Study of Endopredict test shows influence on outcome in breast cancer.- Myriad Genetics.

Myriad Genetics announced the first prospective outcomes data on EndoPredict Test at the San Antonio Breast Cancer Symposium. This prospective study evaluated outcomes data of patients whose adjuvant systemic chemotherapy recommendation was based on the EndoPredict (EPclin) test result. One of the key findings is that EndoPredict high-risk patients had a better outcome with adjuvant chemotherapy compared to endocrine therapy alone.

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.

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. 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).