Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in elderly patients with relapsed multiple myeloma : IKEMA subgroup analysis
Facon, Thierry (Lille University Hospital)
Moreau, Philippe (University of Nantes)
Martin, Thomas G. (University of California San Francisco)
Spicka, Ivan (Charles University and General Hospital, Prague, Czech Republic)
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Koh, Youngil (Seoul National University Hospital, South Korea)
Lim, Andrew (Austin & Repatriation Medical Center, Heidelberg, Victoria, Australia)
Mikala, Gabor (South Pest Central Hospital, Budapest, Hungary)
Rosiñol, Laura (Hospital Clínic i Provincial de Barcelona)
Yağci, Münci (Gazi University, Ankara, Turkey)
Cavo, Michele (Bologna University School of Medicine, Italy)
Yong, Kwee (University College Hospital, London, UK)
Risse, Marie Laure (Sanofi R&D, Vitry-Sur-Seine, France)
Asset, Gaëlle (Sanofi R&D, Chilly-Mazarin, France)
Schwab, Sandrine (Sanofi R&D, Chilly-Mazarin, France)
Martinez, Gracia (Hospital das Clínicas de São Paulo, Brazil)

Date:	2022
Abstract:	In this subgroup analysis of the randomized, Phase 3 IKEMA study (NCT03275285), we evaluated efficacy and safety of the anti-CD38 monoclonal antibody isatuximab (Isa) in combination with carfilzomib-dexamethasone (Isa-Kd) versus Kd in older (≥70 years of age, n = 86) and younger (<70 years, n = 216) patients with relapsed multiple myeloma (MM). Patients received Isa 10 mg/kg intravenously weekly for 4 weeks, then every 2 weeks in the Isa-Kd arm, and approved schedule of carfilzomib (twice weekly) and dexamethasone in both study arms. Primary endpoint was progression-free survival (PFS); key secondary efficacy endpoints included rates of overall response (ORR), very good partial response or better (≥VGPR), minimal residual disease negativity (MRD-), and complete response (CR). Addition of Isa to Kd resulted in improved PFS in elderly patients (hazard ratio, 0. 36 [95% CI, 0. 18-0. 75]) consistent with the significant PFS improvement observed in the overall IKEMA population. Treatment with Isa-Kd improved depth of response versus Kd, with higher rates of ≥VGPR (73. 1% vs. 55. 9%), MRD- (23. 1% vs. 11. 8%), and CR (38. 5% vs. 23. 5%). Although the incidence of grade ≥3 treatment-emergent adverse events (TEAEs) was higher in Isa-Kd, the incidence of serious TEAEs was similar between arms. Fewer elderly patients definitively discontinued treatment due to TEAEs in Isa-Kd than Kd: 11. 8% versus 23. 5%. In conclusion, Isa-Kd provides a consistent benefit versus Kd in elderly patients, with a manageable safety profile, and represents a new treatment option for patients with relapsed MM, independent of age.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	CD38 ; Elderly ; Isatuximab ; Monoclonal antibody ; Multiple myeloma
Published in:	Hematological Oncology, Vol. 40 Núm. 5 (december 2022) , p. 1020-1029, ISSN 1099-1069

DOI: 10.1002/hon.3038
PMID: 35653225

10 p, 496.7 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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