IKEMA: SARCLISA + Kd
IKEMA Trial Results: SARCLISA + Carfilzomib and Dexamethasone (Kd) vs Kd Alone
SARCLISA + Kd demonstrated superior PFS vs Kd alone
Median PFS with SARCLISA + Kd is not yet reached (NR)1
PFS results are based on a prespecified interim analysis, with a median follow-up time of 20.7 months. PFS results were assessed by an IRC, based on central laboratory data for monoclonal protein, and central radiologic imaging review using the IMWG criteria.
aStratified by the number of previous lines of therapy (1 vs >1) and Revised International Staging System stage (I or II vs III vs not classified) according to interactive response technology.
IMWG=International Myeloma Working Group; IRC=independent response committee; mPFS=median progression-free survival.
The median duration of treatment in the SARCLISA
+ Kd group was 80 weeks
vs 61 weeks for the Kd group1
74% OF PATIENTS IN THE SARCLISA + Kd ARM HAD NOT
vs 59% in the Kd arm at the interim analysis cut-off date2
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend isatuximab-irfc (SARCLISA) for previously treated multiple myeloma2
- In combination with pomalidomide and dexamethasone (Preferred, Category 1)
- In combination with carfilzomib and dexamethasone
NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
NCCN=National Comprehensive Cancer Network.
Patients in the IKEMA trial achieved deep responses*
Response rates across treatment arms1
aStringent complete response, CR, VGPR, and PR were evaluated by the IRC using the IMWG response criteria. Results are based on a prespecified interim analysis with a median follow-up time of 20.7 months. 1
CR=complete response; PR=partial response; VGPR=very good partial response.
As ORR did not reach statistical significance, CR, VGPR, and PR
not tested for significance2
- ORR: SARCLISA + Kd, 87% (95% CI: 0.81, 0.91); Kd, 83% (95% CI: 0.75, 0.89). 95% CI estimated using the Clopper-Pearson method1
- The median time to first response among responders was 1.08 months in the SARCLISA + Kd arm and 1.12 months in the Kd arm2
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*A response of ≥VGPR.