$XBIT: XBiotech presents Phase 3 data for Xilonix
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Co presented positive results from a pivotal Phase III trial of Xilonix, the company's lead monoclonal antibody immunotherapy for the treatment of advanced colorectal cancer.
In the study, Xilonix-treated patients with advanced disease and multiple symptoms known to inversely correlate with overall survival experienced a 76% relative increase in clinical response rate, a novel measure of anti-cancer activity, after 8 weeks of therapy compared to placebo (33% vs. 19%). In addition, clinical response correlated with improved overall survival. Among responders (in both treatment and placebo arms), clinical response was associated with a 2.7-fold increase in overall survival (11.5 versus 4.2 months in responders vs. non-responders, respectively). Overall survival was not compared between treatment arms because after 8 weeks, all patients were eligible to receive study drug. Treatment with Xilonix was well tolerated, with an adverse event profile comparable to placebo.