Isatuximab, carfilzomib, and dexamethasone in patients with relapsed multiple myeloma : updated results from IKEMA, a randomized Phase 3 study
Martin, Thomas (University of California at San Francisco, USA)
Dimopoulos, Meletios (University of Athens, Greece)
Mikhael, Joseph (Translational Genomics Research Institute. City of Hope Cancer Center, Phoenix, USA)
Yong, Kwee (University College Hospital, London, UK)
Capra, Marcelo (Centro Integrado de Hematologia e Oncologia. Hospital Mãe de Deus, Porto Alegre, Brazil)
Facon, Thierry (Lille University Hospital, France)
Hajek, Roman (University of Ostrava, Czech Republic)
Špička, Ivan (Department of Hematology. 1st Faculty of Medicine. Charles University and General Hospital, Prague, Czech Republic)
Baker, Ross (Murdoch University, Perth, Australia)
Kim, Kihyun (Sungkyunkwan University School of Medicine, Seoul, South Korea)
Martinez, Gracia (Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil)
Min, Chang-Ki (The Catholic University of Korea)
Pour, Ludek (University Hospital Brno (República Txeca))
Leleu, Xavier (Service d'Hématologie et Thérapie Cellulaire. CHU and CIC Inserm, France)
Oriol, Albert (Institut Germans Trias i Pujol. Institut de Recerca contra la Leucèmia Josep Carreras)
Koh, Youngil (Seoul National University Hospital, Seoul, South Korea)
Suzuki, Kenshi (Japanese Red Cross Medical Center, Tokyo, Japan)
Casca, France (Ividata Life Science, Levallois-Perret, France)
Macé, Sandrine (Sanofi, R&D, Chilly-Mazarin, France)
Risse, Marie-Laure (Sanofi, R&D, Vitry-sur-Seine, France)
Moreau, Philippe (University Hospital Hôtel-Dieu, Nantes, France)

Date:	2023
Abstract:	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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Published in:	Blood Cancer Journal, Vol. 13 Núm. 1 (december 2023) , ISSN 2044-5385

DOI: 10.1038/s41408-023-00797-8
PMID: 37156782

9 p, 1.5 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP) > Josep Carreras Leukaemia Research Institute
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