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 (AUC ); AUC from time 0 to last quantifiable concentration (AUC ); and observed inf last maximum serum concentration (C ). The pre-determined equivalence criterion was a 90% confidence interval of 80–125% max for ratios of geometric least squares (LS) means. Results Equivalence of CT-P6 and reference trastuzumab was demonstrated. Ratios (CT-P6/reference trastuzumab) of geo- metric LS means (90% confidence interval) were: AUC 99.05 (93.00, 105.51); AUC 99.30 (92.85, 106.20); C 96.58 inf last max (90.93, 102.59). Safety profiles were similar; treatment-emergent adverse events occurred in ten subjects (28.6%)
Cancer Chemotherapy and Pharmacology – Springer Journals
Published: Jan 12, 2018
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