FDAnews
www.fdanews.com/articles/174455-xbiotechs-advanced-colorectal-cancer-candidate-meets-primary-endpoint

Xbiotech’s Advanced Colorectal Cancer Candidate Meets Primary Endpoint

December 11, 2015

XBiotech’s advanced colorectal cancer therapy Xilonix met primary endpoints of improvement in lean body mass and quality of life in a European Phase 3 trial.

Roughly 33 percent of patients on the study drug saw improvements compared to 19 percent on placebo. Patients with refractory, metastatic colorectal cancer who suffered from cancer-associated symptoms such as fatigue, pain, elevated inflammatory markers, weight loss and reduced physical ability at baseline participated in the study. The endpoints were quantified by X-ray imaging and assessed based on patient-reported outcomes.

A therapeutic antibody, the biologic works by blocking inflammation believed to support tumor growth.