XBiotech doesn’t hold out much hope that it will win European approval for its anticancer antibody therapeutic Xilonix™ as a treatment for advanced colorectal cancer, after a European Medicines Agency (EMA) committee queried the clinical relevance of the treatment.
XBiotech met with the European Medicines Agency to discuss the Day 180 List of Outstanding Issues related to its marketing authorization application (MAA) for the interleukin-1α- (IL-1α)-targeting True Human™ antibody candidate and clarify clinical data supporting the MAA. The firm said that key outstanding issues were centered on “clinical relevance of the therapy in the indication and quality assurance related matters.”
The EMA committee subsequently returned a negative trend vote, which means it is “unlikely” that the Agency’s Committee for Medicinal Products for Human Use (CHMP) will give a positive opinion at their formal vote, scheduled for next month, the firm admits.
XBiotech president and CEO, John Simard, believed the data “speak in a clear and resounding voice to clinical relevance of a new antibody therapy in advanced colorectal cancer.” He indicated that the company may appeal against the negative decision resulting from the meeting. “We believe that findings from our Phase III study show that we have developed an important endpoint and methodology to evaluate anticancer therapy in advanced-stage disease and that our monoclonal antibody represents a breakthrough treatment in patients with advanced colorectal cancer.”
Xilonix is in development as a treatment for advanced colorectal cancer patients who have metastatic or inoperable tumors and who have undergone all possible chemotherapies. EMA granted accelerated review for the Xilonix MAA in April last year, and the treatment has been granted fast track designation by the FDA. A Phase III study evaluated Xilonix in advanced colorectal cancer patients. According to XBiotech, the study’s results showed that in comparison with placebo, Xilonix treatment led to significant increases in clinical response rates, resulted in responders gaining more lean body mass, and improved control of thrombocytosis and systemic inflammation.