Press Release
XBiotech Reports Additional Positive Data From Phase III European Trial of Xilonix™ in Advanced Colorectal Cancer
In addition to previously announced positive results regarding the primary endpoint of the pivotal study, complete data analysis further demonstrated that key secondary measures of antibody activity were also improved. Inhibition of IL-1 alpha on the surface of platelets may represent an important anti-tumor, disease-modifying activity, due to the mechanism of action of Xilonix. In the study, median platelet counts among placebo patients were found to be increased 5-fold compared to patients who received Xilonix, whose platelet counts remained near baseline levels during the treatment cycle (p=0.003).
Furthermore, while the study was not powered to demonstrate differences in serious adverse events (SAEs) between treatment and placebo groups, there was a 26% reduction in the risk of SAEs in the treatment arm relative to placebo (p=0.062). A treatment-related reduction in SAEs compared to placebo patients is a remarkable and important finding. An SAE is defined as a health-related event that is life-threatening, results in persistent or significant disability, or death. This may be the first report of a placebo controlled, randomized clinical study of an anticancer agent where there was reduced incidence of SAEs in a treatment arm. Finally, patients in the treatment arm were found to be 53% more likely to have stable disease compared to placebo at eight weeks (p=0.12).
The trends toward reduced disease progression and a reduction in SAEs is compelling given the small patient population in the study. Together, the Company believes that these secondary findings corroborate the therapeutic value of the antibody in advanced, recalcitrant cancer.
The study included only patients with advanced disease with multiple symptoms that were prognosticators of poor outcome. The study was thus performed on a narrowly defined group of patients living with advanced colorectal cancer. The objective response criteria that constituted the primary endpoint were based on findings of a previous study in advanced cancer patients where antibody therapy was associated with recovery from key disease-related symptoms, including objective findings of increased lean body mass (LBM), and recovery from appetite loss, fatigue and pain. The Company collaborated with the
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