Press Release
XBiotech Reports Affirmative Interim Analysis of Global Phase 3 Colorectal Cancer Study
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These findings also lend support to the Company’s recently completed Phase 3 study in
According to the IDMC charter, this was the first of two interim efficacy analyses planned prior to the final analysis for overall survival. As determined based on alpha spending function of O’Brien and Fleming sequential group design (O’Brien PC, Fleming TR, 1979), survival analyses are to be performed after 276 (50%), 414 (75%) and 552 (100%) events at the respective stages. The criteria for early termination for efficacy (rejection of null hypothesis) or to accept the null hypothesis is based on the group sequential design. If the test statistics crosses the pre-specified boundaries for type I error (alpha cut-off 0.0029, 0.0121, and 0.025 at the first, second interim or final analysis, respectively) the trial will stop for efficacy. Otherwise the trial continues to the next stage.
The cumulative p value for the acceptance boundary (beta) will be 0.25 and 0.08 at the first and second interim, respectively. If efficacy is established at an interim analysis, enrollment will be stopped and the control group will be allowed to crossover. All subjects will be followed up until death, loss to follow-up, or termination of the study. The decision rule with interim monitoring was planned as follows: If type I error probability (alpha) ≤ the above specified cumulative alpha level at the given stage, trial will stop for efficacy; if the p value ≥ the above specified beta levels, the trial will stop for accepting null hypothesis; if neither of these occurs, the trial will continue to the next stage. At final analysis, if alpha is ≤0.025 then efficacy will be declared, otherwise the null hypothesis will be accepted.
Patients enrolled in the XCITE study were randomized 2:1 to receive Xilonix or placebo plus, in each case, best supportive care. Advanced colorectal cancer patients are required to have previous failed regimens that included flouropyrimidines, oxaliplatin, irinotecan, and Cetuximab (or Panitumumab for patients with KRAS mutation). Patients are expected to continue in the study until there is evidence of radiographic progression. The study may be stopped for efficacy or futility at the second remaining interim analysis, and patients are otherwise followed for up to 18 months in order to determine overall survival. The study is powered for 552 events at conclusion.
The primary endpoint of this study is overall survival, with secondary endpoints including objective response rate, progression free survival, change in lean body mass and patient reported quality of life measures.
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Unlike previous generations of antibody therapies, XBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
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ContactAshley Otero aotero@xbiotech.com 512-386-2930