IZALCO & IRAKLIA

At the 2025 annual IMS meeting, several presentations highlighted the use of the new on-body injector (OBI) designed to facilitate the administration of the subcutaneous (SC) formulation of isatuximab. In this video, Prof Vania Hungria, haematologist at the Clínica São Germano in São Paulo, Brazil, shares the key takeaways.

The Phase II IZALCO study evaluated the efficacy (primary endpoint), patient preference, safety, and pharmacokinetics (PK) of isatuximab SC administered either by manual injection or via the OBI, in combination with carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma (RRMM).

The first poster from IZALCO confirmed comparable efficacy, safety, and PK profiles for Isa SC given by manual injection or via the OBI. However, patients expressed a clear preference for the OBI. A second poster focused on patient experience showed that Isa SC administration with the OBI was associated with less discomfort, reduced pain, fewer side effects, and a high rate of treatment satisfaction.

In addition, Prof Xavier Leleu presented updated results from the Phase III IRAKLIA trial, which compared Isa SC (OBI) versus Isa administered intravenously (IV), both in combination with pomalidomide-dexamethasone (Pd), in RRMM patients. The trial demonstrated comparable efficacy and safety between both regimens, but with a markedly lower incidence of infusion reactions in the Isa SC arm. Importantly, Isa SC via OBI was also associated with significantly higher patient satisfaction compared to the conventional IV approach.