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.

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

Gay, Francesca;
2025-01-01

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.
2025
34
7-8
571
589
CD38; isatuximab; monoclonal antibody; multiple myeloma; newly diagnosed; relapsed/refractory
Richardson, Paul G; O'Donnell, Elisabeth K; O'Gorman, Peter; Leypoldt, Lisa B; Laubach, Jacob; Gay, Francesca; Leleu, Xavier; Facon, Thierry; Moreau, ...espandi
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/2122627
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