VeriStrat® Test Predicts Differential Treatment Benefit between Erlotinib Therapies for Lung Cancer Patients

BOULDER, Colo. and CHICAGO, Sept. 6, 2012 /PRNewswire/ -- Results from the VeriStrat analysis of serum samples taken from a Phase II study evaluating erlotinib plus high-dose celecoxib (E+C) or erlotinib plus placebo (E+P)  in advanced non-small cell lung cancer (NSCLC) patients were presented today  at the Chicago Multidisciplinary Symposium  in Thoracic Oncology.  Investigators concluded from retrospective analysis that the VeriStrat test may identify a group of patients who lack the epidermal growth factor receptor (EGFR) mutation that may benefit from the addition of COX-2 inhibitor celecoxib to the EGFR targeted therapy, erlotinib.

Data were presented by Karen Reckamp, MD, Associate Professor of Medical Oncology at the City of Hope Comprehensive Cancer Center.  VeriStrat testing was performed on pretreatment serum samples from 96 study patients with classifications of 69 as VeriStrat Good (72%) and 26 as VeriStrat Poor (27%).   Overall results showed that in the E+C arm,  patients classified as VeriStrat Good had significantly longer progression free survival (PFS),p <0.0001, and overall survival (OS), p<0.0001,  than patients classified as VeriStrat Poor.  In the E+P arm, no difference was seen in  PFS, yet patients classified as VeriStrat Good had a significantly longer OS than patients classified as VeriStrat Poor, p=0.001.  Importantly, in subgroup analysis, results showed patients who were EGFR mutation negative and tested VeriStrat Good had a significant improvement in progression free survival when treated with erlotinib plus celecoxib versus erlotinib alone, p = 0.035. 

Multivariate analysis indicated that the VeriStrat test was predictive of PFS outcomes depending on treatment (interaction p=0.002). Researchers concluded that further studies with the E+ C combination in a VeriStrat Good selected population are warranted. 

Dominic Spinella, PhD, Vice President of Clinical Development and Medical Affairs at Biodesix commented "This is the second study presented this week demonstrating the ability of VeriStrat to predict differential treatment outcomes for different therapy regimens.  In addition, the subgroup analysis showed that in a patient population generally considered to not benefit from erlotinib therapy, VeriStrat identifies a group that may actually benefit from the combination of erlotinib with celecoxib.  We look forward to continued VeriStrat research with this drug combination."

For more information about this study or VeriStrat, visit our website www.biodesix.com.

About VeriStrat
VeriStrat is a blood-based test for patients with cancer that provides fast, clear results on the patient's proteomic profile.  The test helps physicians make more informed treatment decisions by identifying patients who are likely to have good or poor outcomes after treatment with specific cancer therapies. Samples are processed in Biodesix' CLIA-certified laboratory and results are reported in less than 72 hours.  VeriStrat has been validated in clinical studies with over 2500 cancer patients.  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 personalized medicine company focused on the development of diagnostic products that inform treatment decisions and improve patient care.  The Company's goal is to give physicians more information about 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. Biodesix collaborates with clinical investigators to address critical clinical questions, and partners with biotechnology and pharmaceutical companies to develop diagnostics to select patients most likely to benefit from novel therapies. For more information about Biodesix, please visit 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.

SOURCE Biodesix