XBiotech said Oct. 19 that 49 of 80 evaluable patients given vilamakitug were alive at 12 months in the Phase II portion of TASKIN, exceeding the company’s stated survival threshold for advanced colorectal cancer.
The survivors represented 61.3% of evaluable patients, above the 42-person threshold XBiotech said the study had set. In the placebo group, 44 of 79 patients, or 55.7%, were alive at the same point. XBiotech said both groups received trifluridine/tipiracil, with or without bevacizumab.
The protocol published by TASKIN investigators describes the trial as randomized, double-blind and noncomparative, and identifies six-month overall survival as the Phase II primary endpoint. XBiotech described its 12-month threshold as prespecified, but that status is unverified against the published protocol. The company’s release did not explain the difference or report an overall-survival hazard ratio or statistical test comparing all patients in the two groups. The reported counts alone therefore do not establish a survival advantage across the full study population.
XBiotech reported median progression-free survival of 5.9 months with vilamakitug and 5.6 months with placebo, with a p value of 0.42. In an exploratory analysis of 37 patients with right-sided primary tumors, the company reported a 0.38 hazard ratio for death through 12 months, with a 95% confidence interval of 0.14 to 0.99 and a Cox p value of 0.047. The announcement did not give the subgroup’s patient count in each arm.
TASKIN is an investigator-sponsored French study of vilamakitug, also known as XB2001. XBiotech describes the investigational antibody as targeting interleukin-1 alpha. The French National Cancer Institute (INCa) lists Centre Georges-François Leclerc as the trial sponsor. Professor François Ghiringhelli, TASKIN’s principal investigator, said patients whose cancer has resisted treatment have few options and poor survival prospects.
XBiotech said the right-sided tumor result will guide further development of vilamakitug. It gave no date for another trial or regulatory decision; the exploratory finding will need confirmation in further study.
