A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab

Purpose!#!Bevacizumab is a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor-specific angiogenesis in some cancers. MYL-1402O is a proposed bevacizumab biosimilar.!##!Methods!#!The primary objective of this single-center, randomized, double-blind, three-arm, parallel-group, phase 1 study in healthy male volunteers was to evaluate bioequivalence of MYL-1402O to EU and US-reference bevacizumab, and EU-reference bevacizumab to US-reference bevacizumab. The primary pharmacokinetic parameter was area under the serum concentration-time curve from 0 extrapolat... Mehr ...

Verfasser: Hummel, Matthew
Bosje, Tjerk
Shaw, Andrew
Liu, Mark Shiyao
Barve, Abhijit
Kothekar, Mudgal
Socinski, Mark A.
Waller, Cornelius
Dokumenttyp: Zeitschriftenartikel
Erscheinungsdatum: 2021
Schlagwörter: Adolescent [MeSH] / Double-Blind Method [MeSH] / Europe [MeSH] / Therapeutic Equivalency [MeSH] / Cancer / United States [MeSH] / Adult [MeSH] / Original Article – Clinical Oncology / Biosimilar Pharmaceuticals/pharmacokinetics [MeSH] / Humans [MeSH] / Bevacizumab/pharmacokinetics [MeSH] / Monoclonal antibody / Middle Aged [MeSH] / Bevacizumab/chemistry [MeSH] / Male [MeSH] / Drug Compounding/standards [MeSH] / Pharmacokinetics / Healthy Volunteers [MeSH] / Young Adult [MeSH] / Phase 1 / Drug Compounding/methods [MeSH] / Netherlands [MeSH] / Bioequivalence / Biosimilar Pharmaceuticals/chemistry [MeSH]
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-26846490
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://repository.publisso.de/resource/frl:6449880

Purpose!#!Bevacizumab is a recombinant humanized monoclonal antibody that inhibits vascular endothelial growth factor-specific angiogenesis in some cancers. MYL-1402O is a proposed bevacizumab biosimilar.!##!Methods!#!The primary objective of this single-center, randomized, double-blind, three-arm, parallel-group, phase 1 study in healthy male volunteers was to evaluate bioequivalence of MYL-1402O to EU and US-reference bevacizumab, and EU-reference bevacizumab to US-reference bevacizumab. The primary pharmacokinetic parameter was area under the serum concentration-time curve from 0 extrapolated to infinity (AUC!##!Results!#!Of 111 enrolled subjects, 110 were included in the pharmacokinetic analysis (MYL-1402O, n = 37; EU-reference bevacizumab, n = 36; US-reference bevacizumab, n = 37). Bioequivalence was demonstrated between MYL-1402O and EU-reference bevacizumab, MYL-1402O and US-reference bevacizumab, and between EU- and US-reference bevacizumab where least squares mean ratios of AUC!##!Conclusion!#!MYL-1402O was well tolerated and demonstrated pharmacokinetic and safety profiles similar to EU-reference bevacizumab and US-reference bevacizumab in healthy male volunteers. No new significant safety issues emerged (ClinicalTrials.gov, NCT02469987; ClinicalTrialsRegister.eu EudraCT, 2014-005621-12; June 12, 2015).