Biocept, Inc. has announced the initiation of a collaborative study with MedStar Georgetown University Hospital to evaluate resistance biomarkers in patients diagnosed with non-small cell lung cancer (NSCLC) who are currently being treated with EGFR inhibitors or chemotherapy. Tumors from patients with advanced NSCLC are routinely screened for the presence of EGFR mutations, with these mutations occurring in approximately 10 to 20 percent of NSCLC patients.
The study is being conducted at the Georgetown Lombardi Comprehensive Cancer Center under the direction of Giuseppe Giaccone, MD, PhD, Associate Director for Clinical Research for the MedStar Health Cancer Network's Washington Region and an internationally recognized expert in the field of lung cancer and developmental therapeutics. Biocept will monitor various clinically validated biomarkers in patients with lung cancer, including EGFR, MET, ALK and BRAF, using its proprietary circulating tumor cell (CTC) and cell free circulating tumor DNA (ctDNA) dual platform technology.
Data from the study is expected to further build and strengthen the clinical utility for Biocept's blood-based biomarker testing platforms. “Studying various forms of resistance mechanisms allows us to further expand upon and develop evidence supporting the utility of clinically actionable personalized treatment information for patients with metastatic lung cancer,” said Veena Singh, MD, Biocept's Senior Vice President and Senior Medical Director.
“Treatment with currently approved targeted TKI therapies have known benefits for patients with various EGFR activating mutations; however, nearly all of these patients will eventually develop resistance to their therapies, which results in disease progression.”
“Our study is focusing on identifying active evolving resistance mechanisms through blood-based testing in order to monitor the mutations in the tumor and importantly identify real-time treatment options for these patients,” added Dr. Singh. “We are delighted to be collaborating on this study with highly respected Dr. Giaccone and a top-tier institution such as MedStar Georgetown.”
“Current standard of care is to use tumor biopsies by invasive surgical techniques or interventional radiology to both re-stratify patients with NSCLC when signs of progression are identified and to monitor these patients for key mechanisms of resistance,” said Dr. Giaccone. “These biopsies have a quantifiable rate of complications and risk. The ability to identify resistance mechanisms through blood-based liquid biopsy monitoring allows for detection and analysis without the need to obtain more tissue.”