Results from VeriStrat biomarker analysis of Phase III trial presented at European Lung Cancer Conference

May 3 2010

Results from the VeriStrat biomarker analysis of a multicenter Phase III trial were presented today at the 2nd European Lung Cancer Conference currently being held in Geneva, Switzerland.  Results showed that the VeriStrat test identified patients who were likely to have a survival benefit from treatment with erlotinib, a commonly prescribed oral therapy for advanced non-small cell lung cancer (NSCLC).  Following treatment with erlotinib, patients in the group classified as "VeriStrat Good" had a median survival of 10.5 months compared to 4.0 months in the group classified as "VeriStrat Poor."

The study retrospectively applied the VeriStrat proteomic analysis to a subset of the patient population from the NCIC Clinical Trials Group study BR.21, a Phase III, multicenter trial of erlotinib versus placebo in previously treated patients with NSCLC. The VeriStrat analysis involved 441 of 729 patients from the BR.21 study and classified patients as either "VeriStrat Good" or "VeriStrat Poor" based on a proteomic profile.  The data suggest that with a VeriStrat Good classification a patient is likely to receive therapeutic benefit from treatment with erlotinib and with a VeriStrat Poor classification, a patient is likely to derive little therapeutic benefit.  

VeriStrat Good patients treated with erlotinib had a significant improvement in survival of 10.5 months compared to 6.6 months on placebo (hazard>

"The era of personalized medicine requires that we can have biomarkers to select therapy, that these can be easily obtained, and that the results are available in a short time frame.   Analysis of a serum protein profile such as VeriStrat meets these criteria," stated Paul Bunn, MD, James Dudley Chair in Cancer Research at the University of Colorado Denver.  "Several therapies such as erlotinib, docetaxel or pemetrexed are approved in either the maintenance setting, the 2nd or 3rd line setting or both and it has been difficult to determine which of these therapies might be best for an individual, especially an individual without an EGFR mutation. The data presented suggest that a positive VeriStrat test can pick those patients most likely to benefit from erlotinib."

SOURCE Biodesix