Cited 51 times in
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
DC Field | Value | Language |
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dc.contributor.author | 김진석 | - |
dc.date.accessioned | 2022-08-16T01:34:37Z | - |
dc.date.available | 2022-08-16T01:34:37Z | - |
dc.date.issued | 2018-11 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/188956 | - |
dc.description.abstract | 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 lymphoma. Methods: In this ongoing, randomised, double-blind, parallel-group, active-controlled, phase 3 trial, adult patients (≥18 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/m2 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. Funding: Celltrion, Inc. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Elsevier Ltd. | - |
dc.relation.isPartOf | LANCET HAEMATOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antibodies, Monoclonal, Murine-Derived / adverse effects | - |
dc.subject.MESH | Antibodies, Monoclonal, Murine-Derived / pharmacokinetics* | - |
dc.subject.MESH | Antibodies, Monoclonal, Murine-Derived / pharmacology | - |
dc.subject.MESH | Antibodies, Monoclonal, Murine-Derived / therapeutic use* | - |
dc.subject.MESH | Biosimilar Pharmaceuticals / adverse effects | - |
dc.subject.MESH | Biosimilar Pharmaceuticals / pharmacokinetics | - |
dc.subject.MESH | Biosimilar Pharmaceuticals / pharmacology | - |
dc.subject.MESH | Biosimilar Pharmaceuticals / therapeutic use | - |
dc.subject.MESH | Disease-Free Survival | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Lymphoma, Follicular / drug therapy* | - |
dc.subject.MESH | Lymphoma, Follicular / metabolism | - |
dc.subject.MESH | Lymphoma, Follicular / pathology* | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Rituximab / adverse effects | - |
dc.subject.MESH | Rituximab / pharmacokinetics | - |
dc.subject.MESH | Rituximab / pharmacology | - |
dc.subject.MESH | Rituximab / therapeutic use* | - |
dc.subject.MESH | Safety* | - |
dc.subject.MESH | Treatment Outcome | - |
dc.subject.MESH | Tumor Burden* / drug effects | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Michinori Ogura | - |
dc.contributor.googleauthor | Juan Manuel Sancho | - |
dc.contributor.googleauthor | Seok-Goo Cho | - |
dc.contributor.googleauthor | Hideyuki Nakazawa | - |
dc.contributor.googleauthor | Junji Suzumiya | - |
dc.contributor.googleauthor | Gayane Tumyan | - |
dc.contributor.googleauthor | Jin Seok Kim | - |
dc.contributor.googleauthor | Anne Lennard | - |
dc.contributor.googleauthor | José Mariz | - |
dc.contributor.googleauthor | Nikolai Ilyin | - |
dc.contributor.googleauthor | Wojciech Jurczak | - |
dc.contributor.googleauthor | Aurelio Lopez Martinez | - |
dc.contributor.googleauthor | Olga Samoilova | - |
dc.contributor.googleauthor | Edvard Zhavrid | - |
dc.contributor.googleauthor | Eduardo Yañez Ruiz | - |
dc.contributor.googleauthor | Marek Trneny | - |
dc.contributor.googleauthor | Leslie Popplewell | - |
dc.contributor.googleauthor | Bertrand Coiffier | - |
dc.contributor.googleauthor | Christian Buske | - |
dc.contributor.googleauthor | Won-Seog Kim | - |
dc.contributor.googleauthor | Sang Joon Lee | - |
dc.contributor.googleauthor | Sung Young Lee | - |
dc.contributor.googleauthor | Yun Ju Bae | - |
dc.contributor.googleauthor | Larry W Kwak | - |
dc.identifier.doi | 10.1016/S2352-3026(18)30157-1 | - |
dc.contributor.localId | A01017 | - |
dc.relation.journalcode | J03536 | - |
dc.identifier.eissn | 2352-3026 | - |
dc.identifier.pmid | 30389036 | - |
dc.identifier.url | https://www.clinicalkey.com/#!/content/playContent/1-s2.0-S2352302618301571 | - |
dc.contributor.alternativeName | Kim, Jin Seok | - |
dc.contributor.affiliatedAuthor | 김진석 | - |
dc.citation.volume | 5 | - |
dc.citation.number | 11 | - |
dc.citation.startPage | E543 | - |
dc.citation.endPage | E553 | - |
dc.identifier.bibliographicCitation | LANCET HAEMATOLOGY, Vol.5(11) : E543-E553, 2018-11 | - |
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