BOULDER, Colo. and CHICAGO, today announced that -- Results from the VeriStrat analysis of serum samples taken from a Phase II study evaluating erlotinib plus high-dose celecoxib (E+C) or erlotinib plus placebo (E+P) in advanced non-small cell lung cancer (NSCLC) patients were presented today at the Chicago Multidisciplinary Symposium in Thoracic Oncology. Investigators concluded from retrospective analysis that the VeriStrat test may identify a group of patients who lack the epidermal growth factor receptor (EGFR) mutation that may benefit from the addition of COX-2 inhibitor celecoxib to the EGFR targeted therapy, erlotinib.
Data were presented by Karen Reckamp, MD, Associate Professor of Medical Oncology at the City of Hope Comprehensive Cancer Center. VeriStrat testing was performed on pretreatment serum samples from 96 study patients with classifications of 69 as VeriStrat Good (72%) and 26 as VeriStrat Poor (27%).
Overall results showed that in the E+C arm, patients classified as VeriStrat Good had significantly longer progression free survival (PFS),p <0 .0001=".0001" a="a" alone="alone" analysis="analysis" and="and" arm="arm" as="as" celecoxib="celecoxib" classified="classified" difference="difference" e="e" egfr="egfr" erlotinib="erlotinib" free="free" good="good" had="had" importantly="importantly" improvement="improvement" in="in" longer="longer" mutation="mutation" nbsp="nbsp" negative="negative" no="no" os="os" overall="overall" p="0.035. </p" patients="patients" pfs="pfs" plus="plus" poor.="poor." poor="poor" progression="progression" results="results" seen="seen" showed="showed" significant="significant" significantly="significantly" subgroup="subgroup" survival="survival" tested="tested" than="than" the="the" treated="treated" veristrat="veristrat" versus="versus" was="was" were="were" when="when" who="who" with="with" yet="yet">
Multivariate analysis indicated that the VeriStrat test was predictive of PFS outcomes depending on treatment (interaction p=0.002). Researchers concluded that further studies with the E+ C combination in a VeriStrat Good selected population are warranted.
Dominic Spinella, PhD, Vice President of Clinical Development and Medical Affairs at Biodesix commented "This is the second study presented this week demonstrating the ability of VeriStrat to predict differential treatment outcomes for different therapy regimens. In addition, the subgroup analysis showed that in a patient population generally considered to not benefit from erlotinib therapy, VeriStrat identifies a group that may actually benefit from the combination of erlotinib with celecoxib. We look forward to continued VeriStrat research with this drug combination."
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