Efficacy and safety of isatuximab subcutaneous plus carfilzomib and dexamethasone in patients with relapsed/refractory multiple myeloma: results of the Phase 2 study IZALCO

In the Phase 2 IZALCO study, we evaluated efficacy, patient preference, safety and pharmacokinetics for isatuximab administered SC by an innovative on-body injector (OBI) or manual injection, plus carfilzomib-dexamethasone (Kd) in relapsed/refractory multiple myeloma (RRMM) patients. In Part 1, isatuximab SC was injected manually (cycles 1-6). In Part 2, patients were randomized to isatuximab SC by manual injection (cycles 1-3) followed by OBI administration (cycles 4-6) or to isatuximab OBI (cycles 1-3) followed by manual injection (cycles 4-6). From cycle 7, all patients could choose either treatment method. Overall, 74 RRMM patients received isatuximab SC plus Kd: 8 in Part 1 and 66 in Part 2. The patients had a median age of 65.0 years (44-85) with a median of 1 prior treatment line (1-5). The study met its primary efficacy endpoint with a 79.7% overall response rate (N = 74), at a median follow-up of 10.1 months. 74.5% of patients preferred the OBI rather than manual injection, 17% preferred manual injection, 8.5% had no preference. No impact of the SC delivery method was observed on efficacy, safety, pharmacokinetics, and immunogenicity of isatuximab given SC plus Kd, supporting the feasibility of using the OBI as a convenient method for isatuximab SC administration. Clinical trial information: ClinicalTrials.gov NCT05704049.