Trovagene begins new study to assess precision cancer monitoring technology in lung cancer management

Trovagene, Inc., (NASDAQ: TROV) a developer of cell-free molecular diagnostics, announced today that it has expanded its clinical program to include a study designed to evaluate use of the Company's precision cancer monitoring technology in the management of lung cancer patients. The primary objective of the study is to detect and monitor EGFR mutations in urine, plasma and tissue to determine concordance. Secondary objectives include correlating quantitative EGFR mutational load over time with tumor burden, and demonstrating detection of the resistant EGFR T790M mutation prior to clinical or radiographic progression in lung cancer patients treated with tyrosine kinase inhibitor therapy. Approximately 225 patients are anticipated to be enrolled in the study.

"While it is standard of care to perform molecular testing on all patients with newly diagnosed metastatic lung adenocarcinoma, it is often difficult to obtain sufficient tissue from a non-surgical biopsy," stated Dr. Helena Yu, M.D., Assistant Attending Physician in the Thoracic Oncology Service at Memorial Sloan Kettering Cancer Center (MSK) and principal investigator of the study. "The use of urinary cell-free DNA to non-invasively detect tumor mutations could have multiple applications in the treatment of patients with EGFR-mutant lung cancer, including the potential to track disease burden and modify treatment at the first sign of resistance, which may improve patient outcomes."

In a prior collaborative study, clinicians at MSK demonstrated that Trovagene's urine-based precision cancer monitoring platform performed better than biopsy for the detection of BRAF mutations in patients with certain histiocytic diseases. These results were presented at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting and, as a result of the clinical utility demonstrated in the study, the technology is referenced in published Multi-Disciplinary Clinical Consensus Guidelines for histiocytic diseases. Similar to the challenges of diagnosing histiocytic disease and monitoring treatment, obtaining a sufficient biopsy in metastatic lung cancer patients can be difficult, if not impossible, in some cases. Researchers believe that if EGFR mutations can be identified and tracked accurately in a urine sample, this form of liquid biopsy could become an important tool for the management of metastatic lung cancer.

Mark Erlander, Ph.D., chief scientific officer of Trovagene stated, "Our ongoing collaboration with Memorial Sloan Kettering demonstrated the advantages of our cell-free molecular diagnostics over traditional tissue-based molecular testing in terms of mutation detection and the ability to monitor tumor dynamics over time. We are confident that our platform can help clinicians by providing timely detection and tracking of EGFR mutational status in metastatic lung cancer patients, and we look forward to working closely with Dr. Yu and her team in this investigational study."