Maha Hussain, MD, Professor of Medicine and Urology, University of Michigan, associate director, Clinical Research, co-leader, Prostate Cancer/GU Oncology Program, assistant chief, Clinical Research at the Division of Hematology/ Oncology, University of Michigan Comprehensive Cancer Center, discusses the possibility of utilizing ETS gene fusions as predictive biomarkers in prostate cancer.
Research has suggested that the presence of ETS gene fusions could be a potential predictive biomarker, fulfilling an unmet need. These fusions occur in early stage disease, Hussain says, and research suggests their presences are a driver of cancer development.
NCI 9012, a randomized ETS fusion-stratified phase II trial, is the first biomarker-based trial in prostate cancer. Hussain says that real tissue biopsies from metastatic patients were evaluated for the ETS status. The patients were broken up into two groups (ETS positive and ETS negative) and were then randomized to abiraterone versus abiraterone plus veliparib.
So far, 125 patients have been enrolled in the study and over 100 patients in the trial have been randomized. Hussain says results so far have shown 75% biopsy yield in the bone and nearly 100% biopsy yield in the soft-tissue disease.
This is a pioneer trial that should hopefully open the door to more development of biopsy-based trials and combination therapy development, Hussain believes.
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