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Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial

Idecabtagene vicleucel (ide-cel) is a B-cell-maturation antigen (BCMA)-directed chimeric antigen receptor T cell therapy. We performed a post hoc analysis of a single-arm phase 1 multicenter study in relapsed/refractory multiple myeloma (CRB-401) (n = 62; median follow-up, 18.1 months). The primary...

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Autores principales: Lin, Yi, Raje, Noopur S., Berdeja, Jesús G., Siegel, David S., Jagannath, Sundar, Madduri, Deepu, Liedtke, Michaela, Rosenblatt, Jacalyn, Maus, Marcela V., Massaro, Monica, Petrocca, Fabio, Yeri, Ashish, Finney, Olivia, Caia, Andrea, Yang, Zhihong, Martin, Nathan, Campbell, Timothy B., Rytlewski, Julie, Fuller, Jaymes, Hege, Kristen, Munshi, Nikhil C., Kochenderfer, James N.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Nature Publishing Group US 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10504071/
https://www.ncbi.nlm.nih.gov/pubmed/37592106
http://dx.doi.org/10.1038/s41591-023-02496-0
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author Lin, Yi
Raje, Noopur S.
Berdeja, Jesús G.
Siegel, David S.
Jagannath, Sundar
Madduri, Deepu
Liedtke, Michaela
Rosenblatt, Jacalyn
Maus, Marcela V.
Massaro, Monica
Petrocca, Fabio
Yeri, Ashish
Finney, Olivia
Caia, Andrea
Yang, Zhihong
Martin, Nathan
Campbell, Timothy B.
Rytlewski, Julie
Fuller, Jaymes
Hege, Kristen
Munshi, Nikhil C.
Kochenderfer, James N.
author_facet Lin, Yi
Raje, Noopur S.
Berdeja, Jesús G.
Siegel, David S.
Jagannath, Sundar
Madduri, Deepu
Liedtke, Michaela
Rosenblatt, Jacalyn
Maus, Marcela V.
Massaro, Monica
Petrocca, Fabio
Yeri, Ashish
Finney, Olivia
Caia, Andrea
Yang, Zhihong
Martin, Nathan
Campbell, Timothy B.
Rytlewski, Julie
Fuller, Jaymes
Hege, Kristen
Munshi, Nikhil C.
Kochenderfer, James N.
author_sort Lin, Yi
collection PubMed
description Idecabtagene vicleucel (ide-cel) is a B-cell-maturation antigen (BCMA)-directed chimeric antigen receptor T cell therapy. We performed a post hoc analysis of a single-arm phase 1 multicenter study in relapsed/refractory multiple myeloma (CRB-401) (n = 62; median follow-up, 18.1 months). The primary endpoint was safety outcomes, and secondary endpoints included overall response rate (ORR), complete response (CR) and very good partial response (VGPR). The study met its primary endpoint with low rates of grade 3/grade 4 cytokine release syndrome (6.5%) and neurotoxicity (1.6%). ORR was 75.8%; 64.5% achieved VGPR or better and 38.7% achieved CR or stringent CR. Among exploratory endpoints, median duration of response, progression-free survival (PFS) and overall survival were 10.3, 8.8 and 34.2 months, respectively, and ide-cel expansion in blood and bone marrow correlated with clinical efficacy and postinfusion reduction of soluble BCMA. Patients with PFS ≥ 18 months had more naive and less exhausted T cells in apheresis material and improved functional T cell phenotype in the drug product compared with those with less durable responses. These results confirm ide-cel safety, tolerability and efficacy and describe T cell qualities that correlate with durable response. Clinicaltrials.gov identifier : NCT02658929.
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spelling pubmed-105040712023-09-17 Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial Lin, Yi Raje, Noopur S. Berdeja, Jesús G. Siegel, David S. Jagannath, Sundar Madduri, Deepu Liedtke, Michaela Rosenblatt, Jacalyn Maus, Marcela V. Massaro, Monica Petrocca, Fabio Yeri, Ashish Finney, Olivia Caia, Andrea Yang, Zhihong Martin, Nathan Campbell, Timothy B. Rytlewski, Julie Fuller, Jaymes Hege, Kristen Munshi, Nikhil C. Kochenderfer, James N. Nat Med Article Idecabtagene vicleucel (ide-cel) is a B-cell-maturation antigen (BCMA)-directed chimeric antigen receptor T cell therapy. We performed a post hoc analysis of a single-arm phase 1 multicenter study in relapsed/refractory multiple myeloma (CRB-401) (n = 62; median follow-up, 18.1 months). The primary endpoint was safety outcomes, and secondary endpoints included overall response rate (ORR), complete response (CR) and very good partial response (VGPR). The study met its primary endpoint with low rates of grade 3/grade 4 cytokine release syndrome (6.5%) and neurotoxicity (1.6%). ORR was 75.8%; 64.5% achieved VGPR or better and 38.7% achieved CR or stringent CR. Among exploratory endpoints, median duration of response, progression-free survival (PFS) and overall survival were 10.3, 8.8 and 34.2 months, respectively, and ide-cel expansion in blood and bone marrow correlated with clinical efficacy and postinfusion reduction of soluble BCMA. Patients with PFS ≥ 18 months had more naive and less exhausted T cells in apheresis material and improved functional T cell phenotype in the drug product compared with those with less durable responses. These results confirm ide-cel safety, tolerability and efficacy and describe T cell qualities that correlate with durable response. Clinicaltrials.gov identifier : NCT02658929. Nature Publishing Group US 2023-08-17 2023 /pmc/articles/PMC10504071/ /pubmed/37592106 http://dx.doi.org/10.1038/s41591-023-02496-0 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/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 license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license 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 license, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Article
Lin, Yi
Raje, Noopur S.
Berdeja, Jesús G.
Siegel, David S.
Jagannath, Sundar
Madduri, Deepu
Liedtke, Michaela
Rosenblatt, Jacalyn
Maus, Marcela V.
Massaro, Monica
Petrocca, Fabio
Yeri, Ashish
Finney, Olivia
Caia, Andrea
Yang, Zhihong
Martin, Nathan
Campbell, Timothy B.
Rytlewski, Julie
Fuller, Jaymes
Hege, Kristen
Munshi, Nikhil C.
Kochenderfer, James N.
Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial
title Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial
title_full Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial
title_fullStr Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial
title_full_unstemmed Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial
title_short Idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial
title_sort idecabtagene vicleucel for relapsed and refractory multiple myeloma: post hoc 18-month follow-up of a phase 1 trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10504071/
https://www.ncbi.nlm.nih.gov/pubmed/37592106
http://dx.doi.org/10.1038/s41591-023-02496-0
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