Isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma patients with high-risk cytogenetics : IKEMA subgroup analysis
Spicka, Ivan (Charles University and General Hospital)
Moreau, Philippe (University of Nantes)
Martin, Thomas G. (University of California San Francisco)
Facon, Thierry (Lille University Hospital)
Martínez, Gracia (Hospital das Clínicas de Faculdade de Medicina da Universidade de São Paulo)
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Koh, Youngil (Seoul National University Hospital)
Lim, Andrew (Austin and Repatriation Medical Center)
Mikala, Gabor (South Pest Central Hospital)
Rosiñol, Laura (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Yağci, Münci (Gazi University)
Cavo, Michele (Università di Bologna)
Risse, Marie-Laure (Sanofi (França))
Asset, Gaëlle (Sanofi (França))
Macé, Sandrine (Sanofi (França))
Van de Velde, Helgi (Sanofi)
Yong, Kwee (University College Hospital)
Universitat Autònoma de Barcelona

Date:	2022
Abstract:	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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	European Journal of Haematology, Vol. 109 Núm. 5 (november 2022) , p. 504-512, ISSN 1600-0609

DOI: 10.1111/ejh.13835
PMID: 35871357

9 p, 982.6 KB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP) > Josep Carreras Leukaemia Research Institute
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