Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, today announced the launch of a study that aims to determine utility of the Company's Precision Cancer Monitoring℠ (PCM) technology for predicting response to treatment in advanced melanoma patients receiving one or a combination of the novel immunotherapy agents Yervoy® (ipilumumab), a CTLA-4 inhibitor, and Opdivo® (nivolumab), a PD-1 inhibitor. The 50-patient study will be led by researchers at Memorial Sloan Kettering Cancer Center (MSK). BRAF and NRAS oncogene mutations will be used as biomarkers to monitor tumor dynamics in treated patients. Primary objectives of the study include determining 1) if circulating tumor (ctDNA) can determine response to therapy early, and 2) if ctDNA results correlate with the clinical course of disease.
The need to quantitatively monitor early response to cancer immunotherapy is widely recognized given the lack of response biomarkers, toxicities with combination immunotherapy, and the challenge of pseudo-progression, which is characterized by initial tumor swelling that is observed with traditional imaging tools.
"As more immunotherapies become available for the treatment of cancer, it becomes more important to have non-radiographic tools to assess treatment effects," stated Paul Chapman, M.D., a medical oncologist at MSK who will oversee the study. "Responses to immunotherapy vary greatly in timing and extent, and radiographic responses may not reflect accurately the true response. A rapid, accurate, and quantitative method to determine therapeutic effect as early as possible could help align new treatment strategies to patients' needs."
"In this study, we attempt to better inform clinicians of the early benefits of immunotherapy in advanced melanoma," said Mark Erlander, PhD, chief scientific officer of Trovagene. "We have previously shown in lung, colorectal, and pancreatic cancers that our PCM platform can detect response to therapy within days of treatment. Here, we intend to demonstrate that quantitative monitoring of driver mutations can provide reliable insight into tumor dynamics and response to immunotherapy, which is particularly important given the shortfalls of cancer imaging in this clinical situation."
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