Repositorio UFRO · Omeka S

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

Primer Autor	Ohe, Yuichiro
Co-autores	Verschraegen, Claire Andric, Zoran Moiseenko, Fedor Makharadze, Tamta Shevnya, Sergii Oleksiienko, Alona Ruiz, Eduardo Yanez Kim, SungHyun Ahn, KeumYoung Park, TaeHong Park, Sijin Ju, Hana
Título	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
Editorial	ADIS INT LTD
Revista	BIODRUGS
Lenguaje	en
Resumen	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.
Tipo de Recurso	artículo original
doi	10.1007/s40259-022-00552-8
Formato Recurso	PDF
Palabras Claves	PHASE-III TRIAL COST-EFFECTIVENESS THERAPY CHEMOTHERAPY CARBOPLATIN PACLITAXEL EFFICACY SAFETY
Ubicación del archivo	http://dx.doi.org/10.1007/s40259-022-00552-8
Categoría OCDE	Oncología Inmunología Farmacología y farmacia
Materias	PRUEBA FASE III RENTAJE TERAPIA QUIMIOTERAPIA CARBOPLATINO PACLITAXEL EFICACIA SEGURIDAD
Disciplinas de la OCDE	Oncología Farmacología y Farmacia Biotecnología Relacionada con la Salud
Versión del recurso (Recomendado-único)	version publicada
Tipo de ruta	hibrida verde
Access Rights	acceso abierto
Derechos de acceso	acceso abierto
Id de Web of Science	WOS:000861173900001
Título de la cita (Recomendado-único)	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
Página de inicio (Recomendado-único)	749
Página final (Recomendado-único)	760
Identificador del recurso (Mandatado-único)	artículo original
License	CC BY-NC 4.0
Condición de la licencia (Recomendado-repetible)	CC BY-NC 4.0