Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/30280
Title: Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in elderly patients with relapsed multiple myeloma: IKEMA subgroup analysis.
Austin Authors: Facon, Thierry;Moreau, Philippe;Martin, Thomas G;Spicka, Ivan;Oriol, Albert;Koh, Youngil;Lim, Andrew Boon Ming ;Mikala, Gabor;Rosiñol, Laura;Yağci, Münci;Cavo, Michele;Yong, Kwee;Risse, Marie-Laure;Asset, Gaëlle;Schwab, Sandrine;Martinez, Gracia
Affiliation: Repatriation Medical Center, Heidelberg, Victoria, Australia..
Department of Haematology, Lille University Hospital, Lille, France..
University of Nantes, Nantes, France..
University of California San Francisco, San Francisco, California, USA..
Departments of Medicine and Hematology, First Faculty of Medicine, Charles University and General Hospital, Prague, Czech Republic..
Hematology Department, Institut Català d'Oncologia and Josep Carreras Institute, Hospital Germans Trias i Pujol, Barcelona, Spain..
Seoul National University Hospital, Seoul, South Korea..
Department of Hematology and Stem Cell Transplantation, National Institute for Hematology and Infectious Diseases, South Pest Central Hospital, Budapest, Hungary..
Hospital Clinic, IDIBAPS, Barcelona, Spain..
Gazi University, Ankara, Turkey..
IRCCS Azienda Ospedaliero-Universitaria di Bologna, "Seràgnoli" Institute of Hematology, Bologna University School of Medicine, Bologna, Italy..
Department of Haematology, University College Hospital, London, UK..
Sanofi R&D, Vitry-Sur-Seine, France..
Sanofi R&D, Chilly-Mazarin, France..
Hospital das Clínicas de São Paulo, São Paolo, Brazil..
Austin Health
Issue Date: 2-Jun-2022
Date: 2022
Publication information: Hematological Oncology 2022; 40(5)
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.
URI: https://ahro.austin.org.au/austinjspui/handle/1/30280
DOI: 10.1002/hon.3038
Journal: Hematological oncology
PubMed URL: 35653225
PubMed URL: https://pubmed.ncbi.nlm.nih.gov/35653225/
Type: Journal Article
Subjects: CD38
elderly
isatuximab
monoclonal antibody
multiple myeloma
Appears in Collections:Journal articles

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