Repositorio
Institucional

Kwak, Larry W.

Ogura, Michinori#Sancho, Juan Manuel#Cho, Seok-Goo#Nakazawa, Hideyuki#Suzumiya, Junji#Tumyan, Gayane#Kim, Jin Seok#Lennard, Anne#Mariz, Jose#Ilyin, Nikolai#Jurczak, Wojciech#Martinez, Aurelio Lopez#Samoilova, Olga#Zhavrid, Edvard#Ruiz, Eduardo Yanez#Trneny, Marek#Popplewell, Leslie#Coiffier, Bertrand#Buske, Christian#Kim, Woo-Seog#Lee, Sang Joon#Lee, Sung Young#Bae, Yun Ju

Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial

ELSEVIER SCI LTD

LANCET HAEMATOLOGY

en

Background Studies in patients with rheumatoid arthritis and advanced follicular lymphoma have shown that CT-P10, a rituximab biosimilar, has equivalent or non-inferior efficacy and pharmacokinetics to rituximab. We aimed to assess the therapeutic equivalence of single-agent CT-P10 and rituximab in patients with newly diagnosed low-tumour burden follicular lytnpliorna. Methods In this ongoing, randomised, double-blind, parallel-group, active-controlled, phase 3 trial, adult patients W.8 years) with stage II-IV low-tumour-burden follicular lymphoma were randomly assigned (1:1) using an interactive web or voice response system stratified by region, stage, and age to CT-P10 or US-sourced rituximab. Patients received CT-P10 or rituximab (375 mg/m(2) intravenous) on day 1 of four 7-day cycles (induction period). Patients who had disease control after the induction period continued to a maintenance period of CT-P10 or rituximab administered every 8 weeks for six cycles and, if completed, a second year of maintenance therapy of additional CT-P10 (every 8 weeks for six cycles) was offered. The study was partially unmasked after database lock (Feb 23, 2018) for all data up to 7 months (before cycle 3 of the maintenance period). The primary endpoint was the proportion of patients who achieved an overall response by 7 months in the intention-to-treat population. Efficacy equivalence was shown if the two-sided 90% CIs for the treatment difference in the proportion of responders between CT-P10 and rituximab was within the equivalence margin of 17%. This trial is registered with ClinicalTrials.gov, number NCT02260804. Findings Between Nov 9, 2015, and Jan 4, 2018, 402 patients were assessed for eligibility, of whom 258 were randomly assigned: 130 to CT-P10 and 128 to rituximab. 108 (83%) of 130 patients assigned to CT-P10 and 104 (81%) of 128 assigned to rituximab achieved an overall response by month 7 (treatment difference estimate 1-8%, 90% CI 6-43 to 10 20). Therapeutic equivalence was shown (90% CIs were within the prespecified margin of 17%). The most common grade 3 or 4 treatment-emergent adverse events were decreased neutrophil count (two grade 3 in the CT-P10 group) and neutropenia (one in each group), all other grade 3 or 4 treatment-emergent adverse events occurred in one patient each. Six (5%) of 130 patients who received CT-P10 and three (2%) of 128 who received rituximab experienced at least one treatment-emergent serious adverse event. Interpretation CT-P10 was equivalent to rituximab in terms of efficacy and was well tolerated. CT-P10 monotherapy is suggested as a new therapeutic option for patients with low-tumour-burden follicular lymphoma. Copyright (C) 2018 Elsevier Ltd. All rights reserved.

Artículo original

Celltrion, Inc.

10.1016/S2352-3026(18)30157-1

pdf

http://dx.doi.org/10.1016/S2352-3026(18)30157-1

Hematology

Farmacología y Farmacia

Biotecnología Relacionada con la Salud

Oncología

WOS:000448842300014

Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial

Artículo original

version publicada

ELSEVIER SCI LTD

LANCET HAEMATOLOGY

Hematología

2352-3026

en

Celltrion, Inc.

Celltrion, Inc.

pdf

suscripción

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