IZALCO: SC isatuximab via OBI or manual injection + Kd for RRMM

Results from the phase II IZALCO (NCT05704049) study, evaluating subcutaneous (SC) isatuximab, administered by either manual injection or on-body injector (OBI), with carfilzomib + dexamethasone (Kd) for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) (N = 74), were recently published in Blood Cancer Journal by Parmar et al. The primary endpoint of this study was overall response rate (ORR). Secondary endpoints included patient preference of administration method, safety, and pharmacokinetics (PK).

Key data: At a median follow-up of 10.1 months, an ORR of 79.7% was observed with SC isatuximab, and was comparable across OBI and manual injection cohorts. Patient preference analysis (n = 47) favored OBI administration over manual injection (74.5% vs 17%, respectively; p = 0.0004). Adverse events (AEs) leading to full treatment discontinuation were observed in 8.1% of patients. The incidence of infusion reactions was 2.7%, with no infusion reactions occurring with OBI administration. PK was comparable between the two administration methods.

Key learning: SC isatuximab demonstrated comparable outcomes with OBI and manual injection delivery methods, and with previous studies of intravenous (IV) isatuximab in patients with RRMM. The majority of patients preferred OBI administration, supporting its feasibility for isatuximab SC delivery.