XBiotech Announces Data From Its Phase II Portion Of Multicenter TASKIN Clinical Study Meets Pre-Specifed Primary Efficacy Success Criterion Under Simon Two-Stage Design; 61.3% Participants In Vilamakitug Experimental Arm Were Alive, Surpassing Threshold Of 42, More Surviving Patients

XBiotech Inc. (NASDAQ: XBIT) today announced positive final efficacy results from the randomized Phase II portion of the multicenter TASKIN clinical trial. The investigator-sponsored study—funded by the French National Cancer Institute (INCa) and coordinated by investigators at the Centre Georges-François Leclerc (CGFL) in Dijon, France—evaluated the addition of XBiotech’s anti-IL-1α monoclonal antibody, XB2001 (Natrunix™, vilamakitug), to standard-of-care trifluridine/tipiracil (TAS-102) with or without bevacizumab in patients with refractory metastatic colorectal cancer (mCRC).

The TASKIN Phase II study met its pre-specified primary efficacy success criterion under a Simon two-stage design. At the 12-month landmark analysis, 49 of 80 evaluable patients (61.3%) in the vilamakitug experimental arm were alive, surpassing the protocol-defined threshold of 42 or more surviving patients required to establish efficacy. In the control arm (placebo plus standard chemotherapy), 44 of 79 evaluable patients (55.7%) were alive at 12 months.