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A phase I, randomized, single-dose pharmacokinetic study comparing sb8 (bevacizumab biosimilar) with reference

Donghoon Shin¹, Yoon Jung Lee², Jihye Choi³

¹Medical Affairs, Samsung Bioepis Co., Ltd, Incheon, Korea. dh01.shin@samsung.com.

Cancer Chemotherapy and Pharmacology

|September 19, 2020

Purpose:

To compare pharmacokinetics, safety, tolerability, and immunogenicity between SB8, a bevacizumab biosimilar, and the European Union (EU) and United States (US) reference products (bevacizumab-EU, bevacizumab-US).

Methods:

In this randomized, double-blind, parallel-group, and single-dose study, healthy volunteers were randomized to receive a 3 mg/kg dose of SB8, bevacizumab-EU, or bevacizumab-US via intravenous infusion. Primary endpoints were area under the concentration-time curve from time zero to infinity (AUC_inf) and to the last quantifiable concentration (AUC_last), and maximum observed serum concentration (C_max). Bioequivalence was achieved if 90% confidence intervals (CIs) for the ratios of the geometric least squares means (LSMeans) of primary endpoints were within the predefined bioequivalence margins of 80.00-125.00%. Safety and immunogenicity were also investigated.

Results:

The 90% CIs for the geometric LSMean ratios of AUC_inf, AUC_last and C_max were all within the prespecified bioequivalence margins. Geometric LSMean ratios for SB8/bevacizumab-EU, SB8/bevacizumab-US and bevacizumab-EU/bevacizumab-US were 88.01%, 88.48% and 100.54% for AUC_inf, 88.65%, 89.08% and 100.49% for AUC_last and 99.59%, 101.15% and 101.56% for C_max, respectively. Incidence of treatment-emergent adverse events (TEAEs) across treatment groups was comparable (SB8: 50.0%, bevacizumab-EU: 37.5%, bevacizumab-US: 53.8%). Most TEAEs were mild and considered as not related to the study drug. No deaths or treatment discontinuations due to adverse events occurred. Incidence of anti-drug antibodies was also comparable between all groups and no neutralizing antibodies were detected.

Conclusion:

This study demonstrated pharmacokinetic bioequivalence and similar safety and immunogenicity profiles of SB8 to both reference products, bevacizumab-EU and bevacizumab-US, and of bevacizumab-EU to bevacizumab-US. CLINICALTRIALS.

Gov Identifier:

NCT02453672 (submitted date); EudraCT number: 2015-001,026-41.

Keywords:

Bevacizumab Biosimilar Immunogenicity Pharmacokinetics SB8

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