Proposed Bevacizumab Biosimilar BAT1706 Found Equivalent to Reference Bevacizumab for Advanced Nonsquamous Non-Small Cell Lung Cancer

According to a phase 3 trial, the proposed bevacizumab biosimilar BAT1706 demonstrated equivalence in terms of efficacy, safety, pharmacokinetics, and immunogenicity to the reference bevacizumab among patients with advanced nonsquamous non-small cell lung cancer (NSCLC).

Li-kun Chen, MD, Sun Yat-Sen University Cancer Center, Guangdong, Guangzhou, China, and coauthors explained, “BAT1706 is a recombinant humanized anti-VEGF monoclonal antibody developed…as a proposed biosimilar of bevacizumab to meet the need for alternatives to expensive biologic agents.” In phase 1 studies, a single intravenous infusion of the biosimilar was found to be well-tolerated among healthy participants.

This trial enrolled 649 patients with stage IV nonsquamous NSCLC or recurrent disease without EGFR or ALK mutations, who had not received prior systemic therapy for metastatic disease. Patients were randomized on a 1-to-1 basis to receive either BAT1706 plus paclitaxel and carboplatin (n = 325) or the EU-sourced bevacizumab plus paclitaxel and carboplatin (n = 324). The regimen was administered every 3 weeks for 6 cycles, followed by maintenance therapy of either BAT1706 or reference bevacizumab. The primary end point was overall response rate (ORR) at week 18.

At the time of data-cutoff, the median treatment duration was 29.1 weeks in the BAT1706 arm and 27.0 weeks in the reference bevacizumab arm. The ORR at week 18 was comparable between the BAT1706 arm (48.0%) and the reference bevacizumab arm (44.5%). The 18-week ORR risk ratio between the BAT1706 arm and the reference bevacizumab arm was 1.08 and the 18-week ORR risk difference was 0.03, which were both within the predefined equivalence margins. The safety profile of BAT1706 was consistent with that of reference bevacizumab, with no new safety signals observed.

Dr Chen et al concluded, “Based upon equivalence margin criteria for biosimilarity stipulated by three international regulatory agencies (FDA, NMPA, and EMA), this study demonstrated the biosimilarity of BAT1706 and EU-bevacizumab.”

Source:

Chen L, Gomez Rangel JD, Cil T, et al. Efficacy and safety of the proposed bevacizumab biosimilar BAT1706 compared with reference bevacizumab in patients with advanced nonsquamous non-small cell lung cancer: A randomized, double-blind, phase III study. Cancer Medicine. Published online November 7, 2023. doi:10.1002/cam4.6664