Key insights
- XBiotech Inc. announced its Phase II TASKIN clinical trial for its cancer drug XB2001 (vilamakitug) met its primary efficacy endpoint. The trial, evaluating the drug combined with standard chemotherapy in patients with refractory metastatic colorectal cancer, showed 61.3% survival at 12 months in the experimental arm, exceeding the protocol-defined threshold. An exploratory analysis also indicated a significant reduction in the risk of death for patients with right-sided primary tumors treated with vilamakitug.
AUSTIN, Texas - XBiotech Inc. (NASDAQ:XBIT) announced today that its Phase II TASKIN clinical trial met its primary efficacy endpoint, with 61.3% of patients in the experimental arm surviving at 12 months.
The investigator-sponsored study, funded by the French National Cancer Institute and coordinated by Centre Georges-François Leclerc in Dijon, France, evaluated XBiotech’s anti-IL-1α monoclonal antibody XB2001 (vilamakitug) combined with standard chemotherapy in patients with refractory metastatic colorectal cancer.
The trial enrolled 159 evaluable patients randomized to receive either vilamakitug or placebo plus standard-of-care trifluridine/tipiracil with or without bevacizumab. At 12 months, 49 of 80 patients (61.3%) in the vilamakitug arm were alive, surpassing the protocol-defined threshold of 42 patients required to establish efficacy. The control arm showed 44 of 79 patients (55.7%) alive at 12 months.
Median progression-free survival was 5.9 months for the vilamakitug arm versus 5.6 months for the control arm, with a 12-month progression-free survival rate of 25.0% versus 21.0%.
An exploratory analysis of patients with right-sided primary tumors showed a 62% reduction in risk of death for the vilamakitug group compared to control, with a hazard ratio of 0.38 and a p-value of 0.047. This subgroup comprised 37 patients.
Professor François Ghiringhelli, principal investigator of the TASKIN study, stated that the results provide evidence that targeting IL-1α plays a role in tumor biology.
The drug demonstrated a 96.4% mean compliance rate with chemotherapy and only a 1.3% permanent discontinuation rate, according to the press release statement.
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