Proposed Bevacizumab Biosimilar, HD204, Meets Primary End Point in Phase 1 Study

Singapore-based Prestige BioPharma announced this week that HD204, a proposed biosimilar bevacizumab product referencing Avastin, met its primary end point in a phase 1 study evaluating the pharmacokinetics (PK), safety, and immunogenicity of the biosimilar in comparison to its reference.

The study, SAMSON-1, sought to establish pairwise PK similarity among the proposed biosimilar, US-licensed Avastin, and EU-licensed Avastin. In total, 119 healthy male volunteers were randomized to receive a single dose of the study drug and were monitored for 71 days.

The primary end point was the area under the concentration curve from time zero to infinity (AUC_0—inf). The prespecified bioequivalence margin for the 90% CI of the ratio of the geometric means for the primary PK parameter in each comparison was 80% to 125%.

According to Prestige, the 90% CIs for the ratio of the geometric means for each comparison fell within the prespecified margin, demonstrating PK equivalency of the biosimilar and the 2 reference products. Additionally, the 3 drugs demonstrated equivalency of secondary PK parameters: maximum observed concentration and AUC from time zero to the last observed quantifiable concentration.

No notable differences were observed among the 3 arms with respect to vital signs, electrocardiogram results, or laboratory tests, and no new safety signals were observed. No patients developed antidrug antibodies in the biosimilar arm.

Prestige’s chief executive officer, Lisa Park, PhD, said in a statement announcing the results that the topline data reflect Prestige’s “commitment to providing millions of patients with greater access to high-quality, safe, affordable treatment. We also look forward to further progress in the phase 3 global clinical study of HD204.”

The SAMSON-2 study, which is ongoing, will compare the biosimilar to the EU-licensed reference bevacizumab, and will assess the biosimilar’s efficacy, safety, PK, and immunogenicity in patients with metastatic or recurrent non-squamous non-small cell lung cancer.

Prestige says that it plans to file regulatory applications for the biosimilar bevacizumab in the European Union and in the United States in 2020, and that it will present data from the SAMSON program during the upcoming European Society for Medical Oncology 2019 meeting in Barcelona, Spain.