Large Prospective Trial Validates Detection of AR-V7 Biomarker Using Epic Sciences' Platform to Predict Treatment Outcomes for Patients with Advanced Prostate Cancer
SAN DIEGO, March 13, 2019 /PRNewswire/ -- Epic Sciences, Inc. (Epic) today announced the publication of results from a multicenter prospective trial validating the biomarker AR-V7 (androgen receptor splice variant-7) as a predictor of resistance to anti-androgen therapy in men with metastatic castration-resistant prostate cancer (mCRPC). Data from the PROPHECY trial, published in the Journal of Clinical Oncology, demonstrate that detection of AR-V7 in circulating tumor cells (CTCs) in blood is predictive of whether men with mCRPC have become resistant to androgen-receptor signaling (ARS) inhibitors and have a low chance of benefit from further ARS therapy.
Many men with mCRPC live longer when treated with the potent androgen receptor (AR) pathway inhibitors enzalutamide and abiraterone, which are considered the standard of care. However, in patients previously treated with one round of AR therapy, response rates are low and progression-free survival (PFS) and overall survival (OS) times are short. Moreover, cross resistance between these agents is common, and clinical features alone are unable to identify tumors that are cross-resistant. Therefore, predictive biomarkers are urgently needed to permit physicians and patients to select the most optimal therapies.
In the paper entitled "Prospective multicenter validation of AR-V7 and hormone therapy resistance in prostate cancer: the PROPHECY study," researchers led by Andrew J. Armstrong, M.D., ScM, FACP, Professor of Medicine, Surgery, Pharmacology and Cancer Biology; Director of Research, the Duke Cancer Institute Center for Prostate and Urologic Cancers, Divisions of Medical Oncology and Urology at Duke University, conducted this prospective, blinded clinical trial to validate the predictive significance of baseline CTC AR-V7 based on PFS as the primary endpoint, as well as OS, in 118 men with mCRPC undergoing ARS inhibitor therapy.