Efficacy and safety of two pegfilgrastim biosimilars: Tripegfilgrastim and pegteograstim

Our aim was to compare the efficacy and safety of two recently developed biosimilars of pegfilgrastim, a pegylated form of the recombinant human granulocyte‐colony stimulating factor (G‐CSF) analog filgrastim with those of the reference pegfilgrastim. We retrospectively analyzed data from patients d...

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Published in:Cancer medicine (Malden, MA) MA), 2020-09, Vol.9 (17), p.6102-6110
Main Authors: Kang, Ka‐Won, Lee, Byung‐Hyun, Jeon, Min Ji, Yu, Eun Sang, Kim, Dae Sik, Lee, Se Ryeon, Sung, Hwa Jung, Choi, Chul Won, Park, Yong, Kim, Byung Soo
Format: Article
Language:English
Subjects:
Biological products
biosimilar
Bone marrow
Chemotherapy
Clinical Cancer Research
Colony-stimulating factor
Drug dosages
febrile neutropenia
Granulocytes
Leukocytes (granulocytic)
Lymphoma
Neutropenia
Neutrophils
Original Research
Patients
pegylated granulocyte‐colony stimulating agent
Prophylaxis
Safety
Survival analysis
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creator Kang, Ka‐Won
Lee, Byung‐Hyun
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Park, Yong
Kim, Byung Soo
description Our aim was to compare the efficacy and safety of two recently developed biosimilars of pegfilgrastim, a pegylated form of the recombinant human granulocyte‐colony stimulating factor (G‐CSF) analog filgrastim with those of the reference pegfilgrastim. We retrospectively analyzed data from patients diagnosed with diffuse large B‐cell lymphoma (DLBCL) who were treated with first‐line R‐CHOP chemotherapy and received pegylated G‐CSF for primary prophylaxis. The following pegylated G‐CSFs were analyzed in this study: reference pegfilgrastim (Neulasta®) and two of its biosimilars (tripegfilgrastim; Dulastin® and pegteograstim; Neulapeg®). In total, 296 patients were enrolled. The number of patients with at least one episode of neutropenia during R‐CHOP chemotherapy was the lowest in the reference cohort (pegfilgrastim: 127 of 193 patients, 65.8%; tripegfilgrastim: 64 of 69 patients, 92.8%; pegteograstim: 28 of 34 patients, 82.4%, P 
doi_str_mv 10.1002/cam4.3261
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We retrospectively analyzed data from patients diagnosed with diffuse large B‐cell lymphoma (DLBCL) who were treated with first‐line R‐CHOP chemotherapy and received pegylated G‐CSF for primary prophylaxis. The following pegylated G‐CSFs were analyzed in this study: reference pegfilgrastim (Neulasta®) and two of its biosimilars (tripegfilgrastim; Dulastin® and pegteograstim; Neulapeg®). In total, 296 patients were enrolled. The number of patients with at least one episode of neutropenia during R‐CHOP chemotherapy was the lowest in the reference cohort (pegfilgrastim: 127 of 193 patients, 65.8%; tripegfilgrastim: 64 of 69 patients, 92.8%; pegteograstim: 28 of 34 patients, 82.4%, P &lt; .001). The number of patients with at least one episode of febrile neutropenia was also lowest in the reference cohort (pegfilgrastim: 67 of 193 patients, 34.7%; tripegfilgrastim: 38 of 69 patients, 55.1%; pegteograstim: 16 of 34 patients, 47.1%, P = .009). There were no differences in the duration of neutropenia and febrile neutropenia or treatment outcomes (rate of complete response or relapse and survival). There were no reports of grade 3 or higher adverse events requiring discontinuation of prophylactic pegylated G‐CSF in any group. The safety of the pegfilgrastim biosimilars for prophylactic purposes was comparable to that of the reference pegfilgrastim; however, in terms of their efficacy, the incidence of neutropenia and febrile neutropenia tended to be higher than that when using pegfilgrastim. The clinical relevance of these results in the biosimilar cohorts should be explored. The safety of the pegfilgrastim biosimilars for prophylactic purposes was comparable to that of the reference pegfilgrastim; however, in terms of their efficacy, the incidence of neutropenia and febrile neutropenia tended to be higher than that when using pegfilgrastim. The clinical relevance of these results in the biosimilar cohorts should be explored.</description><identifier>ISSN: 2045-7634</identifier><identifier>EISSN: 2045-7634</identifier><identifier>DOI: 10.1002/cam4.3261</identifier><identifier>PMID: 32633471</identifier><language>eng</language><publisher>United States: John Wiley &amp; Sons, Inc</publisher><subject>Biological products ; biosimilar ; Bone marrow ; Chemotherapy ; Clinical Cancer Research ; Colony-stimulating factor ; Drug dosages ; febrile neutropenia ; Granulocytes ; Leukocytes (granulocytic) ; Lymphoma ; Neutropenia ; Neutrophils ; Original Research ; Patients ; pegylated granulocyte‐colony stimulating agent ; Prophylaxis ; Safety ; Survival analysis</subject><ispartof>Cancer medicine (Malden, MA), 2020-09, Vol.9 (17), p.6102-6110</ispartof><rights>2020 The Authors. published by John Wiley &amp; Sons Ltd.</rights><rights>2020 The Authors. Cancer Medicine published by John Wiley &amp; Sons Ltd.</rights><rights>2020. 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We retrospectively analyzed data from patients diagnosed with diffuse large B‐cell lymphoma (DLBCL) who were treated with first‐line R‐CHOP chemotherapy and received pegylated G‐CSF for primary prophylaxis. The following pegylated G‐CSFs were analyzed in this study: reference pegfilgrastim (Neulasta®) and two of its biosimilars (tripegfilgrastim; Dulastin® and pegteograstim; Neulapeg®). In total, 296 patients were enrolled. The number of patients with at least one episode of neutropenia during R‐CHOP chemotherapy was the lowest in the reference cohort (pegfilgrastim: 127 of 193 patients, 65.8%; tripegfilgrastim: 64 of 69 patients, 92.8%; pegteograstim: 28 of 34 patients, 82.4%, P &lt; .001). The number of patients with at least one episode of febrile neutropenia was also lowest in the reference cohort (pegfilgrastim: 67 of 193 patients, 34.7%; tripegfilgrastim: 38 of 69 patients, 55.1%; pegteograstim: 16 of 34 patients, 47.1%, P = .009). There were no differences in the duration of neutropenia and febrile neutropenia or treatment outcomes (rate of complete response or relapse and survival). There were no reports of grade 3 or higher adverse events requiring discontinuation of prophylactic pegylated G‐CSF in any group. The safety of the pegfilgrastim biosimilars for prophylactic purposes was comparable to that of the reference pegfilgrastim; however, in terms of their efficacy, the incidence of neutropenia and febrile neutropenia tended to be higher than that when using pegfilgrastim. The clinical relevance of these results in the biosimilar cohorts should be explored. The safety of the pegfilgrastim biosimilars for prophylactic purposes was comparable to that of the reference pegfilgrastim; however, in terms of their efficacy, the incidence of neutropenia and febrile neutropenia tended to be higher than that when using pegfilgrastim. 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subjects Biological products
biosimilar
Bone marrow
Chemotherapy
Clinical Cancer Research
Colony-stimulating factor
Drug dosages
febrile neutropenia
Granulocytes
Leukocytes (granulocytic)
Lymphoma
Neutropenia
Neutrophils
Original Research
Patients
pegylated granulocyte‐colony stimulating agent
Prophylaxis
Safety
Survival analysis
title Efficacy and safety of two pegfilgrastim biosimilars: Tripegfilgrastim and pegteograstim
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