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Clin Ther. 2018 Mar;40(3):396-405.e4. doi: 10.1016/j.clinthera.2018.01.009. Epub 2018 Mar 2.

A Randomized Phase I Study Comparing the Pharmacokinetics of HD201, a Trastuzumab Biosimilar, With European Union-sourced Herceptin.

Author information

1
Paul Strauss Cancer Center, Strasbourg, France. Electronic address: xpivot@strasbourg.unicancer.fr.
2
Prestige BioPharma Pte Ltd, Singapore.

Abstract

PURPOSE:

This first-in-human study of HD201 was designed to evaluate the pharmacokinetic (PK) equivalence between this biosimilar candidate and trastuzumab sourced in the European Union (EU-trastuzumab)*.

METHODS:

In this randomized, blinded, single-dose comparative PK study, healthy male subjects were randomized to receive a single 6 mg/kg IV dose of HD201 or EU-trastuzumab. The primary PK end point was AUC0-∞. Equivalence was determined by using the predefined margins of 0.8 to 1.25. Other PK parameters were included as secondary end points.

FINDINGS:

Baseline demographic characteristics for the 73 randomized subjects were similar across the 2 groups: median age 29 and 30 years old (ranges 19 - 45), median weight 78.6 and 81.7 kg (ranges 60.2 - 101). The 90% CIs for the geometric least squares mean of the AUC0-∞ were included within the margins of 0.8 to 1.25. All other PK parameters were comparable for both HD201 and EU-trastuzumab. The proportions of subjects who experienced adverse events related to the study drug were 61.8% and 82.9% in the HD201 and EU-trastuzumab groups, respectively. The most frequently reported adverse events related to the study drug were infusion-related reactions. No subjects had positive results for antidrug antibodies after a single dose.

IMPLICATIONS:

This study reported the PK equivalence between HD201 and EU-trastuzumab. HD201 was well tolerated with no safety concerns after single-dose administration in healthy male subjects. EudraCT No.: 2012-000805-56.

KEYWORDS:

Herceptin; biosimilars; breast cancer; pharmacokinetics; trastuzumab

PMID:
29502805
DOI:
10.1016/j.clinthera.2018.01.009
[Indexed for MEDLINE]

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