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Biodesix Announces Results in Phase III Lung Cancer Diagnostic Study; First Prospective Biomarker-Stratified Validation Study in Oncology

Results of independent trial confirm VeriStrat’s ability to predict differential treatment outcomes between erlotinib and chemotherapy

Biodesix, Inc., a fully integrated molecular diagnostics company dedicated to personalizing medicine, today announced results of the recently completed phase III clinical trial for its VeriStrat® test. Data confirms that the non-invasive, blood-based protein diagnostic is predictive of differential treatment outcomes between two types of therapies for second-line treatment of advanced non-small cell lung cancer: chemotherapy or the targeted drug erlotinib (Tarceva®).

The trial, called PROSE (Randomized Proteomic Stratified Phase III Study of Second Line Erlotinib versus Chemotherapy in Patients with Inoperable Non-Small Cell Lung Cancer), is the world’s first completed, prospective biomarker-stratified study in oncology to test treatment and biomarker interaction. The study’s principal investigator, Vanesa Gregorc, M.D., of the Department of Oncology at the Scientific Institute of the University Hospital San Raffaele in Milan, Italy, presented results at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

“The findings from PROSE show that the VeriStrat test provides physicians with clinically useful information helping to guide therapy for lung cancer patients in the second-line setting,” said Dr. Gregorc. “For lung cancer patients, this test offers meaningful insight into which therapy, either EGFR-TKIs or chemotherapy, is likely to lead to the best survival outcome.”

Currently, erlotinib, an EGFR-TKI, is commonly used in patients who harbor an EGFR mutation; however, only a small percentage of patients have this mutation. VeriStrat identifies patients without a known EGFR mutation, or those whose EGFR status is unknown, and who may be considered for this targeted therapy, thus giving more patients the option of taking erlotinib instead of chemotherapy — a choice that may result in a better quality of life during advanced stages of cancer. Likewise, VeriStrat helps rule out the roughly 30 percent of patients who are highly unlikely to benefit from erlotinib and should receive chemotherapy.

“We are encouraged by the results of the PROSE study. This prospective study provides the gold standard of clinical validation confirming VeriStrat’s predictive utility in treating lung cancer patients,” said David Brunel, CEO of Biodesix. “We are in the process of completing numerous additional studies that will further expand the utility of VeriStrat in clinical decision making.”

Study Findings
PROSE is a multi-center randomized proteomic stratified phase III study of 285 study patients with advanced non-small cell lung cancer. Patients were stratified by ECOG-PS, smoking status, and blinded pre-treatment VeriStrat classification. They were then randomized 1:1 to receive erlotinib or chemotherapy at standard doses.
The results show that patients classified as “VeriStrat Poor” have better survival outcomes on chemotherapy versus erlotinib and that patients classified as “VeriStrat Good” have similar survival outcomes when treated with erlotinib or chemotherapy.

The trial reached its primary objective of showing significant interaction between treatment outcome and VeriStrat classification with an interaction p-value of 0.037. The results confirm that VeriStrat status is predictive of differential overall survival benefit for erlotinib versus chemotherapy in a second-line setting, complementing the results from a retrospective study published in the April 2013 edition of the Journal of Thoracic Oncology. For more information, visit www.veristratsupport.com or visit us at ASCO Booth #24090.

About Biodesix
Biodesix is a molecular diagnostics company advancing the development of innovative products for personalizing medicine. The company provides physicians with diagnostic tests for earlier disease detection, more accurate diagnosis, disease monitoring and better therapeutic guidance which may lead to improved patient outcomes. Biodesix discovers,develops, and commercializes multivariate protein diagnostics based on their proprietary mass spectrometry based discovery platform, ProTS®. VeriStrat, a multivariate serum protein test, is Biodesix’ first product developed with ProTS. The commercially available test provides oncologists with information to help them select between erlotinib and single-agent chemotherapy for advanced lung cancer patients. VeriStrat has been studied in over 80 clinical trials and ordered for over 5000 patients. Tests are processed in Biodesix’ CLIA-certified laboratory and results are reported in less than 72 hours. In addition to developing novel diagnostics independently, the company also partners with biotechnology and pharmaceutical companies to develop companion diagnostics to improve utility of therapeutic agents. For more information on VeriStrat, please visit www.VeriStratSupport.com. 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.

Tarceva® is a trademark of OSI Pharmaceuticals, LLC, an affiliate of AstellasPharma US, Inc., and Genentech, Inc.

Media Contacts:
Chempetitive Group for Biodesix
Kelly Quigley or Rachel Lear

For Customer Support, call: (866) 432-5930

Topics: ASCO, biomarker, blood-based cancer test, blood-based protein diagnostic, cancer diagnostics, chemotherapy, clinical trial, EGFR, EGFR-TKIs, Erlotinib, personalized medicine, Press Releases, PROSE, Veristrat, liquid biopsy, lung cancer, molecular diagnostic, Non-Small Cell Lung Cancer, NSCLC, oncology