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Thursday, December 13, 2018

XBiotech announces post-hoc analysis for bermekimab study published


XBiotech announced the publication of findings on key biomarker analysis of colorectal cancer patients treated with bermekimab in its European Phase III study. The manuscript has been published online in the journal OncoImmunology. The findings report that patients with relatively low levels of IL-1ra or IL-6 were more likely to respond to bermekimab therapy and achieve the study’s primary endpoint. The study’s primary endpoint measured a combination of physical symptoms-pain, fatigue, anorexia and muscle wasting-which tend to worsen with advanced cancer, to assess whether these symptoms stabilized or improved with treatment. Patients that achieved the primary endpoint in the Phase III study had one-fifth as many serious adverse events, were twice as likely to have no tumor growth, improved significantly with all life quality measures, and had almost three-fold increase in survival compared to failures. Results from analysis found that for patients with relatively low IL-1ra levels at the start, 41% of those treated with bermekimab achieved the primary endpoint, compared to only 33% of patients for the entire bermekimab treatment group. However, in the publication it is reported that for those with relatively low pretreatment levels of both IL-1ra and IL-6, 46% of patients in the bermekimab group versus only 17% in placebo achieved the primary endpoint. About 28% of patients in the study met the criteria of low IL-1ra and low IL-6.

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