Efficacy and safety of the proposed bevacizumab biosimilar BAT1706 compared with reference bevacizumab in patients with advanced nonsquamous non-small cell lung cancer: A randomized, double-blind, phase III study

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dc.authorwosidLiu, ZH/H-7536-2012
dc.contributor.authorChen, Likun
dc.contributor.authorRangel, Jose David Gomez
dc.contributor.authorCil, Timucin
dc.contributor.authorLi, Xingya
dc.contributor.authorCicin, Irfan
dc.contributor.authorShen, Yihong
dc.contributor.authorLiu, Zhihua
dc.date.accessioned2024-06-12T10:54:25Z
dc.date.available2024-06-12T10:54:25Z
dc.date.issued2023
dc.departmentTrakya Üniversitesien_US
dc.description.abstractBackground: BAT1706 is a proposed biosimilar of bevacizumab (Avastin (R)). We aimed to compare the efficacy and safety of BAT1706 with that of EU-sourced reference bevacizumab (EU-bevacizumab) in patients with advanced nonsquamous non-small cell lung cancer (NSCLC).Methods: Patients were randomized 1:1 to BAT1706 plus paclitaxel and carboplatin (BAT1706 arm) or EU-bevacizumab plus paclitaxel and carboplatin (EU-bevacizumab arm) given every 3 weeks for six cycles, followed by maintenance therapy with BAT1706 or EU-bevacizumab. The primary endpoint was overall response rate at week 18 (ORR18). Clinical equivalence was demonstrated if the 90% confidence interval (CI) of the BAT1706:EU-bevacizumab ORR18 risk ratio was contained within the predefined equivalence margins of 0.75-1.33 (China National Medical Products Administration requirements), or 0.73-1.36 (US Food and Drug Administration), or if the 95% CI of the ORR18 risk difference between treatments was contained within the predefined equivalence margin of -0.12 to 0.15 (EMA requirements).Results: In total, 649 randomized patients (BAT1706, n = 325; EU-bevacizumab, n = 324) received at least one cycle of combination treatment. The ORR18 was comparable between the BAT1706 and EU-bevacizumab arms (48.0% and 44.5%, respectively). The ORR(18 )risk ratio of 1.08 (90% CI: 0.94-1.24) and the ORR(18 )risk difference of 0.03 (95% CI: -0.04 to 0.11) were within the predefined equivalence margins, demonstrating the biosimilarity of BAT1706 and EU-bevacizumab. The safety profile of BAT1706 was consistent with that of EU-bevacizumab and no new safety signals were observed.Conclusion: In patients with advanced nonsquamous NSCLC, BAT1706 demonstrated clinical equivalence to EU-bevacizumab in terms of efficacy, safety, pharmacokinetics, and immunogenicity.en_US
dc.description.sponsorshipThe study was supported by Bio-Thera Solution Ltd. Employees of the sponsor had a role in study design, data analysis, and manuscript preparation. Employees of the funder had no role in data collection. Medical writing support was provided by Eve Blumson o; Bio-Thera Solution Ltd.; OPEN Health group; Sandoz/Hexal AGen_US
dc.description.sponsorshipThe study was supported by Bio-Thera Solution Ltd. Employees of the sponsor had a role in study design, data analysis, and manuscript preparation. Employees of the funder had no role in data collection. Medical writing support was provided by Eve Blumson of Spirit Medical Communications Ltd, part of the OPEN Health group, under the direction of Natalia Koptelova (MD, Sandoz) and was supported by Sandoz/Hexal AG.en_US
dc.identifier.doi10.1002/cam4.6664
dc.identifier.endpage20863en_US
dc.identifier.issn2045-7634
dc.identifier.issue22en_US
dc.identifier.pmid37935428en_US
dc.identifier.scopus2-s2.0-85176237773en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.startpage20847en_US
dc.identifier.urihttps://doi.org/10.1002/cam4.6664
dc.identifier.urihttps://hdl.handle.net/20.500.14551/19049
dc.identifier.volume12en_US
dc.identifier.wosWOS:001100074400001en_US
dc.identifier.wosqualityN/Aen_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherWileyen_US
dc.relation.ispartofCancer Medicineen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectBevacizumaben_US
dc.subjectBiosimilaren_US
dc.subjectEfficacyen_US
dc.subjectNonsquamous Non-Small Cell Lung Canceren_US
dc.subjectSafetyen_US
dc.subjectPlus Bevacizumaben_US
dc.subjectCarboplatinen_US
dc.subjectPaclitaxelen_US
dc.subjectConfidenceen_US
dc.subjectPharmacokineticsen_US
dc.subjectChemotherapyen_US
dc.subjectMulticenteren_US
dc.subjectPlaceboen_US
dc.subjectTrialen_US
dc.titleEfficacy and safety of the proposed bevacizumab biosimilar BAT1706 compared with reference bevacizumab in patients with advanced nonsquamous non-small cell lung cancer: A randomized, double-blind, phase III studyen_US
dc.typeArticleen_US

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