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

Thomas Martin; Meletios-Athanasios Dimopoulos; Joseph Mikhael; Kwee Yong; Marcelo Capra; Thierry Facon; Roman Hajek; Ivan Špička; Ross Baker; Kihyun Kim; Gracia Martinez; Chang-Ki Min; Ludek Pour; Xavier Leleu; Albert Oriol; Youngil Koh; Kenshi Suzuki; France Casca; Sandrine Macé; Marie-Laure Risse; Philippe Moreau

doi:10.1038/s41408-023-00797-8

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

Journal article

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

Thomas Martin, Meletios-Athanasios Dimopoulos, Joseph Mikhael, Kwee Yong, Marcelo Capra, Thierry Facon, Roman Hajek, Ivan Špička, Ross Baker, Kihyun Kim, …

Blood cancer journal (New York), Vol.13(1), 72

2023

DOI: https://doi.org/10.1038/s41408-023-00797-8

PMID: 37156782

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Abstract

Antibodies, Monoclonal, Humanized - therapeutic use

Antineoplastic Combined Chemotherapy Protocols - adverse effects

Dexamethasone

Humans

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 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.

Details

Title: Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma: updated results from IKEMA, a randomized Phase 3 study
Authors/Creators: Thomas Martin - Department of Hematology, University of California at San Francisco, San Francisco, CA, USA. Tom.Martin@ucsf.edu
Meletios-Athanasios Dimopoulos - The National and Kapodistrian University of Athens, Athens, Greece
Joseph Mikhael - Translational Genomics Research Institute, City of Hope Cancer Center, Phoenix, AZ, USA
Kwee Yong - Department of Haematology, University College Hospital, London, UK
Marcelo Capra - Centro Integrado de Hematologia e Oncologia, Hospital Mãe de Deus, Porto Alegre, Brazil
Thierry Facon - Department of Haematology, Lille University Hospital, Lille, France
Roman Hajek - Department of Hemato-Oncology, University Hospital Ostrava and Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic
Ivan Špička - Department of Hematology, 1st Faculty of Medicine, Charles University and General Hospital, Prague, Czech Republic
Ross Baker - Murdoch University, Centre for Molecular Medicine and Innovative Therapeutics
Kihyun Kim - Sungkyunkwan University
Gracia Martinez - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Chang-Ki Min - Catholic University of Korea
Ludek Pour - Department of Internal Medicine, Hematology and Oncology, University Hospital Brno, Brno, Czech Republic
Xavier Leleu - Service d'Hématologie et Thérapie Cellulaire, CHU and CIC Inserm, 1402, Poitiers Cedex, France
Albert Oriol - Institut Josep Carreras and Institut Catala d'Oncologia, Hospital Germans Trias I Pujol, Badalona, Spain
Youngil Koh - Seoul National University Hospital
Kenshi Suzuki - Japanese Red Cross Medical Center
France Casca - Ividata Life Science, Levallois-Perret, France
Sandrine Macé - Sanofi, R&D, Chilly-Mazarin, France
Marie-Laure Risse - Sanofi, R&D, Vitry-sur-Seine, France
Philippe Moreau - Department of Hematology, University Hospital Hôtel-Dieu, Nantes, France
Publication Details: Blood cancer journal (New York), Vol.13(1), 72
Publisher: Springer Nature
Identifiers: 991005581068807891
Murdoch Affiliation: Murdoch University
Language: English
Resource Type: Journal article

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Collaboration types: Industry collaboration; Domestic collaboration; International collaboration
Citation topics: 1 Clinical & Life Sciences; 1.130 Lymphomas; 1.130.617 Multiple Myeloma
Web Of Science research areas: Hematology; Oncology
ESI research areas: Clinical Medicine