Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients with renal impairment: IKEMA subgroup analysis
Marcelo Capra,
Thomas Martin,
Philippe Moreau,
Ross Baker,
Ludek Pour,
Chang-Ki Min,
Xavier Leleu,
Mohamad Mohty,
Marta Reinoso Segura,
Mehmet Turgut,
Richard LeBlanc,
Marie-Laure Risse,
Laure Malinge,
Sandrine Schwab,
Meletios Dimopoulos
Affiliations
Marcelo Capra
Centro Integrado de Hematologia e Oncologia, Hospital Mãe de Deus, Porto Alegre
Thomas Martin
Department of Medicine, University of California at San Francisco, San Francisco, CA
Philippe Moreau
Department of Hematology, University of Nantes, Nantes
Ross Baker
Perth Blood Institute, Murdoch University, Perth
Ludek Pour
Department of Internal Medicine, Hematology and Oncology, University Hospital Brno, Brno, Czech Republic
Chang-Ki Min
Department of Hematology, Catholic Hematology Hospital and Leukemia Research Institute, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul
Xavier Leleu
Service d'Hématologie et Thérapie Cellulaire, CHU and CIC Inserm 1402, Poitiers Cedex
Mohamad Mohty
Department of Hematology, Hôpital Saint-Antoine, Sorbonne University, INSERM UMRs 938, Paris
Marta Reinoso Segura
Hospital Universitario Virgen del Rocio, Sevilla
Mehmet Turgut
Department of Hematology, Ondokuz Mayıs University Faculty of Medicine, Samsun
Richard LeBlanc
Hôpital Maisonneuve-Rosemont, Université de Montréal
Marie-Laure Risse
Sanofi Research and Development, Vitry/Alfortville
Laure Malinge
Aixial, Boulogne-Billancourt
Sandrine Schwab
Sanofi Research and Development, Vitry/Alfortville
Meletios Dimopoulos
Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens School of Medicine, Athens
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.
