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Journal article
Isatuximab plus carfilzomib and dexamethasone in patients with early versus late relapsed multiple myeloma: IKEMA subgroup analysis
Haematologica (Roma), Vol.109(2), pp.604-616
2023
Abstract
Patients with multiple myeloma (MM) who experience early relapse within 12 months of therapy initiation are considered functional high-risk and represent an unmet need, needing better therapies to improve outcomes. The final IKEMA (NCT03275285) progression-free survival (PFS) analysis confirmed the significant PFS improvement reported at interim analysis with isatuximab (Isa) plus carfilzomib and dexamethasone (Kd; Isa-Kd) versus Kd in patients with relapsed MM (updated median PFS: 35.7 vs. 19.2 months; HR=0.58 [95.4% CI: 0.42–0.79]). This IKEMA subgroup analysis examined efficacy and safety of Isa-Kd versus Kd in patients who experienced early (n=61 [Isa-Kd], n=46 [Kd]) versus late relapse (n=104 [Isa-Kd], n=72 [Kd]). As expected, more aggressive features in baseline characteristics were observed in early relapse patients. Consistent with IKEMA overall population results, median PFS (early relapse: 24.7 vs. 17.2 months, HR=0.662 [95% CI: 0.407–1.077]); late relapse: 42.7 vs. 21.9 months, HR=0.542 [95% CI: 0.355–0.826]), minimal residual disease negativity (MRD–) (early relapse: 24.6% vs. 15.2%; late relapse: 37.5% vs. 16.7%), and MRD– complete response (≥CR) rates (early relapse: 18.0% vs. 10.9%; late relapse: 30.8% vs. 13.9%) were higher with Isa-Kd versus Kd, respectively, in both early and late relapse patients. Grade ≥3, serious treatment-emergent adverse events (TEAEs), and death rates were higher in late relapse Isa-Kd arm. However, the numbers of deaths were low and treatment exposure was significantly longer in Isa-Kd versus Kd late relapse patients. These results support the addition of Isa to Kd as standard-of-care therapy for relapsed and/or refractory MM regardless of relapse timing.
Details
- Title
- Isatuximab plus carfilzomib and dexamethasone in patients with early versus late relapsed multiple myeloma: IKEMA subgroup analysis
- Authors/Creators
- Thierry Facon - Université de LillePhilippe MoreauRoss Baker - Murdoch University, Centre for Molecular Medicine and Innovative TherapeuticsChang-Ki Min - Catholic University of KoreaXavier Leleu - InsermMohamad Mohty - Hôpital Saint-AntoineLionel Karlin - Hospices Civils de LyonNicole M. Armstrong - AVEO Oncology (United States)Christina Tekle - AVEO Oncology (United States)Sandrine Schwab - Sanofi (France)Marie-Laure RisseThomas Martin - University of California, San Francisco
- Publication Details
- Haematologica (Roma), Vol.109(2), pp.604-616
- Publisher
- Ferrata Storti Foundation
- Identifiers
- 991005633269907891
- Copyright
- © 2023 T. Facon et al.
- Murdoch Affiliation
- Murdoch University
- Language
- English
- Resource Type
- Journal article
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