XBiotech completed a groundbreaking double-blind, placebo controlled Phase III trial to evaluate MABp1 therapy in colorectal cancer patients. The study, which used both innovative and established objective response criteria to evaluate MABp1, grew out of collaboration between XBiotech and the Scientific Advisory Group of the European Medicines’ Agency (EMA). The regulatory path was devised around an EMA mandate to find new and better measures of efficacy for anti-tumor agents in treating patients with advanced cancer.
New clinical endpoints were developed based on findings from an earlier study where cancer patients receiving the antibody exhibited remarkable symptomatic recovery that in turn was associated with marked improvement in overall survival.
Study results showed a 76 percent relative improvement in response rate in patients treated with MABp1 compared to placebo.