Academic Journal
A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab
| Τίτλος: | A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab |
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| Συγγραφείς: | Matthew Hummel, Tjerk Bosje, Andrew Shaw, Mark Shiyao Liu, Abhijit Barve, Mudgal Kothekar, Mark A. Socinski, Cornelius F. Waller |
| Πηγή: | J Cancer Res Clin Oncol |
| Στοιχεία εκδότη: | Springer Science and Business Media LLC, 2021. |
| Έτος έκδοσης: | 2021 |
| Θεματικοί όροι: | Adult, Male, 0301 basic medicine, Adolescent, Drug Compounding, Original Article – Clinical Oncology, Middle Aged, Healthy Volunteers, United States, 3. Good health, Adolescent [MeSH], Double-Blind Method [MeSH], Europe [MeSH], Therapeutic Equivalency [MeSH], Cancer, United States [MeSH], Adult [MeSH], 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], Bevacizumab, Europe, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Therapeutic Equivalency, Humans, Biosimilar Pharmaceuticals, Netherlands |
| Περιγραφή: | 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 (AUC0–∞). Pharmacokinetic parameters were analyzed using general linear models of analysis of variance. Secondary endpoints included safety and tolerability. 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 AUC0–∞ were close to 1, and 90% CIs were within the equivalence range (0.80–1.25). Secondary pharmacokinetic parameters (AUC from 0 to time of last quantifiable concentration [AUC0–t], peak serum concentration [Cmax], time to Cmax, elimination rate constant, and elimination half-life) were also comparable, with 90% CIs for ratios of AUC0–t and Cmax within 80–125%. Treatment-emergent adverse events were similar across all three treatment groups and were consistent with clinical data for bevacizumab. 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). |
| Τύπος εγγράφου: | Article Other literature type |
| Περιγραφή αρχείου: | |
| Γλώσσα: | English |
| ISSN: | 1432-1335 0171-5216 |
| DOI: | 10.1007/s00432-021-03628-0 |
| Σύνδεσμος πρόσβασης: | https://link.springer.com/content/pdf/10.1007/s00432-021-03628-0.pdf https://pubmed.ncbi.nlm.nih.gov/33866430 https://link.springer.com/content/pdf/10.1007/s00432-021-03628-0.pdf https://pubmed.ncbi.nlm.nih.gov/33866430/ https://link.springer.com/article/10.1007/s00432-021-03628-0 https://europepmc.org/article/MED/33866430 https://www.ncbi.nlm.nih.gov/pubmed/33866430 https://repository.publisso.de/resource/frl:6449880 |
| Rights: | CC BY URL: http://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (http://creativecommons.org/licenses/by/4.0/) . |
| Αριθμός Καταχώρησης: | edsair.doi.dedup.....4a570d77c895c19e606b9b22a00aebf4 |
| Βάση Δεδομένων: | OpenAIRE |
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