Repositorio
Institucional

Ohe, Yuichiro

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

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

ADIS INT LTD

BIODRUGS

en

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.

artículo original

10.1007/s40259-022-00552-8

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PHASE-III TRIAL

COST-EFFECTIVENESS

THERAPY

CHEMOTHERAPY

CARBOPLATIN

PACLITAXEL

EFFICACY

SAFETY

Oncología

Inmunología

Farmacología y farmacia

PRUEBA FASE III

RENTAJE

TERAPIA

QUIMIOTERAPIA

CARBOPLATINO

PACLITAXEL

EFICACIA

SEGURIDAD

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

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artículo original

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CC BY-NC 4.0

CC BY-NC 4.0

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WOS:000861173900001