Isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma patients with high-risk cytogenetics

Introduction: The presence of high-risk chromosomal abnormalities [t(4;14), del(17p), and t(14;16)] has been linked with inferior outcomes in patients with multiple myeloma (MM). A prespecified interim analysis of the Phase 3 IKEMA study (NCT03275285) demonstrated that isatuximab (Isa) + carfilzomib...

ver descrição completa

Detalhes bibliográficos
Autores: Spicka, Ivan, Moreau, Philippe|||0000-0003-1780-8746, Martin, Thomas G., Facon, Thierry, Martínez, Gracia, Oriol, Albert|||0000-0001-6804-2221, Koh, Youngil, Lim, Andrew, Mikala, Gabor|||0000-0003-2204-7398, Rosiñol, Laura|||0000-0002-2534-9239, Yağci, Münci, Cavo, Michele, Risse, Marie-Laure, Asset, Gaëlle, Macé, Sandrine, Van de Velde, Helgi, Yong, Kwee|||0000-0002-6487-276X
Tipo de documento: artigo
Data de publicação:2022
País:España
Recursos:Universitat Autònoma de Barcelona
Repositório:Dipòsit Digital de Documents de la UAB
Idioma:inglês
OAI Identifier:oai:ddd.uab.cat:270517
Acesso em linha:https://ddd.uab.cat/record/270517
https://dx.doi.org/urn:doi:10.1111/ejh.13835
Access Level:Acceso aberto
Descrição
Resumo:Introduction: The presence of high-risk chromosomal abnormalities [t(4;14), del(17p), and t(14;16)] has been linked with inferior outcomes in patients with multiple myeloma (MM). A prespecified interim analysis of the Phase 3 IKEMA study (NCT03275285) demonstrated that isatuximab (Isa) + carfilzomib (K) and dexamethasone (d; Isa-Kd) significantly improved progression-free survival (PFS) versus Kd in patients with relapsed MM. This prespecified subgroup analysis of IKEMA examined efficacy and safety in patients with high-risk cytogenetics. Methods: High-risk cytogenetics was assessed by central laboratory and patients were classified as high risk if abnormalities were present in ≥1 of the following: del(17p): 50% cutoff; t(4;14), and/or t(14;16): 30% cutoff. Results: Of the randomized patients, 23.5% (Isa-Kd) and 25.2% (Kd) had ≥1 high-risk chromosomal abnormality. A PFS benefit was seen in favor of Isa-Kd for patients with standard-risk (HR 0.440; 95% CI 0.266-0.728) and high-risk cytogenetics (HR 0.724; 95% CI 0.361-1.451). Grade ≥3 treatment-emergent adverse events (TEAEs) were more common with Isa-Kd (85.7%) versus Kd (63.3%) in patients with high-risk cytogenetics; however, the incidence of serious TEAEs (64.3% vs. 66.7%) was similar. Conclusions: Isa-Kd is a new treatment option for the difficult-to-treat subgroup of patients with relapsed MM and high-risk cytogenetics

Registros relacionados