Data Published in Journal of Thoracic Oncology
A new study published online ahead of print in the Journal of Thoracic Oncology concludes that Biodesix’ VeriStrat test was predictive of survival outcomes between erlotinib and gemcitabine. The study, “A Retrospective Analysis of VeriStrat Status on Outcome of a Randomized Phase II Trial of First-Line Therapy with Gemcitabine, Erlotinib, or the Combination in Elderly Patients (Age 70 Years or Older) with Stage IIIB/IV Non–Small-Cell Lung Cancer” was conducted by lead investigators at the University of North Carolina Lineberger Comprehensive Cancer Center and Biodesix. This is the fourth VeriStrat study to be published in this prestigious medical journal. The paper was also the subject of an oral presentation at the 2012 Chicago Multidisciplinary Symposium in Thoracic Oncology.
VeriStrat is a novel, multivariate serum protein test that helps oncologists to effectively personalize therapy. The new study, which will appear in the April 2013 issue of the Journal of Thoracic Oncology, concludes that in this population, patients with VeriStrat Poor status should not receive erlotinib therapy but may be good candidates for gemcitabine treatment.
In the retrospective analysis — conducted by Thomas Stinchcombe, MD, Associate Professor at the UNC Lineberger Comprehensive Cancer Center, and his colleagues — 105 patients received VeriStrat testing on serum or plasma samples taken prior to initiation of therapy. Sixty-three (60%) of these samples were classified as “VeriStrat Good” and 35 samples (33%) were classified as “VeriStrat Poor.”
In the gemcitabine-treated arm, results showed no significant difference between patients classified as VeriStrat Good and VeriStrat Poor, as measured by progresssion free survival (PFS) and overall survival (OS). However, in the erlotinib treated arm, patients classified as VeriStrat Good had a statistically significant improvement in PFS (p=0.002) and OS (p=0.014) compared with patients classified as VeriStrat Poor. Patients classified as VeriStrat Good also had better PFS (p=0.027) and a strong trend toward better OS outcomes (p=0.051) in the erlotinib plus gemcitabine arm compared to patients classified as VeriStrat Poor.
Researchers concluded in multivariate analysis that the VeriStrat test was predictive of both PFS and OS outcomes between the erlotinib and gemcitabine arms ( p<0.001, p=0.017, respectively) and that further studies utilizing VeriStrat to select more beneficial treatment regimens for lung cancer patients are warranted.
“These study results are consistent with other VeriStrat data; across multiple studies; patients classified as VeriStrat Poor consistently have worse outcomes on erlotinib therapy than patients classified as VeriStrat Good,” said Dominic Spinella, PhD, Vice President of Clinical Development and Medical Affairs at Biodesix. “Importantly, this is the first study where we have identified a viable treatment option for elderly lung cancer patients with VeriStrat Poor classification: single agent chemotherapy with gemcitabine. We are pleased that this publication will add to the body of literature validating VeriStrat’s clinical utility and to continue researching therapies that benefit this group of patients.”
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.
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