Results from the VeriStrat analysis of a phase II trial of first line erlotinib in combination with sorafenib in patients with advanced non-small cell lung cancer (NSCLC) were presented today at the 22nd EORTC-NCI-AACR Symposium on Molecular Targets in Cancer Therapeutics being held in Berlin, Germany by Egbert Smit, MD, PhD of the VU Medical Center, Amsterdam, The Netherlands. The intention of the biomarker analysis was to evaluate the ability of the blood-based test, VeriStrat, to predict patient outcomes with the erlotinib plus sorafenib combination regimen.
Forty-nine of 50 patients from the study had pretreatment serum samples available for analysis. VeriStrat analysis classified 33 (67%) as likely to have “good” outcomes and 15 (31%) as likely to have “poor” outcomes. Only one sample was classified as indeterminate. VeriStrat Good patients had a significant improvement in overall survival compared with VeriStrat Poor patients (Hazard ratio= 0.30; CI: 0.12-0.74). The median overall survival for VeriStrat Good patients was 13.7 months compared to 5.6 months for VeriStrat Poor patients.
Researchers concluded that the proteomic test, VeriStrat, may identify a subset of patients that derive significant clinical benefit from first- line treatment of advanced NSCLC with dual targeted therapies. Prospective studies are planned.
“This is the first study to demonstrate that a biomarker can identify patients who are likely to benefit from the erlotinib plus sorafenib combination, “ stated Egbert Smit, MD, PhD. “This is exciting for lung cancer patients as the all-oral combination may be more tolerable than traditional platinum-based regimens, with similar efficacy. More research is needed to fully define the role of this biomarker and identify the specific groups of patients that this combination may benefit.”
About NSCLC: As reported by the American Cancer Society, lung cancer is the leading cause of cancer death in the US. NSCLC represents approximately 87% of lung cancer. An estimated 215,000 new cases of lung cancer and 162,000 deaths due to lung cancer occurred in the US in 2008. Treatment options include surgery, radiation therapy, chemotherapy and targeted biological therapies such as bevacizumab (Avastin®) and erlotinib (Tarceva®). Less than 5% of advanced NSCLC patients survive for 5 years, emphasizing the need for improved patient selection to maximize drug efficacy.
About VeriStrat: VeriStrat is a proteomic serum test for patients with advanced NSCLC. The test identifies patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors (EGFRIs). Samples are processed in Biodesix’ CLIA accredited laboratory and results are typically reported within 72 hours of sample shipment. VeriStrat has been validated in clinical studies with over 1500 patients. Biodesix is engaging in additional studies to further validate the test and to explore the clinical utility of VeriStrat in other solid epithelial tumors and with other EGFRIs. For more information on VeriStrat or to order VeriStrat, visit www.VeriStratSupport.com or call the VeriStrat Support Hotline at 1-866-432-5930.
About Biodesix: Biodesix is a fully integrated molecular diagnostic company developing products that support excellence in clinical decision making and improve patient care. The Company’s goal is to give physicians more information to understand the patient and their disease. Understanding the clinically meaningful information contained within each patient’s molecular profile leads to better care and better outcomes. The Company’s unique approach is based on ProTS® proprietary technology which exploits the power of mass spectrometry and enables the discovery of specific molecular profiles that can be used to better characterize the patient and their disease. Biodesix collaborates with investigators to address key clinical questions, and partners with biotechnology and pharmaceutical companies for development of companion diagnostics and improved targeting of therapies in clinical trials. For more information about Biodesix, please visit the Company’s website at www.Biodesix.com
This press release contains statements that are hereby identified as “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the Company’s inability to further identify, develop and achieve commercial success for products and technologies; the risk that the Company’s financial resources will be insufficient to meet the Company’s business objectives; uncertainties relating to the regulatory approval process and changes in relationships with strategic partners. We disclaim any intent or obligation to update these forward-looking statements.