Results from the VeriStrat retrospective analysis of the Phase III trial, EGF30008, were presented today at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium. The EGF30008 study compared Femara® plus placebo to Femara plus Tykerb® in 1st line, hormone receptor positive, advanced breast cancer patients. The study included both Her2 positive and Her2 negative patients. Results showed that the VeriStrat test was able to identify a group of patients who have worse progression free survival (PFS) when treated with Femara alone, independent of Her2 status.
Pretreatment serum samples from 1041 of the 1286 patients enrolled in the EGF30008 study (81%) were classified as either VeriStrat Good or VeriStrat Poor. In the Femara treatment arm, patients who tested VeriStrat Good had a median progression free survival (PFS) of 10.8 months versus patients who tested VeriStrat Poor with 2.8 months (log rank p<0.0001, HR: 0.36). The evaluation of the Femara plus Tykerb arm showed that patients who tested VeriStrat Good had a median PFS of 11.4 months versus patients who tested VeriStrat Poor with 11.0 months (log rank p=0.53). Multivariate analysis demonstrated a significant interaction between VeriStrat classification and treatment (interaction p=0.002), indicating that the VeriStrat test was predictive of a differential treatment effect between VeriStrat groups. While in the Her2 positive population both VeriStrat groups benefitted from the addition of Tykerb to Femara, interestingly in the Her2 negative population there was also a trend to a meaningful increase in PFS for patients who tested VeriStrat Poor (3.1 months vs. 11.0 months, p=0.068).
David Brunel, CEO of Biodesix commented, “We have a growing body of evidence regarding the utility of VeriStrat in multiple tumor types, but EGF30008 represents the first study to evaluate our diagnostic test in breast cancer and the first with an endocrine agent. It’s encouraging to see that our test not only identifies a group of hormone receptor positive patients with poor outcomes on endocrine therapy, but also has predictive power, showing that this group of patients can achieve similar outcomes to other patients when Tykerb is added to the treatment regimen, regardless of their Her2 status.”
About VeriStrat: VeriStrat is a serum proteomic test currently available for patients with advanced NSCLC. The test identifies patients who are likely to have good or poor outcomes after treatment with epidermal growth factor receptor inhibitors (EGFRIs). Samples are processed in Biodesix’ CLIA accredited laboratory and results are typically reported within 72 hours of sample shipment. VeriStrat has been validated in clinical studies with over 1500 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.
Femara® is a registered trademark of Novartis International AG.
Tykerb® is a registered trademark of the GlaxoSmithKline group of companies in the United States and the countries outside of Europe.
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.