Renal impairment (RI) is common in patients with multiple myeloma (MM) and new therapies that can improve renal function are needed. The phase III IKEMA study (clinicaltrials gov. Identifier: NCT03275285) investigated isatuximab (Isa) with carfilzomib and dexamethasone (Kd) versus Kd in relapsed MM. This subgroup analysis examined results from patients with RI, defined as estimated glomerular filtration rate <60 mL/min/1.73 m². Addition of Isa prolonged progression-free survival (PFS) in patients with RI (hazard ratio: 0.27; 95% confidence interval [CI]: 0.11-0.66; median PFS not reached for Isa-Kd versus 13.4 months for Kd [20.8-month follow-up]). Complete renal responses occurred more frequently with Isa-Kd (52.0%) versus Kd (30.8%) and were durable in 32.0% versus 7.7% of patients, respectively. Treatment exposure was longer with Isa-Kd, with median number of started cycles and median duration of exposure of 20 versus 9 cycles and 81.0 versus 35.7 weeks for Isa-Kd versus Kd, respectively. Among patients with RI, the incidence of patients with grade ≥3 treatment-emergent adverse events was similar between the two arms (79.1% in Isa-Kd vs. 77.8% in Kd). In summary, the addition of Isa to Kd improved clinical outcomes with a manageable safety profile in patients with RI, consistent with the benefit observed in the overall IKEMA study population.

Aixial Boulogne Billancourt

Centro Integrado de Hematologia e Oncologia Hospital Mãe de Deus Porto Alegre

Department of Clinical Therapeutics School of Medicine National and Kapodistrian University of Athens School of Medicine Athens

Department of Hematology Catholic Hematology Hospital and Leukemia Research Institute Seoul St Mary's Hospital College of Medicine The Catholic University of Korea Seoul

Department of Hematology Hôpital Saint Antoine Sorbonne University INSERM UMRs 938 Paris

Department of Hematology Ondokuz Mayıs University Faculty of Medicine Samsun

Department of Hematology University of Nantes Nantes

Department of Internal Medicine Hematology and Oncology University Hospital Brno Brno Czech Republic

Department of Medicine University of California at San Francisco San Francisco CA

Hôpital Maisonneuve Rosemont Université de Montréal

Hospital Universitario Virgen del Rocio Sevilla

Perth Blood Institute Murdoch University Perth

Sanofi Research and Development Vitry Alfortville

Service d'Hématologie et Thérapie Cellulaire CHU and CIC Inserm 1402 Poitiers Cedex

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Monoclonal Antibodies and Antibody Drug Conjugates in Multiple Myeloma