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Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study

The phase 3 COLUMBA study demonstrated noninferiority of subcutaneous daratumumab (DARA SC) to intravenous daratumumab (DARA IV) in relapsed or refractory multiple myeloma. We present a subgroup analysis of Asian patients from COLUMBA. Eligible patients had ≥ 3 prior lines of therapy, including a pr...

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Autores principales: Iida, Shinsuke, Ishikawa, Takayuki, Min, Chang Ki, Kim, Kihyun, Yeh, Su Peng, Usmani, Saad Z., Mateos, Maria-Victoria, Nahi, Hareth, Heuck, Christoph, Qin, Xiang, Parasrampuria, Dolly A., Gries, Katharine S., Qi, Ming, Bahlis, Nizar, Ito, Shigeki
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7960612/
https://www.ncbi.nlm.nih.gov/pubmed/33599794
http://dx.doi.org/10.1007/s00277-021-04405-2
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author Iida, Shinsuke
Ishikawa, Takayuki
Min, Chang Ki
Kim, Kihyun
Yeh, Su Peng
Usmani, Saad Z.
Mateos, Maria-Victoria
Nahi, Hareth
Heuck, Christoph
Qin, Xiang
Parasrampuria, Dolly A.
Gries, Katharine S.
Qi, Ming
Bahlis, Nizar
Ito, Shigeki
author_facet Iida, Shinsuke
Ishikawa, Takayuki
Min, Chang Ki
Kim, Kihyun
Yeh, Su Peng
Usmani, Saad Z.
Mateos, Maria-Victoria
Nahi, Hareth
Heuck, Christoph
Qin, Xiang
Parasrampuria, Dolly A.
Gries, Katharine S.
Qi, Ming
Bahlis, Nizar
Ito, Shigeki
author_sort Iida, Shinsuke
collection PubMed
description The phase 3 COLUMBA study demonstrated noninferiority of subcutaneous daratumumab (DARA SC) to intravenous daratumumab (DARA IV) in relapsed or refractory multiple myeloma. We present a subgroup analysis of Asian patients from COLUMBA. Eligible patients had ≥ 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, or were double refractory. Co-primary endpoints were overall response rate (ORR) and maximum trough concentration (C(trough)). Secondary endpoints included rates of infusion-related reactions, progression-free survival, and patient-reported satisfaction with therapy. Sixty-seven Asian patients (DARA SC, n = 30; DARA IV, n = 37) were randomized, including 42 Japanese patients (DARA SC, n = 18; DARA IV, n = 24). Comparable ORRs for DARA SC versus DARA IV were seen in the Asian cohort (66.7% vs 43.2%) and Japanese-only cohort (61.1% vs 54.2%), including patients weighing ≤ 65 kg. Similarity of C(trough) was seen in both Asian and Japanese-only cohorts; the ratio of the geometric mean of the C(trough) concentrations for DARA SC/DARA IV was 143.96% (90% confidence interval (CI), 112.03–185.00%) and 148.02% (90% CI, 113.32–193.34%), respectively. The Asian cohort (both treatment groups) and Japanese-only cohort (DARA SC group) experienced higher rates of grade 3/4 cytopenias compared with the global COLUMBA population, occurring predominantly in patients of low bodyweight; no patients discontinued treatment due to cytopenias. The Cancer Therapy Satisfaction Questionnaire results generally favored DARA SC. In the Asian and Japanese-only cohorts, DARA SC was comparable to DARA IV. The efficacy, pharmacokinetic, safety, and satisfaction results were generally consistent with the global COLUMBA population regardless of patient bodyweight. ClinicalTrials.gov Identifier: NCT03277105 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00277-021-04405-2.
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spelling pubmed-79606122021-04-01 Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study Iida, Shinsuke Ishikawa, Takayuki Min, Chang Ki Kim, Kihyun Yeh, Su Peng Usmani, Saad Z. Mateos, Maria-Victoria Nahi, Hareth Heuck, Christoph Qin, Xiang Parasrampuria, Dolly A. Gries, Katharine S. Qi, Ming Bahlis, Nizar Ito, Shigeki Ann Hematol Original Article The phase 3 COLUMBA study demonstrated noninferiority of subcutaneous daratumumab (DARA SC) to intravenous daratumumab (DARA IV) in relapsed or refractory multiple myeloma. We present a subgroup analysis of Asian patients from COLUMBA. Eligible patients had ≥ 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug, or were double refractory. Co-primary endpoints were overall response rate (ORR) and maximum trough concentration (C(trough)). Secondary endpoints included rates of infusion-related reactions, progression-free survival, and patient-reported satisfaction with therapy. Sixty-seven Asian patients (DARA SC, n = 30; DARA IV, n = 37) were randomized, including 42 Japanese patients (DARA SC, n = 18; DARA IV, n = 24). Comparable ORRs for DARA SC versus DARA IV were seen in the Asian cohort (66.7% vs 43.2%) and Japanese-only cohort (61.1% vs 54.2%), including patients weighing ≤ 65 kg. Similarity of C(trough) was seen in both Asian and Japanese-only cohorts; the ratio of the geometric mean of the C(trough) concentrations for DARA SC/DARA IV was 143.96% (90% confidence interval (CI), 112.03–185.00%) and 148.02% (90% CI, 113.32–193.34%), respectively. The Asian cohort (both treatment groups) and Japanese-only cohort (DARA SC group) experienced higher rates of grade 3/4 cytopenias compared with the global COLUMBA population, occurring predominantly in patients of low bodyweight; no patients discontinued treatment due to cytopenias. The Cancer Therapy Satisfaction Questionnaire results generally favored DARA SC. In the Asian and Japanese-only cohorts, DARA SC was comparable to DARA IV. The efficacy, pharmacokinetic, safety, and satisfaction results were generally consistent with the global COLUMBA population regardless of patient bodyweight. ClinicalTrials.gov Identifier: NCT03277105 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s00277-021-04405-2. Springer Berlin Heidelberg 2021-02-18 2021 /pmc/articles/PMC7960612/ /pubmed/33599794 http://dx.doi.org/10.1007/s00277-021-04405-2 Text en © The Author(s) 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Original Article
Iida, Shinsuke
Ishikawa, Takayuki
Min, Chang Ki
Kim, Kihyun
Yeh, Su Peng
Usmani, Saad Z.
Mateos, Maria-Victoria
Nahi, Hareth
Heuck, Christoph
Qin, Xiang
Parasrampuria, Dolly A.
Gries, Katharine S.
Qi, Ming
Bahlis, Nizar
Ito, Shigeki
Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study
title Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study
title_full Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study
title_fullStr Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study
title_full_unstemmed Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study
title_short Subcutaneous daratumumab in Asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 COLUMBA study
title_sort subcutaneous daratumumab in asian patients with heavily pretreated multiple myeloma: subgroup analyses of the noninferiority, phase 3 columba study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7960612/
https://www.ncbi.nlm.nih.gov/pubmed/33599794
http://dx.doi.org/10.1007/s00277-021-04405-2
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