Abbisko Therapeutics announced that it has completed first patient dosing in a registrational study of irpagratinib, a self-developed and highly-selective small molecule FGFR4 inhibitor, for the treatment of Hepatocellular Carcinoma (HCC).

In May, irpagratinib received Breakthrough Therapy Designation from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). It is the first therapeutic agent to utilize molecularly defined biomarkers for precision-targeted treatment of HCC.

The vast majority of patients with advanced HCC treated with current standard-of-care therapies—including immune checkpoint inhibitors (ICIs) and multi-targeted kinase inhibitors (mTKIs)— experience disease progression within one year. Additionally, approximately 30% of HCC patients exhibit FGF19 overexpression, a biomarker associated with more aggressive tumor biology and poorer prognosis. The registrational study of irpagratinib (ABSK-011-205) is a multi-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the efficacy and safety of irpagratinib in combination with Best Supportive Care (BSC) versus placebo in combination with BSC, in patients with advanced or unresectable HCC who exhibit FGF19 overexpression and have previously been treated with ICIs and mTKIs. Eligible patients will be randomized in a 2:1 ratio to receive irpagratinib or placebo.