Efficacy and safety of isatuximab plus bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma ineligible/with no immediate intent for autologous stem cell transplantation

Ocio, E.M. (Enrique M.); Perrot, A. (Aurore); Bories, P. (Pierre); San-Miguel, J.F. (Jesús F.); Blau, I.W. (Igor W.); Karlin, L. (Lionel); Martínez-López, J. (Joaquín); Wang, S.Y. (Song Yau); Bringhen, S. (Sara); Marcatti, M. (Magda); Mateos, M.V. (María Victoria); Rodriguez-Otero, P. (Paula); Oliva, S. (Stefania); Nogai, A. (Axel); Le-Roux, N. (Nadia); Dong, L. (Liyan); Mace, S. (Sandrine); Gassiot, M. (Matthieu); Fitzmaurice, T. (Thomas); Oprea, C. (Corina); Moreau, P. (Philippe)

Palabras clave :

Newly diagnosed multiple myeloma (NDMM)
Autologous stem cell transplantation (ASCT)
Pharmacokinetics (PK)
Isatuximab

Fecha de publicación :

2023

Versión del Editor:

https://pubmed.ncbi.nlm.nih.gov/37316728/

ISSN :

0887-6924

Nota:

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/.

Cita:

Ocio, E. M.; Perrot, A.; Bories, P.; et al. "Efficacy and safety of isatuximab plus bortezomib, lenalidomide, and dexamethasone in patients with newly diagnosed multiple myeloma ineligible/with no immediate intent for autologous stem cell transplantation". Leukemia. 37 (7), 2023, 1521 - 1529

Resumen

Patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplantation (ASCT) have lower survival rates and may benefit from frontline regimens that include novel agents. This Phase 1b study (NCT02513186) evaluated preliminary efficacy, safety, and pharmacokinetics (PK) of isatuximab, an anti-CD38 monoclonal antibody, combined with bortezomib-lenalidomide-dexamethasone (Isa-VRd) in patients with NDMM ineligible for/with no intent for immediate ASCT. Overall, 73 patients received four 6-week induction cycles of Isa-VRd, then maintenance with Isa-Rd in 4-week cycles. In the efficacy population (n = 71), the overall response rate was 98.6%, with 56.3% achieving a complete response or better (sCR/CR), and 36/71 (50.7%) patients reaching minimal residual disease negativity (10(-5) sensitivity). Grade >= 3 treatment-emergent adverse events (TEAEs) occurred in 79.5% (58/73) of patients but TEAEs leading to permanent study treatment discontinuation were reported in 14 (19.2%) patients. Isatuximab PK parameters were within the previously reported range, suggesting that VRd does not alter the PK of isatuximab. These data support additional studies of isatuximab in NDMM, such as the Phase 3 IMROZ study (Isa-VRd vs VRd).

URI :

https://hdl.handle.net/10171/67554

DOI:

10.1038/s41375-023-01936-7

Aparece en las colecciones:

DA - CUN - Hematología y Hemoterapia - Artículos de revista

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