Abstract CT063: BAT1706 demonstrates high similarity to Bevacizumab in comparative analysis with originator and phase I clinical trials in New Zealand and China

Abstract

Abstract Bevacizumab, a humanized monoclonal antibody against VEGF, has been approved by FDA to treat colon, lung, renal cancers and glioblastoma. We have developed BAT1706 as a biosimilar to Bevacizumab. Their evaluation was performed using several analytical assays and stress degradation studies. Both products BAT1706 shows similar binding affinity and biological function as Bevacizumab. In additionAdditionally, , several analytical assays and stress degradation studies have been conducted to compare multiple lots of BAT1706 and Bevacizumab. Tthe data indicate that BAT1706 is at least as pure as Bevacizumab and that the following attributes are consistent highly similar between both products: isoelectric point, peptide mapping profile, amino acid sequence, disulfide bond numbers and location, molecular weight and size, binding affinity towards the antigen and relevant immunologic receptors, isoform ratios, levels of impurities, glycosylation parameters, and secondary and tertiary structures. The degradation pathways and rates were evaluated using two different conditions (high temperature and strong light exposure) by means of several stability indicating methods. All Both products showed similar reactions during the incubating conditions and similar degradation rates. These data demonstrated that BAT1706 is highly similar to Bevacizumab, in structure, function, process impurities, and stability attributes. We have also completed two phase I studies with BAT1706 in New Zealand and China. Data revealed that a single IV infusion of BAT1706 (1 mg/kg) is safe and well tolerated in healthy subjects. No death was reported during either study and there was only 1 SAE of fibula fracture, which was not considered as related to BAT1706 by the investigator. The key PK parameters of both Phase I studies also revealed that BAT1706 is a bioequivalent to Bevacizumab. No positive results of anti-drug antibodiesy werewas reported for any subject in either study. Currently, a global randomized, double blind phase III study is on-going, to compare the efficacy, and to evaluate the safety and immunogenicity of BAT1706 to EU Bevacizumab in patients with previously untreated advanced non-squamous NSCLC. Citation Format: Jin-Chen Yu. BAT1706 demonstrates high similarity to Bevacizumab in comparative analysis with originator and phase I clinical trials in New Zealand and China [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr CT063.