IRAKLIA study

The international, non-inferiority, open-label phase III IRAKLIA trial evaluated a subcutaneous (SC) formulation of isatuximab (Isa) delivered via an innovative on-body injection device (OBI), compared to the standard intravenous (IV) formulation. Both forms were administered in combination with pomalidomide and dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma (RRMM) who had previously been treated with lenalidomide and a proteasome inhibitor.

The OBI is a wearable, hands-free device that enables controlled and sustained delivery of Isa directly through the skin. This novel mode of administration is designed to enhance patient convenience, reduce clinic time, and lower the incidence of infusion-related reactions (IRRs).

Earlier this year, data from the IRAKLIA trial, presented at ASCO and published in the Journal of Clinical Oncology—demonstrated non-inferior efficacy and comparable pharmacokinetics between the SC OBI and IV formulations of Isa. Safety profiles were also similar, although the OBI was associated with a lower rate of IRRs. Subgroup analyses, presented at IMS 2025, confirmed that outcomes with Isa SC via OBI + Pd were consistent with those of Isa IV + Pd, regardless of the number of prior treatment lines.¹

A second IRAKLIA poster presented at IMS focused on patient-reported outcomes, comparing the experience of receiving Isa via the OBI versus IV infusion. Patients in the OBI group reported less discomfort, reduced pain, fewer side effects, and notable time savings. Overall, this analysis suggested higher treatment satisfaction among patients treated with the OBI, further reinforcing its value in clinical practice.²

According to Prof Claudio Cerchione, haematologist at the Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori in Meldola (Italy), these findings are highly relevant—particularly given the growing role of isatuximab in the evolving therapeutic landscape of multiple myeloma.