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

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 wi...

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Veröffentlicht in:The Lancet. Haematology 2018-11, Vol.5 (11), p.e543-e553
Hauptverfasser: Ogura, Michinori, Sancho, Juan Manuel, Cho, Seok-Goo, Nakazawa, Hideyuki, Suzumiya, Junji, Tumyan, Gayane, Kim, Jin Seok, Lennard, Anne, Mariz, José, Ilyin, Nikolai, Jurczak, Wojciech, Lopez Martinez, Aurelio, Samoilova, Olga, Zhavrid, Edvard, Yañez Ruiz, Eduardo, Trneny, Marek, Popplewell, Leslie, Coiffier, Bertrand, Buske, Christian, Kim, Won-Seog, Lee, Sang Joon, Lee, Sung Young, Bae, Yun Ju, Kwak, Larry W
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container_end_page e553
container_issue 11
container_start_page e543
container_title The Lancet. Haematology
container_volume 5
creator Ogura, Michinori
Sancho, Juan Manuel
Cho, Seok-Goo
Nakazawa, Hideyuki
Suzumiya, Junji
Tumyan, Gayane
Kim, Jin Seok
Lennard, Anne
Mariz, José
Ilyin, Nikolai
Jurczak, Wojciech
Lopez Martinez, Aurelio
Samoilova, Olga
Zhavrid, Edvard
Yañez Ruiz, Eduardo
Trneny, Marek
Popplewell, Leslie
Coiffier, Bertrand
Buske, Christian
Kim, Won-Seog
Lee, Sang Joon
Lee, Sung Young
Bae, Yun Ju
Kwak, Larry W
description 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. 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. 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. CT-P10 was equivalent to rituximab in terms of eff
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We aimed to assess the therapeutic equivalence of single-agent CT-P10 and rituximab in patients with newly diagnosed low-tumour burden follicular lymphoma. 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. 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. 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. Celltrion, Inc.</description><identifier>ISSN: 2352-3026</identifier><identifier>EISSN: 2352-3026</identifier><identifier>DOI: 10.1016/S2352-3026(18)30157-1</identifier><identifier>PMID: 30389036</identifier><language>eng</language><publisher>England: Elsevier Ltd</publisher><subject>Antibodies, Monoclonal, Murine-Derived - adverse effects ; Antibodies, Monoclonal, Murine-Derived - pharmacokinetics ; Antibodies, Monoclonal, Murine-Derived - pharmacology ; Antibodies, Monoclonal, Murine-Derived - therapeutic use ; Biosimilar Pharmaceuticals - adverse effects ; Biosimilar Pharmaceuticals - pharmacokinetics ; Biosimilar Pharmaceuticals - pharmacology ; Biosimilar Pharmaceuticals - therapeutic use ; Disease-Free Survival ; Double-Blind Method ; Female ; Humans ; Lymphoma, Follicular - drug therapy ; Lymphoma, Follicular - metabolism ; Lymphoma, Follicular - pathology ; Male ; Middle Aged ; Rituximab - adverse effects ; Rituximab - pharmacokinetics ; Rituximab - pharmacology ; Rituximab - therapeutic use ; Safety ; Treatment Outcome ; Tumor Burden - drug effects</subject><ispartof>The Lancet. Haematology, 2018-11, Vol.5 (11), p.e543-e553</ispartof><rights>2018 Elsevier Ltd</rights><rights>Copyright © 2018 Elsevier Ltd. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c365t-662af4d54aff5bcaa620031014302cf1d646787ae0031422056d51f70ba575713</citedby><cites>FETCH-LOGICAL-c365t-662af4d54aff5bcaa620031014302cf1d646787ae0031422056d51f70ba575713</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30389036$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ogura, Michinori</creatorcontrib><creatorcontrib>Sancho, Juan Manuel</creatorcontrib><creatorcontrib>Cho, Seok-Goo</creatorcontrib><creatorcontrib>Nakazawa, Hideyuki</creatorcontrib><creatorcontrib>Suzumiya, Junji</creatorcontrib><creatorcontrib>Tumyan, Gayane</creatorcontrib><creatorcontrib>Kim, Jin Seok</creatorcontrib><creatorcontrib>Lennard, Anne</creatorcontrib><creatorcontrib>Mariz, José</creatorcontrib><creatorcontrib>Ilyin, Nikolai</creatorcontrib><creatorcontrib>Jurczak, Wojciech</creatorcontrib><creatorcontrib>Lopez Martinez, Aurelio</creatorcontrib><creatorcontrib>Samoilova, Olga</creatorcontrib><creatorcontrib>Zhavrid, Edvard</creatorcontrib><creatorcontrib>Yañez Ruiz, Eduardo</creatorcontrib><creatorcontrib>Trneny, Marek</creatorcontrib><creatorcontrib>Popplewell, Leslie</creatorcontrib><creatorcontrib>Coiffier, Bertrand</creatorcontrib><creatorcontrib>Buske, Christian</creatorcontrib><creatorcontrib>Kim, Won-Seog</creatorcontrib><creatorcontrib>Lee, Sang Joon</creatorcontrib><creatorcontrib>Lee, Sung Young</creatorcontrib><creatorcontrib>Bae, Yun Ju</creatorcontrib><creatorcontrib>Kwak, Larry W</creatorcontrib><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</title><title>The Lancet. Haematology</title><addtitle>Lancet Haematol</addtitle><description>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. 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. 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. 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. 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Sancho, Juan Manuel ; Cho, Seok-Goo ; Nakazawa, Hideyuki ; Suzumiya, Junji ; Tumyan, Gayane ; Kim, Jin Seok ; Lennard, Anne ; Mariz, José ; Ilyin, Nikolai ; Jurczak, Wojciech ; Lopez Martinez, Aurelio ; Samoilova, Olga ; Zhavrid, Edvard ; Yañez Ruiz, Eduardo ; Trneny, Marek ; Popplewell, Leslie ; Coiffier, Bertrand ; Buske, Christian ; Kim, Won-Seog ; Lee, Sang Joon ; Lee, Sung Young ; Bae, Yun Ju ; Kwak, Larry W</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c365t-662af4d54aff5bcaa620031014302cf1d646787ae0031422056d51f70ba575713</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Antibodies, Monoclonal, Murine-Derived - adverse effects</topic><topic>Antibodies, Monoclonal, Murine-Derived - pharmacokinetics</topic><topic>Antibodies, Monoclonal, Murine-Derived - pharmacology</topic><topic>Antibodies, Monoclonal, Murine-Derived - therapeutic use</topic><topic>Biosimilar Pharmaceuticals - adverse effects</topic><topic>Biosimilar Pharmaceuticals - pharmacokinetics</topic><topic>Biosimilar Pharmaceuticals - pharmacology</topic><topic>Biosimilar Pharmaceuticals - therapeutic use</topic><topic>Disease-Free Survival</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Humans</topic><topic>Lymphoma, Follicular - drug therapy</topic><topic>Lymphoma, Follicular - metabolism</topic><topic>Lymphoma, Follicular - pathology</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Rituximab - adverse effects</topic><topic>Rituximab - pharmacokinetics</topic><topic>Rituximab - pharmacology</topic><topic>Rituximab - therapeutic use</topic><topic>Safety</topic><topic>Treatment Outcome</topic><topic>Tumor Burden - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ogura, Michinori</creatorcontrib><creatorcontrib>Sancho, Juan Manuel</creatorcontrib><creatorcontrib>Cho, Seok-Goo</creatorcontrib><creatorcontrib>Nakazawa, Hideyuki</creatorcontrib><creatorcontrib>Suzumiya, Junji</creatorcontrib><creatorcontrib>Tumyan, Gayane</creatorcontrib><creatorcontrib>Kim, Jin Seok</creatorcontrib><creatorcontrib>Lennard, Anne</creatorcontrib><creatorcontrib>Mariz, José</creatorcontrib><creatorcontrib>Ilyin, Nikolai</creatorcontrib><creatorcontrib>Jurczak, Wojciech</creatorcontrib><creatorcontrib>Lopez Martinez, Aurelio</creatorcontrib><creatorcontrib>Samoilova, Olga</creatorcontrib><creatorcontrib>Zhavrid, Edvard</creatorcontrib><creatorcontrib>Yañez Ruiz, Eduardo</creatorcontrib><creatorcontrib>Trneny, Marek</creatorcontrib><creatorcontrib>Popplewell, Leslie</creatorcontrib><creatorcontrib>Coiffier, Bertrand</creatorcontrib><creatorcontrib>Buske, Christian</creatorcontrib><creatorcontrib>Kim, Won-Seog</creatorcontrib><creatorcontrib>Lee, Sang Joon</creatorcontrib><creatorcontrib>Lee, Sung Young</creatorcontrib><creatorcontrib>Bae, Yun Ju</creatorcontrib><creatorcontrib>Kwak, Larry W</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>The Lancet. 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Haematology</jtitle><addtitle>Lancet Haematol</addtitle><date>2018-11</date><risdate>2018</risdate><volume>5</volume><issue>11</issue><spage>e543</spage><epage>e553</epage><pages>e543-e553</pages><issn>2352-3026</issn><eissn>2352-3026</eissn><abstract>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. 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. 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. 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. Celltrion, Inc.</abstract><cop>England</cop><pub>Elsevier Ltd</pub><pmid>30389036</pmid><doi>10.1016/S2352-3026(18)30157-1</doi></addata></record>
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subjects Antibodies, Monoclonal, Murine-Derived - adverse effects
Antibodies, Monoclonal, Murine-Derived - pharmacokinetics
Antibodies, Monoclonal, Murine-Derived - pharmacology
Antibodies, Monoclonal, Murine-Derived - therapeutic use
Biosimilar Pharmaceuticals - adverse effects
Biosimilar Pharmaceuticals - pharmacokinetics
Biosimilar Pharmaceuticals - pharmacology
Biosimilar Pharmaceuticals - therapeutic use
Disease-Free Survival
Double-Blind Method
Female
Humans
Lymphoma, Follicular - drug therapy
Lymphoma, Follicular - metabolism
Lymphoma, Follicular - pathology
Male
Middle Aged
Rituximab - adverse effects
Rituximab - pharmacokinetics
Rituximab - pharmacology
Rituximab - therapeutic use
Safety
Treatment Outcome
Tumor Burden - drug effects
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
url https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-25T06%3A08%3A37IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Efficacy,%20pharmacokinetics,%20and%20safety%20of%20the%20biosimilar%20CT-P10%20in%20comparison%20with%20rituximab%20in%20patients%20with%20previously%20untreated%20low-tumour-burden%20follicular%20lymphoma:%20a%20randomised,%20double-blind,%20parallel-group,%20phase%203%20trial&rft.jtitle=The%20Lancet.%20Haematology&rft.au=Ogura,%20Michinori&rft.date=2018-11&rft.volume=5&rft.issue=11&rft.spage=e543&rft.epage=e553&rft.pages=e543-e553&rft.issn=2352-3026&rft.eissn=2352-3026&rft_id=info:doi/10.1016/S2352-3026(18)30157-1&rft_dat=%3Cproquest_cross%3E2129532817%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2129532817&rft_id=info:pmid/30389036&rft_els_id=S2352302618301571&rfr_iscdi=true