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Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study

T. Martin, MA. Dimopoulos, J. Mikhael, K. Yong, M. Capra, T. Facon, R. Hajek, I. Špička, R. Baker, K. Kim, G. Martinez, CK. Min, L. Pour, X. Leleu, A. Oriol, Y. Koh, K. Suzuki, F. Casca, S. Macé, ML. Risse, P. Moreau

. 2023 ; 13 (1) : 72. [pub] 20230509

Language English Country United States

Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc23011464

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.Clinical trial information: ClinicalTrials.gov, NCT03275285.

Centro Integrado de Hematologia e Oncologia Hospital Mãe de Deus Porto Alegre Brazil

Department of Haematology Lille University Hospital Lille France

Department of Haematology University College Hospital London UK

Department of Hemato Oncology University Hospital Ostrava and Faculty of Medicine University of Ostrava Ostrava Czech Republic

Department of Hematology 1st Faculty of Medicine Charles University and General Hospital Prague Czech Republic

Department of Hematology Seoul St Mary's Hospital The Catholic University of Korea Seoul South Korea

Department of Hematology University Hospital Hôtel Dieu Nantes France

Department of Hematology University of California at San Francisco San Francisco CA USA

Department of Internal Medicine Hematology and Oncology University Hospital Brno Brno Czech Republic

Department of Internal Medicine Seoul National University Hospital Seoul South Korea

Division of Hematology Oncology Department of Medicine Samsung Medical Center Sungkyunkwan University School of Medicine Seoul South Korea

Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo São Paulo Brazil

Institut Josep Carreras and Institut Catala d'Oncologia Hospital Germans Trias 1 Pujol Badalona Spain

Ividata Life Science Levallois Perret France

Myeloma Amyloidosis Center Japanese Red Cross Medical Center Tokyo Japan

Perth Blood Institute Murdoch University Perth Australia

Sanofi R and D Chilly Mazarin France

Sanofi R and D Vitry sur Seine France

Service d'Hématologie et Thérapie Cellulaire CHU and CIC Inserm 1402 Poitiers Cedex France

The National and Kapodistrian University of Athens Athens Greece

Translational Genomics Research Institute City of Hope Cancer Center Phoenix AZ USA

References provided by Crossref.org

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$a 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.Clinical trial information: ClinicalTrials.gov, NCT03275285.
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