Faculty, Staff and Student Publications

Publication Date

1-1-2025

Journal

Expert Opinion on Investigational Drugs

DOI

10.1080/13543784.2025.2532446

PMID

40657944

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

Humans, Multiple Myeloma, Antineoplastic Combined Chemotherapy Protocols, Antibodies, Monoclonal, Humanized, ADP-ribosyl Cyclase 1, Bortezomib, Dexamethasone, Animals, CD38, isatuximab, monoclonal antibody, multiple myeloma, newly diagnosed, relapsed/refractory

Published Open-Access

yes

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