The results of a phase 1 pharmacokinetic and safety equivalence study demonstrated equivalence between HD204 and both bevacizumab-EU and bevacizumab-US in healthy males.
A single-blind, single-dose, randomized, 3-arm, parallel-group phase 1 study (SAMSON) was conducted to confirm pharmacokinetic and safety equivalence between bevacizumab and HD204, a candidate biosimilar to bevacizumab, in healthy males. These results were reported at the 2020 American Society of Clinical Oncology Virtual Scientific Program.
A total of 120 healthy males were included in the study. Enrolled subjects were randomized 1:1:1 to receive either HD204, bevacizumab licensed in the European Union (bevacizumab-EU), or bevacizumab approved in the United States (bevacizumab-US) at a dose of 1 mg/kg administered by intravenous infusion. Comparative assessments included pharmacokinetic parameters, safety, including adverse events, incidence of antidrug antibodies, and neutralizing antibodies.
Pharmacokinetic equivalence was established between HD204 and both bevacizumab-EU and bevacizumab-US, based on comparable results from pairwise comparisons of pharmacokinetic parameters, including exposure (area under the plasma drug concentration–time curve [AUC] to infinity and AUC up to the last quantifiable time point), maximal concentration, half-life, clearance, and volume of distribution. Treatment-related adverse events were comparable between HD204 and the 2 bevacizumab reference groups; the incidence of treatment-related adverse events was 25.0% in HD204 group, 30.0% in the bevacizumab-EU group, and 25.6% in the bevacizumab-US group. There were no treatment-emergent serious adverse events. In terms of immunogenicity, subjects who received HD204 did not develop antidrug antibodies.
Based on these results, it was concluded that HD204 demonstrated equivalence to both bevacizumab-EU and bevacizumab-US in terms of pharmacokinetics and safety in healthy male subjects.
Reference
Hii J, et al. ASCO 2020. Abstract e21556.