Researchers will use Trovagene's proprietary transrenal DNA(TrDNA) detection technology to evaluate BRAF mutation status in urine ascompared to tissue biopsy. The study also calls for monitoring of mutationlevels in the urine at planned intervals during and after treatment to assessoutcomes including: response rate; stable disease; progression-free survival;and overall survival. Results from patients who receive therapy that reflectstheir BRAF mutation status (e.g.,BRAF inhibitors, MEK inhibitors) will be compared to outcomes for patients whoreceive standard-of-care therapy regardless of mutation status.
According to recent estimates, BRAF mutations are present inmore than 20 percent of all cancers, and in 40 percent and 43 percent of allthyroid and skin cancer samples, respectively. Several targeted therapies forBRAF-mutated melanomas are already on the market and in development, includingBRAF inhibitors vemurafenib (Zelboraf) and dabrafenib; and trametinib, a MEKinhibitor.
"One of the potential benefits of TrDNA would be its utilityas a systemic, liquid biopsy, providing real-time information that may helpguide targeted therapy decisions, and then help clinicians more easily monitora patient's therapeutic response and disease state," said Dr. Filip Janku, principalinvestigator for the study at MD Anderson. "A urine-based assay that reliablyand cost-effectively detects mutations would be extremely useful as an aid inpersonalized medicine."
"This study represents a first-of-its kind look at howurine-based mutation detection can be used to track patients from initialdiagnosis through therapy, and then to monitor for early signs of progression,"said Dr. Charlie Rodi, chief technology officer at Trovagene. "We are pleasedto sponsor this study with MD Anderson, and look forward to learning more aboutthe unique properties and clinical utilities of our transrenal mutationassays."
