An independent data monitoring committee recommended the early termination of XBiotech Inc.'s phase 3 trial of Xilonix, its antibody therapy for the treatment of colorectal cancer, or colon cancer.
The committee made the recommendation because the study's findings were not enough to meet efficacy or the threshold for continuation, which involved a prospectively defined acceptance boundary for the interim analysis.
For the study, patients were randomized to receive Xilonix or placebo plus, in each case, best supportive care. Primary endpoint of the study was overall survival, with secondary endpoints including objective response rate, progression-free survival, change in lean body mass and patient-reported quality of life measures.
President and CEO John Simard said the company plans to analyze the data extensively to further understand the primary and secondary endpoint data, as well as to identify populations that may have benefited from the therapy. He stated that the findings will not impact efforts to pursue approval of the therapy based on the successful completion of the European study, which demonstrated control of debilitating symptoms in colorectal cancer.
Recently, the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a negative opinion of Xilonix.