ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS

Objective: Phase 3 IKEMA study (NCT03275285) showed significant improvement in PFS with Isatuximab (Isa) + carfilzomib (K) and dexamethasone (d) vs Kd in patients (pts) with relapsed multiple myeloma (MM) (HR: 0.531; 99% CI: 0.32–0.89; P=0.0007), leading to approval of Isa-Kd in US for adults with M...

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Autores principales:	Mehmut TURGUT, Roman HAJEK, Tomas JELÍNEK, Philippe MOREAU, Thomas MARTIN, Ludek POUR, Gabor MIKALA, Argiris SYMEONIDIS, Sara BRINGHEN, Andreea RAWLINGS, Marie Laure RISSE, Helgi VAN DE VELDE, Ivan SPICKA
Formato:	article
Lenguaje:	EN
Publicado:	Elsevier 2021
Materias:	Diseases of the blood and blood-forming organs RC633-647.5
Acceso en línea:	https://doaj.org/article/3c2d6faeced74604914a15ac633f598e
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spelling	oai:doaj.org-article:3c2d6faeced74604914a15ac633f598e2021-11-10T04:32:43ZISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS2531-137910.1016/j.htct.2021.10.975https://doaj.org/article/3c2d6faeced74604914a15ac633f598e2021-11-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2531137921011226https://doaj.org/toc/2531-1379Objective: Phase 3 IKEMA study (NCT03275285) showed significant improvement in PFS with Isatuximab (Isa) + carfilzomib (K) and dexamethasone (d) vs Kd in patients (pts) with relapsed multiple myeloma (MM) (HR: 0.531; 99% CI: 0.32–0.89; P=0.0007), leading to approval of Isa-Kd in US for adults with MM with 1–3 prior lines and in EU for those with ≥1 prior therapy. This post-hoc analysis evaluated efficacy and safety of Isa-Kd vs Kd in relapsed MM pts with pre-existing soft-tissue plasmacytomas (STP). Methodology: Pts (N=302) were randomized (3:2) to Isa-Kd (n=179; 12 had STP) or Kd (n=123; 7 had STP). Doses: Isa: 10 mg/kg IV QW for 4 weeks, then Q2W; K 20 mg/m² days 1–2, then 56 mg/m² twice-weekly 3 of 4 weeks; d: 20 mg twice-weekly. Independent review committee assessed response based on central radiology review and central lab M-protein using International Myeloma Working Group criteria. Median (range) duration of exposure in STP pts (Isa-Kd vs Kd) was 41.9 (2–87) vs 29.9 (4–83) weeks. Results: In STP sub-group, PFS (95% CI) improved in Isa-Kd vs Kd: HR 0.574 (0.125–2.640); median PFS was Isa-Kd: 18.76 months (4.435–not calculable [NC]) vs Kd: NC (0.986–NC). Response rates improved in Isa-Kd vs Kd: overall (50.0% vs 28.6%), ≥VGPR (33.3% vs 14.3%), CR (25.0% vs 0%, all with MRD negativity). TEAE rates (n [%]; Isa-Kd vs Kd) were: Grade ≥3: 12 (100%) vs 4 (57.1%); Grade 5: 2 (16.7%) vs 1 (14.3%); serious: 9 (75.0%) vs 4 (57.1%); discontinuation: 0 (0%) vs 1 (14.3%). Conclusion: Baseline characteristics in STP subgroup were similar to overall ITT population, except ISS stages II, III, and renal function impairment, which were more prevalent in STP subgroup vs ITT. Isa-Kd vs Kd improved PFS and depth of response in pts with relapsed MM and STP, with manageable safety profile, consistent with the benefit observed in IKEMA overall population. Isa-Kd is a new treatment option for pts with relapsed MM and STP.Mehmut TURGUTRoman HAJEKTomas JELÍNEKPhilippe MOREAUThomas MARTINLudek POURGabor MIKALAArgiris SYMEONIDISSara BRINGHENAndreea RAWLINGSMarie Laure RISSEHelgi VAN DE VELDEIvan SPICKAElsevierarticleDiseases of the blood and blood-forming organsRC633-647.5ENHematology, Transfusion and Cell Therapy, Vol 43, Iss , Pp S18- (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Diseases of the blood and blood-forming organs RC633-647.5
spellingShingle	Diseases of the blood and blood-forming organs RC633-647.5 Mehmut TURGUT Roman HAJEK Tomas JELÍNEK Philippe MOREAU Thomas MARTIN Ludek POUR Gabor MIKALA Argiris SYMEONIDIS Sara BRINGHEN Andreea RAWLINGS Marie Laure RISSE Helgi VAN DE VELDE Ivan SPICKA ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS
description	Objective: Phase 3 IKEMA study (NCT03275285) showed significant improvement in PFS with Isatuximab (Isa) + carfilzomib (K) and dexamethasone (d) vs Kd in patients (pts) with relapsed multiple myeloma (MM) (HR: 0.531; 99% CI: 0.32–0.89; P=0.0007), leading to approval of Isa-Kd in US for adults with MM with 1–3 prior lines and in EU for those with ≥1 prior therapy. This post-hoc analysis evaluated efficacy and safety of Isa-Kd vs Kd in relapsed MM pts with pre-existing soft-tissue plasmacytomas (STP). Methodology: Pts (N=302) were randomized (3:2) to Isa-Kd (n=179; 12 had STP) or Kd (n=123; 7 had STP). Doses: Isa: 10 mg/kg IV QW for 4 weeks, then Q2W; K 20 mg/m² days 1–2, then 56 mg/m² twice-weekly 3 of 4 weeks; d: 20 mg twice-weekly. Independent review committee assessed response based on central radiology review and central lab M-protein using International Myeloma Working Group criteria. Median (range) duration of exposure in STP pts (Isa-Kd vs Kd) was 41.9 (2–87) vs 29.9 (4–83) weeks. Results: In STP sub-group, PFS (95% CI) improved in Isa-Kd vs Kd: HR 0.574 (0.125–2.640); median PFS was Isa-Kd: 18.76 months (4.435–not calculable [NC]) vs Kd: NC (0.986–NC). Response rates improved in Isa-Kd vs Kd: overall (50.0% vs 28.6%), ≥VGPR (33.3% vs 14.3%), CR (25.0% vs 0%, all with MRD negativity). TEAE rates (n [%]; Isa-Kd vs Kd) were: Grade ≥3: 12 (100%) vs 4 (57.1%); Grade 5: 2 (16.7%) vs 1 (14.3%); serious: 9 (75.0%) vs 4 (57.1%); discontinuation: 0 (0%) vs 1 (14.3%). Conclusion: Baseline characteristics in STP subgroup were similar to overall ITT population, except ISS stages II, III, and renal function impairment, which were more prevalent in STP subgroup vs ITT. Isa-Kd vs Kd improved PFS and depth of response in pts with relapsed MM and STP, with manageable safety profile, consistent with the benefit observed in IKEMA overall population. Isa-Kd is a new treatment option for pts with relapsed MM and STP.
format	article
author	Mehmut TURGUT Roman HAJEK Tomas JELÍNEK Philippe MOREAU Thomas MARTIN Ludek POUR Gabor MIKALA Argiris SYMEONIDIS Sara BRINGHEN Andreea RAWLINGS Marie Laure RISSE Helgi VAN DE VELDE Ivan SPICKA
author_facet	Mehmut TURGUT Roman HAJEK Tomas JELÍNEK Philippe MOREAU Thomas MARTIN Ludek POUR Gabor MIKALA Argiris SYMEONIDIS Sara BRINGHEN Andreea RAWLINGS Marie Laure RISSE Helgi VAN DE VELDE Ivan SPICKA
author_sort	Mehmut TURGUT
title	ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS
title_short	ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS
title_full	ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS
title_fullStr	ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS
title_full_unstemmed	ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS
title_sort	isatuximab plus carfilzomib and dexamethasone in patients with relapsed multiple myeloma and soft-tissue plasmacytomas: ikema subgroup analysis
publisher	Elsevier
publishDate	2021
url	https://doaj.org/article/3c2d6faeced74604914a15ac633f598e
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ISATUXIMAB PLUS CARFILZOMIB AND DEXAMETHASONE IN PATIENTS WITH RELAPSED MULTIPLE MYELOMA AND SOFT-TISSUE PLASMACYTOMAS: IKEMA SUBGROUP ANALYSIS

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