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Biodesix, Inc.. (9/27/16). "Press Release: Biodesix’ VeriStrat Test Identifies T790M-Mutated Advanced Non-Small Cell Lung Cancer Patients Who Are More Likely to Have Improved Progression-Free Survival on Third Generation EGFR-TKI Therapy".

Organisations Organisation Biodesix Inc.
  Organisation 2 International Association for the Study of Lung Cancer (IASLC)
Product Product VeriStrat® MS-based proteomic blood test

Blood-based proteomic test helps identify NSCLC patients for EGFR-TKI therapy

Combined results from subset analyses of the TIGER-X and TIGER-2 clinical trials show that the VeriStrat test stratifies T790M-mutated patients with previously-treated, advanced non-small cell lung cancer (NSCLC) who are more or less likely to experience longer progression-free survival (PFS) when treated with a third-generation EGFR-TKI therapy. Clinical trial data suggesting the test’s potential for identifying better candidates for third-generation EGFR-TKI therapy were presented in Chicago last Friday at the at the IASLC Multidisciplinary Symposium in Thoracic Oncology hosted by the International Association for the Study of Lung Cancer.

The VeriStrat® Test

Biodesix’ VeriStrat test is a predictive and prognostic blood-based proteomic test for patients with advanced NSCLC. The test is used to assess disease aggressiveness by characterizing host response to the tumor, classifying patients as either VeriStrat-Good (VS-G) or VeriStrat-Poor (VS-P). The test has previously been shown to predict survival outcomes for patients with advanced NSCLC treated with erlotinib . VeriStrat test results are available to ordering physicians within 72 hours.

The Study

EGFR mutation status is known to identify patients with NSCLC who experience significantly better outcomes on EGFR-TKI therapy versus standard platinum-doublet therapy in a front line setting . However, a subset of patients will have de novo resistance, and acquired resistance is expected for all patients. The EGFR T790M mutation is the mechanism of resistance at progression in as many as 60% of patients. All patient samples in the cohort analyzed by the VeriStrat test were centrally confirmed T790M mutation-positive by tissue testing prior to enrollment in the TIGER-X or TIGER-2 clinical trials. VS-G or VS-P results were obtained for 230 patient samples, and the post hoc analysis examined clinical outcomes with respect to the VeriStrat® status.

Study Results

The patient population who had VeriStrat test results had a median progression-free survival of 127 days (163 events/232 patients with VeriStrat test results). Additionally, PFS was analyzed for patients who had ECOG status of 0 (63 patients; median 169 days) or 1 (169 patients; 125 days) and was found to have a hazard ratio of 0.85 (p-value 0.37). Analyses were performed comparing VeriStrat test status Good and Poor for the entire T790M mutation positive patient pool; for 2nd line patients alone; and for 3rd and higher line patients alone. For the entire cohort, median PFS was 168 days for the VS-G patients versus 91 days for VS-P patients; for the 2nd line cohort, median PFS was 127 days for VS-G patients versus 43.5 days for VS-P patients; for the 3rd and higher lines cohort, median PFS was 165 days for VS-G patients versus 106 days for VS-P patients.

An additional analysis was performed investigating VeriStrat test status versus ECOG performance status. For ECOG status 1 patients, VeriStrat further stratified patients by median PFS:153 days for VS-G patients versus 102 days for VS-P patients. The hazard ratio was 0.50 (p-value 0.0002). These data are the first reported results from the VeriStrat test on advanced NSCLC patients who are T790M mutation-positive.

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.

1. Gregorc, Vanesa et al. “Predictive Value Of A Proteomic Signature In Patients With Non-Small-Cell Lung Cancer Treated With Second-Line Erlotinib Or Chemotherapy (PROSE): A Biomarker-Stratified, Randomised Phase 3 Trial”. The Lancet Oncology 15.7 (2014): 713-721

Fukuoka, Masahiro, et al. “Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non–small-cell lung cancer in Asia (IPASS).” Journal of Clinical Oncology29.21 (2011): 2866-2874.

Fukuoka, M., Wu, Y. L., Thongprasert, S., Sunpaweravong, P., Leong, S. S., Sriuranpong, V., … & Duffield, E. L. (2011). Biomarker analyses and final overall survival results from a phase III, randomized, open-label, first-line study of gefitinib versus carboplatin/paclitaxel in clinically selected patients with advanced non–small-cell lung cancer in Asia (IPASS). Journal of Clinical Oncology, 29(21), 2866-2874.

Record changed: 2018-02-20


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