Biodesix® Tests Demonstrate Ability to Stratify Patients Treated with Immunotherapy

VeriStrat^® Test Shown To Have Clinical Utility in Predicting Overall Survival of Afatinib-Treated Patients With Lung Cancer

December 13, 2016, Boulder, Colorado… Two studies demonstrating the clinical utility of the VeriStrat^® test in the management of patients with non-small cell lung cancer (NSCLC) were presented last week at the 17th World Conference on Lung Cancer, hosted by the International Association for the Study of Lung Cancer. A Biodesix investigational test developed with the Diagnostic Cortex™ platform was also evaluated in one of the studies, providing further data regarding the potential value of a proteomic test to help physicians stratify patients for immunotherapies.

During his oral presentation on December 7, study author Dr. Glenwood Goss said, “VeriStrat appears to be a robust assay and should be used for EGFR-wild-type patients with squamous cell lung cancer.” Dr. Goss is a Professor of Medicine at the University of Ottawa and an oncologist in the Division of Medical Oncology, University of Ottawa.

In the first study, LUX Lung 8, afatinib (an irreversible ErbB family blocker) was compared with erlotinib (a reversible EGFR TKI) in patients with EGFR-wildtype squamous cell carcinoma of the lung (SCC) who had progressed after at least four cycles of platinum-doublet chemotherapy[1]. In a sub-analysis of the LUX Lung 8 study, afatinib-treated patients classified as VeriStrat-Good were found to be nearly four times as likely as patients classified as VeriStrat-Poor to survive for twelve months or longer. Data reported in oral and poster presentations demonstrated that the VeriStrat test identifies a subset of patients who have significantly better outcomes on afatinib versus erlotinib; VeriStrat—Good patients experienced PFS of 3.3 months versus 2.0 months, and OS of 11.5 months versus 9 months.

In the long-term responder (LTR) subset of patients who survived at least one year, afatinib conferred a median survival benefit of nearly two years. Several possible molecular/clinical biomarkers indicative of long-term response to afatinib were evaluated, including VeriStrat status. 86% of long-term responders were VeriStrat-Good (versus 62% VeriStrat-Good in the overall afatinib-treated population). Almost 6% of VeriStrat-Good patients were LTR, versus only 1.5% of VeriStrat-Poor patients.

In a second study, “Evaluation of Pretreatment Serum Tests for Nivolumab Benefit in Patients with Non-Small Cell Lung Cancer,” previously treated patients with advanced NSCLC (both squamous and non-squamous histology) were enrolled in a single-institution translational research study. Patients in the study were treated with nivolumab, an anti-PD-1 agent, and serum samples were evaluated using both an investigational test developed for use in melanoma, and with VeriStrat testing.  Both tests were shown to be prognostic in patients treated with nivolumab, with the investigational test having superior performance.

“Immunotherapies are rapidly changing the treatment landscape in lung cancer with significant benefit to patients.   Developing the right tools to help physicians stratify patients to the appropriate therapies during the course of their treatment will be critical to extending survival, managing side effects, and controlling costs.  Our testing methodology, which measures hundreds of proteins in a single assay and then utilizes the machine learning intelligence of our Diagnostic Cortex is uniquely suited to characterizing different immune states and tumor immune escape strategies over time, with the goal of enabling physicians to provide advanced precision medicine.   Our work presented at the Society for Immunotherapy in Cancer and at the World Lung Cancer Conference is indicative of where we are headed with our research and value we intend to bring to treating patients,” said David Brunel, Chief Executive Officer of Biodesix.

About Biodesix
Biodesix^® is a molecular diagnostics company advancing the development of innovative blood tests in oncology to enable precision medicine. Biodesix discovers, develops and commercializes multivariate protein and genomic diagnostic blood tests, including the GeneStrat^® and VeriStrat^® tests, that deliver results within 72 hours. The company is changing the standard of care by providing physicians with diagnostic tests for better therapeutic guidance, more accurate prognosis and enhanced disease monitoring to improve patient outcomes. At the forefront of precision medicine, Biodesix is developing new blood tests to identify patients who may benefit from immunotherapies. In addition to developing novel diagnostics independently, the company partners with biotechnology and pharmaceutical companies to develop companion diagnostics for use with therapeutic agents.