Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma

Longer-term outcomes with the anti-CD38 antibody isatuximab in combination with carfilzomib-dexamethasone (Isa-Kd) were evaluated in the randomized Phase 3 trial IKEMA (NCT03275285), in a prespecified, follow-up analysis of progression-free survival (PFS, primary study endpoint), final complete resp...

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Detalles Bibliográficos
Autores: Martin, Thomas|||0000-0002-9133-9813, Dimopoulos, Meletios|||0000-0001-8990-3254, Mikhael, Joseph|||0000-0001-9670-2864, Yong, Kwee|||0000-0002-6487-276X, Capra, Marcelo, Facon, Thierry, Hajek, Roman|||0000-0001-6955-6267, Špička, Ivan|||0000-0002-5451-5283, Baker, Ross, Kim, Kihyun, Martinez, Gracia, Min, Chang-Ki, Pour, Ludek, Leleu, Xavier|||0000-0002-9822-4170, Oriol, Albert|||0000-0001-6804-2221, Koh, Youngil, Suzuki, Kenshi, Casca, France, Macé, Sandrine, Risse, Marie-Laure, Moreau, Philippe|||0000-0003-1780-8746
Tipo de recurso: artículo
Fecha de publicación:2023
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:289373
Acceso en línea:https://ddd.uab.cat/record/289373
https://dx.doi.org/urn:doi:10.1038/s41408-023-00797-8
Access Level:acceso abierto
Descripción
Sumario:Longer-term outcomes with the anti-CD38 antibody isatuximab in combination with carfilzomib-dexamethasone (Isa-Kd) were evaluated in the randomized Phase 3 trial IKEMA (NCT03275285), in a prespecified, follow-up analysis of progression-free survival (PFS, primary study endpoint), final complete response (CR) using Hydrashift Isa immunofixation assay, minimal residual disease (MRD) negativity, and safety. Enrolled patients had relapsed/refractory multiple myeloma (1-3 prior treatment lines). Isa 10 mg/kg was administered intravenously weekly in cycle 1 then biweekly. Efficacy analyses were performed in the intent-to-treat population (Isa-Kd: n = 179, Kd: n = 123) and safety evaluated in treated patients (Isa-Kd: n = 177, Kd: n = 122). Consistent with the primary interim analysis, the addition of Isa to Kd prolonged PFS (HR 0.58, 95.4% CI: 0.42-0.79; median PFS 35.7 [95% CI: 25.8-44.0] vs 19.2 [95% CI: 15.8-25.0] months). PFS benefit was observed with Isa-Kd across subgroups, including patients with poor prognosis. The stringent CR/CR rate was 44.1% vs 28.5% (odds-ratio: 2.09, 95% CI: 1.26-3.48), the MRD negativity rate 33.5% vs 15.4% (odds-ratio: 2.78, 95% CI: 1.55-4.99) and the MRD negativity CR rate 26.3% vs 12.2%, with Isa-Kd vs Kd. The safety profile of Isa-Kd was similar to that reported in the prior interim analysis. These findings further support Isa-Kd as a standard-of-care treatment for relapsed multiple myeloma patients.

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