Depth of response and response kinetics of isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61988987%3A17110%2F22%3AA2302JJV" target="_blank" >RIV/61988987:17110/22:A2302JJV - isvavai.cz</a>

Výsledek na webu

<a href="https://www.webofscience.com/wos/woscc/full-record/WOS:000851364100020" target="_blank" >https://www.webofscience.com/wos/woscc/full-record/WOS:000851364100020</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1182/bloodadvances.2021006713" target="_blank" >10.1182/bloodadvances.2021006713</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Depth of response and response kinetics of isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma

Popis výsledku v původním jazyce

The IKEMA study (Randomized, Open Label, Multicenter Study Assessing the Clinical Benefit of Isatuximab CombinedWith Carfilzomib [Kyprolis((R))] and Dexamethasone Versus CarfilzomibWith Dexamethasone in PatientsWith Relapse and/or Refractory Multiple Myeloma Previously TreatedWith 1 to 3 Prior Lines; #NCT03275285) was a randomized, open-label, multicenter phase 3 study investigating isatuximab plus carfilzomib and dexamethasone (Isa-Kd) vs Kd in patients with relapsedmultiple myeloma. This subanalysis analyzed the depth of response of Isa-Kd vs Kd. The primary end point was progression-free survival (PFS); secondary end points included overall response rate, very good partial response or better (>= VGPR) rate, complete response (CR) rate, and minimal residual disease (MRD) negativity rate (assessed in patients with >= VGPR by next-generation sequencing at a 10(-5) sensitivity level). At amedian follow-up of 20.7 months, deeper responses were observed in the Isa-Kd arm vs the Kd arm, with >= VGPR 72.6% vs 56.1% and CR of 39.7% vs 27.6%, respectively. MRD negativity occurred in 53 (29.6%) of 179 patients in the Isa-Kd arm vs 16 (13.0%) of 123 patients in the Kd arm, with 20.1% (Isa-Kd, 36 of 179 patients) vs 10.6% (Kd, 13 of 123 patients) reachingMRD-negative CR status. Achieving MRD negativity resulted in better PFS in both arms. A positive PFS treatment effect was seen with Isa-Kd in both MRD-negative patients (hazard ratio, 0.578; 95% CI, 0.052-6.405) and MRD-positive patients (hazard ratio, 0.670; 95% CI, 0.452-0.993). Exploratory analysis indicates that both current CR andMRD-negative CR rates are underestimated due toM-protein interference (potential adjusted CR rate, 45.8%; potential adjustedMRD-negative CR rate, 24.0%). In conclusion, there was a clinically meaningful improvement in depth of response with Isa-Kd. The CR rate in Isa-Kd was 39.7%.

Název v anglickém jazyce

Depth of response and response kinetics of isatuximab plus carfilzomib and dexamethasone in relapsed multiple myeloma

Popis výsledku anglicky

The IKEMA study (Randomized, Open Label, Multicenter Study Assessing the Clinical Benefit of Isatuximab CombinedWith Carfilzomib [Kyprolis((R))] and Dexamethasone Versus CarfilzomibWith Dexamethasone in PatientsWith Relapse and/or Refractory Multiple Myeloma Previously TreatedWith 1 to 3 Prior Lines; #NCT03275285) was a randomized, open-label, multicenter phase 3 study investigating isatuximab plus carfilzomib and dexamethasone (Isa-Kd) vs Kd in patients with relapsedmultiple myeloma. This subanalysis analyzed the depth of response of Isa-Kd vs Kd. The primary end point was progression-free survival (PFS); secondary end points included overall response rate, very good partial response or better (>= VGPR) rate, complete response (CR) rate, and minimal residual disease (MRD) negativity rate (assessed in patients with >= VGPR by next-generation sequencing at a 10(-5) sensitivity level). At amedian follow-up of 20.7 months, deeper responses were observed in the Isa-Kd arm vs the Kd arm, with >= VGPR 72.6% vs 56.1% and CR of 39.7% vs 27.6%, respectively. MRD negativity occurred in 53 (29.6%) of 179 patients in the Isa-Kd arm vs 16 (13.0%) of 123 patients in the Kd arm, with 20.1% (Isa-Kd, 36 of 179 patients) vs 10.6% (Kd, 13 of 123 patients) reachingMRD-negative CR status. Achieving MRD negativity resulted in better PFS in both arms. A positive PFS treatment effect was seen with Isa-Kd in both MRD-negative patients (hazard ratio, 0.578; 95% CI, 0.052-6.405) and MRD-positive patients (hazard ratio, 0.670; 95% CI, 0.452-0.993). Exploratory analysis indicates that both current CR andMRD-negative CR rates are underestimated due toM-protein interference (potential adjusted CR rate, 45.8%; potential adjustedMRD-negative CR rate, 24.0%). In conclusion, there was a clinically meaningful improvement in depth of response with Isa-Kd. The CR rate in Isa-Kd was 39.7%.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30205 - Hematology

Projekt

—

Návaznosti

V - Vyzkumna aktivita podporovana z jinych verejnych zdroju

Rok uplatnění

2022

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Blood Advances

ISSN

2473-9529

e-ISSN

—

Svazek periodika

—

Číslo periodika v rámci svazku

15

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

10

Strana od-do

4506-4515

Kód UT WoS článku

000851364100020

EID výsledku v databázi Scopus

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