演題抄録

一般演題 (示説)

開催概要
開催回
第54回・2016年・横浜
 

Pharmacokinetic similarity of ABP 980 relative to trastuzumab in the Japanese subset: Results from a randomized, single-blind, single-dose, parallel group study in healthy subjects

演題番号 : P25-1

[筆頭演者]
Hanes Vladimir:1 
[共同演者]
Chow Vincent:1、Zhang Nan:1、Markus Richard:1

1:Amgen, USA・Biosimilars

 

Background: ABP 980 is being developed as a biosimilar to trastuzumab, a monoclonal antibody that binds human epidermal growth factor receptor 2, resulting in proliferation inhibition and induction of antibody-dependent cell-mediated cytotoxicity. Preclinical assessments have shown that ABP 980 is analytically and functionally similar to trastuzumab. Results from this phase 1 study demonstrated pharmacokinetic (PK) similarity between ABP 980 and trastuzumab; CIs for geometric mean (GM) ratios for maximum observed serum concentration (Cmax) and area under the serum concentration-time curve from time 0 to infinity (AUCinf) fell within the standard prespecified bioequivalence criteria of 0.80-1.25.
Objectives: This phase 1 study included a subgroup of Japanese subjects; here we show results for this subset.
Methods: PK similarity was evaluated in a randomized, single-blind, single-dose, parallel-group study in healthy adult men comparing ABP 980 with FDA-licensed and EU-authorized trastuzumab. Primary endpoints were Cmax and AUCinf; secondary endpoints included safety and immunogenicity.
Results: Baseline characteristics were similar among the 3 groups. PK similarity was demonstrated for the comparison of ABP 980 with trastuzumab in the Japanese subset. After a single 6 mg/kg intravenous infusion, the GM of Cmax and AUCinf were 124.99 µg/mL and 30245.7µg·h/mL for ABP 980; 131.59µg/mL and 31184.1 µg·h/mL for FDA-licensed trastuzumab and 130.92 µg/mL and 33605.4 µg·h/mL for EU-authorized trastuzumab. These results were consistent with the overall results for the entire PK population. The incidence of treatment-emergent adverse events in this population was comparable among treatment groups (ABP 980=70%; FDA-licensed trastuzumab=80%; EU-authorized trastuzumab=73%). No anti-drug antibodies were detected.
Conclusions: ABP 980 has been shown to have similar PK compared with trastuzumab in this phase 1 study; this result is consistent in a subset of Japanese subjects.

キーワード

臓器別:胃・十二指腸

手法別:臨床試験

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