPredict is the Only Test to Answer Three Critical Questions: Risk of Breast Cancer Recurrence, Benefits of Chemotherapy and Who Can Forgo Extended Endocrine Therapy

Myriad Genetics announced that new data on its EndoPredict® test will be presented by academic collaborators at the San Antonio Breast Cancer Symposium.  The key findings are that EndoPredict accurately predicts which women with ER-positive, HER2-negative breast cancer will benefit from adjunctive chemotherapy at the time of diagnosis and who is unlikely to benefit from extended endocrine therapy five years after diagnosis.  The EndoPredict test was recently included in The National Comprehensive Cancer Network (NCCN) Guidelines for breast cancer.  (Click here for the full news release on 12/7/2018)

“Women with breast cancer, and the clinicians caring for them, will benefit from a single comprehensive solution to answer critical clinical questions about long-term prognosis, the need for adjuvant chemotherapy and the need for extended endocrine therapy,” said Johnathan Lancaster, M.D., Ph.D., gynecologic oncologist and chief medical officer, Myriad Genetics.  “The new data we are presenting at SABCS demonstrate that EndoPredict is the only test that answers all three questions, enabling precision care and better health outcomes for women battling breast cancer.”

“These important studies highlight scientific advances that are foundational to a new generation of breast cancer precision medicine tools; one genetic test, providing multiple clinical answers,” said Hatem Soliman, M.D., medical oncologist, Center for Women’s Oncology, Moffitt Cancer Center.  “We should collectively utilize these new technologies to help inform our treatment decisions and improve the quality of life for our patients.”

The key data being presented at SABCS are summarized below.  Please visit Myriad at Booth #1001 to learn more about genetic testing for breast cancer.  Follow Myriad on Twitter via @myriadgenetics and keep up to date with Symposium news and updates by using the hashtag #SABCS18.

Prediction of Chemotherapy Benefit: *Presented at the 2018 San Antonio Breast Cancer Symposium

This retrospective analysis of five prospective studies evaluated whether EndoPredict (EPclin) can predict the chemotherapy benefit in 3,746 women with ER-positive, HER2-negative breast cancer who have received five years of endocrine therapy (ET) alone or in combination with chemotherapy (ET+C).  The primary endpoint was the 10-year distant recurrence free interval (DRFI).

The results demonstrated that patients with a high (>3.3) EndoPredict score on ET+C had a significantly lower 10-year DR risk than those on ET alone (Graph 1).  In contrast, there were no significant differences in the 10-year DR between ET and ET+C for patients with low (<3.3) EndoPredict Scores (Graph 1).  These findings were statistically significant (p=0.02) and confirm that EndoPredict was able to accurately predict chemotherapy benefit in women with ER-positive, HER2-negative breast cancer.

Graph 1: EndoPredict® Accurately Predicts Chemotherapy Benefit In Women with ER+, HER-Breast Cancer.

 “In this study with contemporary chemotherapy regimens, patients with a high EndoPredict test score who received endocrine therapy plus chemotherapy had significantly better outcomes than those receiving endocrine therapy alone,” said Ivana Sestak, Ph.D., principal investigator, Centre for Cancer Prevention, Wolfson Institute of Preventive Medicine, Queen Mary University of London.  “Based on these findings, EndoPredict may be used in the decision-making process about adjunctive chemotherapy.”





Prediction of Distant Recurrence Informs Extended Endocrine Decision: *Presented at the 2018 San Antonio Breast Cancer Symposium

This study assessed the ability of the EndoPredict (EPclin) test to predict early distant recurrence (0-10 years) and late recurrence (5-15 years) of breast cancer, according to nodal status.  The analysis included 1,702 patients with ER-positive, HER2-negative breast cancer who received five years of endocrine therapy alone.  Overall, 62.2 percent of patients had low EndoPredict scores.

The results demonstrated that EndoPredict is highly predictive of both early and late distant recurrence (DR), regardless of nodal status.  Women with low EndoPredict scores had statistically significantly reduced risk compared to those with high scores (Table 1).

Table 1:  Women with Low EndoPredict Scores Had Significantly Better Outcomes

   EPclin Score Freedom from Distant Recurrence (Early 0-10 Years) Freedom from Distant Recurrence (Late 5-15 Years)
 Low Risk 95.5% 95.7%
 High Risk 80.3% 84.1%
 P-value P<0.0001; HR: 4.77 P<0.0001; HR: 4.52


“In this study, women with a high EndoPredict score were four times more likely to experience a breast cancer recurrence setback,” said Martin Filipits, Ph.D., principal investigator, Institute of Cancer Research, Breast Health Center and Comprehensive Cancer Center, Medical University of Vienna Head of ABCSG Research.  “Importantly, the low risk group had a 4 percent rate of distant recurrence in years 5-15 compared to 16 percent in the high risk group, which suggests that EndoPredict can help select patients who can safely forgo extended endocrine therapy beyond five years.”

Prediction of the 10-Year Risk of Breast Cancer Recurrence

The findings above build on research previously published in the Journal of the National Cancer Institute.  That study included 928 women from the TransATAC study and compared the prognostic power of EndoPredict (EPclin) versus Oncotype Dx® (RS) with distant relapse-free survival as the primary endpoint.  This analysis showed that EndoPredict markedly outperformed Oncotype DX across the 10-year follow-up period with prognostic power more than four times higher (EPclin: LRX2= 139.3; RS: LRX2=29.1).  Importantly, the study authors noted: “EPclin’s superior ability to classify patients as low risk was further demonstrated by the similar number of patients classified as low risk by RS coupled with a substantially lower 10-year recurrence rate (5.8 percent for EPclin vs 10.1 percent for RS).”

For more information on EndoPredict by Myriad Genetics, click here: https://endopredict.com/