Clinical Efficacy of Isatuximab Plus Carfilzomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients
- Authors: De Novellis, Danilo; Derudas, Daniele; Vincelli, Donatella; Fontana, Raffaele; Della Pepa, Roberta; Palmieri, Salvatore; Accardi, Fabrizio; Rotondo, Francesco; Morelli, Emanuela; Gigliotta, Emilia; Roccotelli, Daniela; Marano, Luana; Barone, Maria Lucia; Cetani, Giusy; Esposito, Daniela; Lazzaro, Antonio; Delle Cave, Giuseppe; Serio, Bianca; Morini, Denise; Porrazzo, Marika; Urciuoli, Eleonora; Masucci, Chiara; Fanelli, Fulvia; Rizzo, Michela; Arcamone, Manuela; Trastulli, Fabio; Rocco, Stefano; Leone, Aldo; Bianco, Rosario; Salvatore, Flavia; Idato, Aurora; Sicari, Maria; Tosi, Patrizia; Rascato, Maria Gabriella; Di Perna, Maria; Falcone, Antonietta Pia; Morello, Lucia; Carlisi, Melania; Svanera, Gino; Annunziata, Mario; Frigeri, Ferdinando; Califano, Catello; Carella, Angelo Michele; Marcacci, Gianpaolo; Pane, Fabrizio; Risitano, Antonio Maria; Giudice, Valentina; Botta, Cirino; Selleri, Carmine
- Publication year: 2024
- Type: Articolo in rivista
- OA Link: http://hdl.handle.net/10447/659375
Abstract
Isatuximab, a novel anti-CD38 monoclonal antibody, is approved in combination with carfilzomib and dexamethasone (Isa-Kd) in relapsed/refractory multiple myeloma (RRMM) patients. Because of its recent introduction, real-world efficacy and safety are poorly reported. In this Italian multicenter real-life observational retrospective study, efficacy and safety of the Isa-Kd regimen were evaluated in a cohort of 103 RRMM patients. Overall response rate (ORR) was 85%, with stringent (sCR) or complete response (CR) in 18% of cases and very good partial response (VGPR) in 39%. Median PFS and OS were not reached within the study period, while 1-year PFS and OS were 72% and 77%, respectively. Hematological toxicities were observed in 42% of subjects, and cardiac toxicities occurred in 24% of cases. Moreover, we conducted a subanalysis on patients (N = 69) treated with Isa-Kd after one prior line of therapy, showing an ORR of 88%, with sCR + CR in 20% of subjects, VGPR in 46%, and PR in 22% of patients. In this group, median PFS and OS were not reached, while 1-year PFS and OS were 92% and 95%, respectively. In conclusions, our study confirmed Isa-Kd as an effective treatment option for RRMM with a manageable safety profile even in real-life settings.