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Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial

BACKGROUND: CT-P16 is a candidate bevacizumab biosimilar. OBJECTIVE: This double-blind, multicenter, parallel-group, phase III study aimed to establish equivalent efficacy between CT-P16 and European Union-approved reference bevacizumab (EU-bevacizumab) in patients with metastatic or recurrent non-s...

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Autores principales: Verschraegen, Claire, Andric, Zoran, Moiseenko, Fedor, Makharadze, Tamta, Shevnya, Sergii, Oleksiienko, Alona, Yañez Ruiz, Eduardo, Kim, SungHyun, Ahn, KeumYoung, Park, TaeHong, Park, Sijin, Ju, Hana, Ohe, Yuichiro
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9649513/
https://www.ncbi.nlm.nih.gov/pubmed/36169807
http://dx.doi.org/10.1007/s40259-022-00552-8
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author Verschraegen, Claire
Andric, Zoran
Moiseenko, Fedor
Makharadze, Tamta
Shevnya, Sergii
Oleksiienko, Alona
Yañez Ruiz, Eduardo
Kim, SungHyun
Ahn, KeumYoung
Park, TaeHong
Park, Sijin
Ju, Hana
Ohe, Yuichiro
author_facet Verschraegen, Claire
Andric, Zoran
Moiseenko, Fedor
Makharadze, Tamta
Shevnya, Sergii
Oleksiienko, Alona
Yañez Ruiz, Eduardo
Kim, SungHyun
Ahn, KeumYoung
Park, TaeHong
Park, Sijin
Ju, Hana
Ohe, Yuichiro
author_sort Verschraegen, Claire
collection PubMed
description BACKGROUND: CT-P16 is a candidate bevacizumab biosimilar. OBJECTIVE: This double-blind, multicenter, parallel-group, phase III study aimed to establish equivalent efficacy between CT-P16 and European Union-approved reference bevacizumab (EU-bevacizumab) in patients with metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC). PATIENTS AND METHODS: Patients with stage IV or recurrent nsNSCLC were randomized (1:1) to receive CT-P16 or EU-bevacizumab (15 mg/kg every 3 weeks; ≤ 6 cycles) with paclitaxel (200 mg/m(2)) and carboplatin (area under the curve 6.0; both for 4–6 cycles), as induction therapy. Patients with controlled disease after induction therapy continued with CT-P16 or EU-bevacizumab maintenance therapy. The primary endpoint was objective response rate (ORR) during the induction period. Time-to-event analyses, pharmacokinetics, safety, and immunogenicity were also evaluated. Results obtained after 1 year of follow-up are presented. RESULTS: Overall, 689 patients were randomized (CT-P16, N = 342; EU-bevacizumab, N = 347). ORR was 42.40% (95% confidence interval [CI] 37.16–47.64) and 42.07% (95% CI 36.88–47.27) for CT-P16 and EU-bevacizumab, respectively. The risk difference (0.40 [95% CI − 7.02 to 7.83]) and risk ratio (1.0136 [90% CI 0.8767–1.1719]) for ORR fell within predefined equivalence margins (− 12.5 to + 12.5%, and 0.7368 to 1.3572, respectively), demonstrating equivalence between CT-P16 and EU-bevacizumab. Median response duration, time to progression, progression-free survival, and overall survival were comparable between treatment groups. Safety profiles were similar: 96.2% (CT-P16) and 93.0% (EU-bevacizumab) of patients experienced treatment-emergent adverse events. Pharmacokinetics and immunogenicity were comparable between groups. CONCLUSIONS: Equivalent efficacy and similar pharmacokinetics, safety, and immunogenicity support bioequivalence of CT-P16 and EU-bevacizumab in patients with nsNSCLC. TRIAL REGISTRATION NUMBER: NCT03676192. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40259-022-00552-8.
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spelling pubmed-96495132022-11-15 Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial Verschraegen, Claire Andric, Zoran Moiseenko, Fedor Makharadze, Tamta Shevnya, Sergii Oleksiienko, Alona Yañez Ruiz, Eduardo Kim, SungHyun Ahn, KeumYoung Park, TaeHong Park, Sijin Ju, Hana Ohe, Yuichiro BioDrugs Original Research Article BACKGROUND: CT-P16 is a candidate bevacizumab biosimilar. OBJECTIVE: This double-blind, multicenter, parallel-group, phase III study aimed to establish equivalent efficacy between CT-P16 and European Union-approved reference bevacizumab (EU-bevacizumab) in patients with metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC). PATIENTS AND METHODS: Patients with stage IV or recurrent nsNSCLC were randomized (1:1) to receive CT-P16 or EU-bevacizumab (15 mg/kg every 3 weeks; ≤ 6 cycles) with paclitaxel (200 mg/m(2)) and carboplatin (area under the curve 6.0; both for 4–6 cycles), as induction therapy. Patients with controlled disease after induction therapy continued with CT-P16 or EU-bevacizumab maintenance therapy. The primary endpoint was objective response rate (ORR) during the induction period. Time-to-event analyses, pharmacokinetics, safety, and immunogenicity were also evaluated. Results obtained after 1 year of follow-up are presented. RESULTS: Overall, 689 patients were randomized (CT-P16, N = 342; EU-bevacizumab, N = 347). ORR was 42.40% (95% confidence interval [CI] 37.16–47.64) and 42.07% (95% CI 36.88–47.27) for CT-P16 and EU-bevacizumab, respectively. The risk difference (0.40 [95% CI − 7.02 to 7.83]) and risk ratio (1.0136 [90% CI 0.8767–1.1719]) for ORR fell within predefined equivalence margins (− 12.5 to + 12.5%, and 0.7368 to 1.3572, respectively), demonstrating equivalence between CT-P16 and EU-bevacizumab. Median response duration, time to progression, progression-free survival, and overall survival were comparable between treatment groups. Safety profiles were similar: 96.2% (CT-P16) and 93.0% (EU-bevacizumab) of patients experienced treatment-emergent adverse events. Pharmacokinetics and immunogenicity were comparable between groups. CONCLUSIONS: Equivalent efficacy and similar pharmacokinetics, safety, and immunogenicity support bioequivalence of CT-P16 and EU-bevacizumab in patients with nsNSCLC. TRIAL REGISTRATION NUMBER: NCT03676192. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40259-022-00552-8. Springer International Publishing 2022-09-28 2022 /pmc/articles/PMC9649513/ /pubmed/36169807 http://dx.doi.org/10.1007/s40259-022-00552-8 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial 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-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research Article
Verschraegen, Claire
Andric, Zoran
Moiseenko, Fedor
Makharadze, Tamta
Shevnya, Sergii
Oleksiienko, Alona
Yañez Ruiz, Eduardo
Kim, SungHyun
Ahn, KeumYoung
Park, TaeHong
Park, Sijin
Ju, Hana
Ohe, Yuichiro
Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial
title Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial
title_full Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial
title_fullStr Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial
title_full_unstemmed Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial
title_short Candidate Bevacizumab Biosimilar CT-P16 versus European Union Reference Bevacizumab in Patients with Metastatic or Recurrent Non-Small Cell Lung Cancer: A Randomized Controlled Trial
title_sort candidate bevacizumab biosimilar ct-p16 versus european union reference bevacizumab in patients with metastatic or recurrent non-small cell lung cancer: a randomized controlled trial
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9649513/
https://www.ncbi.nlm.nih.gov/pubmed/36169807
http://dx.doi.org/10.1007/s40259-022-00552-8
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