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.

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

Clinical Haematology Service St Vincent's Hospital University of Melbourne Melbourne VIC Australia

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

Department of Haemato Oncology University Hospital Ostrava and Faculty of Medicine University of Ostrava Ostrava Czech Republic

Department of Hemato Oncology Faculty of Medicine and Dentistry Palacký University and University Hospital Olomouc Olomouc Czech Republic

Department of Hematology and Bone Marrow Transplantation Unit Evangelismos General Hospital Athens Greece

Department of Hematology and Experimental Therapeutics National Cancer Center Hospital East Kashiwa Japan

Department of Hematology and Oncology Clínica São Germano São Paulo Brazil

Department of Hematology Hospital de Braga Academic Clinical Center of Braga Braga and CINTESIS Oporto University Braga Portugal

Department of Hematology NHO Okayama Medical Center Okayama Japan

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

Department of Medicine Korea University Seoul South Korea

Departments of Medicine and Hematology 1st Faculty of Medicine Charles University and General Hospital Prague Czech Republic

Excelya on Behalf of Sanofi Research and Development Vitry sur Seine France

Hematologia e Hemoterapia do Hospital das Clinicas FMUSP São Paulo Brazil

Hospital de Santa Maria Centro de Investigação Clínica Lisboa Portugal

Illawarra Cancer Care Centre Wollongong Hospital University of Wollongong Wollongong NSW Australia

Sanofi Research and Development Cambridge MA USA

Sanofi Research and Development Reading UK

Sanofi Research and Development Vitry sur Seine France

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ClinicalTrials.gov
NCT05704049