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A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab

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Title: A randomised trial comparing the pharmacokinetics and safety of the biosimilar CT-P6 with reference trastuzumab
Authors: Esteva, FJ
Stebbing, J
Wood-Horrall, RN
Winkle, PJ
Lee, SY
Lee, SJ
Item Type: Journal Article
Abstract: PURPOSE: Access to trastuzumab, a valuable anti-cancer treatment, can be limited by cost. The primary aim of this study was to evaluate and compare the PK profiles of CT-P6, a biosimilar of trastuzumab, and US-licensed reference trastuzumab (Herceptin®) in healthy subjects. Secondary study aims included comparison of the safety and immunogenicity of CT-P6 and reference trastuzumab in these subjects. METHODS: We performed a single-dose, randomised, double-blind, parallel group study (NCT02665637) comparing CT-P6 with reference trastuzumab (6 mg/kg, 90 min intravenous infusion) in 70 healthy adult males. Pharmacokinetics, safety and immunogenicity were evaluated up to 10 weeks post-dose. Primary endpoints were area under the serum concentration-time curve (AUC) from time 0 to infinity (AUCinf); AUC from time 0 to last quantifiable concentration (AUClast); and observed maximum serum concentration (Cmax). The pre-determined equivalence criterion was a 90% confidence interval of 80-125% for ratios of geometric least squares (LS) means. RESULTS: Equivalence of CT-P6 and reference trastuzumab was demonstrated. Ratios (CT-P6/reference trastuzumab) of geometric LS means (90% confidence interval) were: AUCinf 99.05 (93.00, 105.51); AUClast 99.30 (92.85, 106.20); Cmax 96.58 (90.93, 102.59). Safety profiles were similar; treatment-emergent adverse events occurred in ten subjects (28.6%) in the CT-P6 group and 11 (31.4%) in the reference trastuzumab group. No serious adverse events or deaths occurred. No subjects tested positive for anti-drug antibodies. CONCLUSIONS: These data add to the totality of evidence required to demonstrate biosimilarity. A phase III study of CT-P6-in which equivalent neoadjuvant efficacy to reference trastuzumab has been demonstrated-is ongoing.
Issue Date: 12-Jan-2018
Date of Acceptance: 28-Dec-2017
URI: http://hdl.handle.net/10044/1/56390
DOI: https://dx.doi.org/10.1007/s00280-017-3510-7
ISSN: 0344-5704
Publisher: Springer Verlag
Start Page: 505
End Page: 514
Journal / Book Title: Cancer Chemotherapy and Pharmacology
Volume: 81
Issue: 3
Copyright Statement: © The Author(s) 2018. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
Sponsor/Funder: Imperial College Trust
Imperial College Trust
Medical Research Council (MRC)
National Institute for Health Research
Wellcome Trust
Action Against Cancer
Funder's Grant Number: n/a
WSCC_P35121
G1100425
NIHR-RP-011-053
097816/Z/11/B
082017-03
Keywords: Science & Technology
Life Sciences & Biomedicine
Oncology
Pharmacology & Pharmacy
Biosimilar
CT-P6
Equivalence
Pharmacokinetics
Safety
Trastuzumab
METASTATIC BREAST-CANCER
CLINICAL-PRACTICE GUIDELINES
PLUS ADJUVANT CHEMOTHERAPY
GASTRIC-CANCER
NEOADJUVANT CHEMOTHERAPY
1ST-LINE TREATMENT
AMERICAN SOCIETY
G5 COUNTRIES
FOLLOW-UP
PHASE-II
1115 Pharmacology And Pharmaceutical Sciences
Oncology & Carcinogenesis
Publication Status: Published
Appears in Collections:Division of Surgery
Division of Cancer
Faculty of Medicine



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