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Review
. 2025 Jul-Aug;34(7-8):571-589.
doi: 10.1080/13543784.2025.2532446. Epub 2025 Jul 23.

Isatuximab for the treatment of multiple myeloma: current clinical advances and future directions

Affiliations
Free article
Review

Isatuximab for the treatment of multiple myeloma: current clinical advances and future directions

Paul G Richardson et al. Expert Opin Investig Drugs. 2025 Jul-Aug.
Free article

Abstract

Introduction: The addition of the anti-CD38 monoclonal antibody isatuximab to standard therapies is transforming the care of patients with newly diagnosed multiple myeloma (NDMM), as previously seen in the relapsed/refractory setting. This is particularly important for patients with NDMM as early treatment with effective, well tolerated therapies may ensure better clinical outcomes.

Areas covered: Here, we examine recent results from pivotal Phase 3 and 2 clinical trials that demonstrate efficacy and safety of isatuximab across multiple combinations, for both transplant-ineligible and transplant-eligible NDMM patients. We then evaluate long-term outcomes from the IKEMA and ICARIA-MM trials as well as real-world evidence emerging from analyses conducted in patients with relapsed/refractory MM (RRMM). Further, we address current approaches to optimize treatment with isatuximab-based combinations involving changes in bortezomib or dexamethasone dosing. Lastly, we review current findings with new administration modalities developed to optimize delivery of isatuximab in the clinic.

Expert opinion: Supported by multiple lines of high-level evidence, isatuximab in combination with standard-of-care backbone therapies produces triplet or quadruplet regimens with enhanced efficacy and consistent safety for the treatment of patients with NDMM and RRMM.

Keywords: CD38; isatuximab; monoclonal antibody; multiple myeloma; newly diagnosed; relapsed/refractory.

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