Patient-reported Outcomes and Healthcare Provider Perspectives on Subcutaneous Isatuximab Delivery via On-body Injector Versus Manual Injection: Results From the Phase 2 IZALCO Study in Relapsed/Refractory Multiple Myeloma.

BACKGROUND: The phase 2 IZALCO study (NCT05704049) demonstrated comparable efficacy, safety, and pharmacokinetics for subcutaneous (SC) isatuximab administered via an on-body injector (Isa SC OBI) versus manual injection in combination with carfilzomib-dexamethasone in relapsed/refractory multiple myeloma. PATIENTS AND METHODS: We evaluated patient-reported outcomes (PROs) in 74 adults and experiences of 19 healthcare providers (HCPs) from IZALCO. In part 1, Isa was given via manual injection. In part 2, patients were randomly assigned to manual injection or Isa SC OBI in cycle (C)1-3 and crossed over to the other method for C4-6. From C7, patients could select either method. Patient preference of delivery method at C6 Day (D)15 was a key secondary endpoint (n = 47). PROs and HCP experience were assessed using the Patient Expectations Questionnaire, Patient Experience and Satisfaction Questionnaire, European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), and HCP questionnaire. RESULTS: In part 2, at C6D15, after experiencing both methods, 74.5% (35/47) of patients preferred Isa SC OBI over manual injection, with comfort, convenience, and reduced injection-site pain being the main reasons for preference. Fewer patients reported discomfort, pain, and side effects with Isa SC OBI versus manual injection at most time points. Most patients (90.4%, 47/52) opted for Isa SC OBI from C7 onward. Mean EORTC QLQ-C30 global health status/QoL score was maintained over time. Of 19 HCPs, 78.9% (15/19) preferred Isa SC OBI versus manual injection. CONCLUSION: These findings support Isa SC OBI as the preferred administration method for patients and HCPs.