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Prashant Kapoor, MD, FACP


Long-Terms Results With Isatuximab-Based Regimen for 1q21-Positive Patients With Myeloma

By: Celeste L. Dixon
Posted: Tuesday, July 25, 2023

The monoclonal antibody isatuximab in combination with carfilzomib and dexamethasone continues to show greater progression-free survival benefit and deeper responses than carfilzomib and dexamethasone alone in patients who have a 1q21 chromosomal abnormality, with or without additional high-risk chromosomal abnormalities, and relapsed multiple myeloma, according to results of a long-term subgroup follow-up analysis of the phase III IKEMA study. These results were consistent with analyses of the overall population and with earlier interim analyses of the subgroup with an 1q21 abnormality, according to Thierry Facon, MD, of Lille University Hospital, France, and colleagues, who presented their findings at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 8029).

After a median follow-up of 44.2 months, patients with one to three prior lines of therapy were randomly assigned to the triplet therapy (n = 179) or the doublet control (n = 123). Using fluorescence in situ hybridization, 1q21 abnormality status was defined as “at least three copies, gain of chromosome 1q21 as three copies, and amplification of chromosome 1q21 as at least four copies.”

“Greater progression-free survival benefit was achieved with isatuximab, carfilzomib, and dexamethasone versus carfilzomib and dexamethasone alone in patients with 1q21-positive status (hazard ratio = 0.58),” noted Dr. Facon and co-investigators. In terms of deepened response with isatuximab, it induced “increased rates of very good partial response or better, complete response or better, [measurable] residual disease [MRD] negativity, and MRD negativity with complete response or better.”

In the isatuximab and control arms, 41.9% and 42.3% of patients had 1q21-positive status: 26.3% and 25.2% with isolated 1q21 positivity, 24.0% and 30.1% with gain of chromosome 1q21, and 17.9% and 12.2% with amplification of chromosome 1q21, respectively. Gain or amplification of chromosome 1q21 negatively impacted prognosis in multiple myeloma because of its potential involvement in resistance to disease-specific therapy and disease progression, according to the investigators.

Disclosure: The study authors’ disclosure information can be found at

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