Presenting at the San Antonio Breast Cancer symposium, Myriad Genetics (MYGN) said new data shows that its EndoPredict can accurately predict 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. Additionally, the company said results also help identify risk of breast cancer recurrence. In an exclusive interview with The Fly, Myriad’s Chief Medical Officer Johnathan Lancaster discussed the results and how genome technology is transforming medicine and cancer care.
ENDOPREDICT STUDY RESULTS: Myriad Genetics presented new data for its EndoPredict breast cancer test at the 2018 San Antonio Breast Cancer symposium. The company said the key findings include 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. Regarding the prediction of distant recurrence by EndoPredict in patients with ER-positive, HER2- negative breast cancer who received adjuvant endocrine therapy plus chemotherapy or endocrine therapy alone, Myriad said the results demonstrated that patients with a high EndoPredict score on ET+C had a significantly lower 10-year DR risk than those on ET alone. In contrast, there were no significant differences in the 10-year DR between ET and ET+C for patients with low EndoPredict Scores. These findings were statistically significant and confirm that EndoPredict was able to accurately predict chemotherapy benefit in women with ER-positive, HER2-negative breast cancer. Regarding prediction of distant recurrence using EndoPredict among women with ER-positive, HER2-negative breast cancer with a maximum follow-up of 16 years, the results demonstrated that EndoPredict is highly predictive of both early and late distant recurrence, regardless of nodal status. Women with low EndoPredict scores had statistically significantly reduced risk compared to those with high scores. Discussing the first prospective outcome data for the clinic-molecular test EndoPredict in hormone receptor positive, HER2-negative early breast cancer in clinical routine, Myriad said results show that the disease free survival and distant metastases free survival in the low-risk group was 96.6% and 99.6% compared to 94.9% and 97.6% in the high-risk group. These results equate to a two-fold higher risk of disease recurrence and a five-fold higher risk of distant metastases in patients with high EndoPredict scores versus low scores. The analysis also demonstrated that EndoPredict high-risk patients who received adjuvant chemotherapy had a 3-year DFS of 96.3% compared to 91.5% in those high-risk patients who did not receive chemotherapy.
GENOME TECHNOLOGY ‘TRANSFORMING CANCER CARE’: “With one test we provide answers to three critical questions: what is the patient’s prognosis, what is likelihood of reoccurrence over 10 and 15 years? Which patient needs chemotherapy, which patient is going to benefit from chemotherapy and which patient can forgo chemotherapy? And which patients are at highest risk of late recurrence and which patients that get to five years with endocrine therapy and haven’t experience a recurrence can safely avoid an additional five years of endocrine therapy? So, with one test we provide three comprehensive answers to enhance the ability of clinicians to individualize care for patients with breast cancer,” Myriad’s chief medical officer Johnathan Lancaster told The Fly. “The power of genomics technology is transforming medicine, its transforming cancer care and more importantly, it’s transforming a clinicians’ ability to manage patients. We know that the “one size fits all” approach is suboptimal. A patient sitting in a clinical office who want to know if they need chemotherapy don’t care about 2000/3000 patients; they care about themselves,” he explained.
GOAL IS TO ‘TAKE AS MUCH MARKET SHARE AS POSSIBLE’: “At the time of launch of EndoPredict we had 90%-plus coverage in terms of reimbursement from payers and that’s because health insurance payers recognize the value of this product, that it has been a market leader in Europe for a good number of years, was priced appropriately and fairly, and they recognize that it was going save lives and make more judicious use of health care costs by identifying patients who don’t need chemotherapy. The payer market was very welcoming of this product. Our objective is to take as much market share as possible for one simple reason: it’s the better test out there and we want as many as patients as possible to benefit from this generation of tests. […] The questions I’m receiving at this conference about these latest data reflect that and I think the clinical community recognizes that they are ready for a next generation of tests,” Lancaster added.
