IKEMA: SARCLISA + CARFILZOMIB
AND DEXAMETHASONE (Kd)
IKEMA Trial: SARCLISA
+ Kd vs Kd Alone
Watch the snapshot summary of how
SARCLISA was studied
See how SARCLISA was studied in two phase 3 trials that included lenalidomide-refractory patients1
Evaluated in 302 patients in a phase 3, multicenter, multinational, randomized, open-label study1,2
sarclisaa + Kdb
(n=179)
Kdb
(n=123)
Treatment was administered in 28-day cycles until disease progression or unacceptable toxicity.
aSARCLISA 10 mg/kg was administered as an IV infusion weekly in the first cycle and every 2 weeks thereafter.
bCarfilzomib was administered as an IV infusion during cycle 1 at a dose of 20 mg/m2 on days 1 and 2, and at 56 mg/m2 on days 8, 9, 15, and 16; during subsequent cycles, it was administered at 56 mg/m2 on days 1, 2, 8, 9, 15, and 16. Dexamethasone (IV on the days of SARCLISA and/or carfilzomib infusions, and orally on the other days) 20 mg was given on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle.
primary endpoint: PFS*
Key secondary endpoints: ORR, ≥VGPR, CR, MRD negativity, OS
The IKEMA trial included a broad and diverse patient population1,2,4
Patient factors
Treatment history
Baseline characteristics were similar across both treatment arms
(n=179)
(n=123)
aImpaired renal function is defined as eGFR <60 mL/min/1.73 m2.1
bHigh-risk cytogenetic status is defined as the presence of del(17p) and/or t(4;14) and/or t(14;16). Chromosomal abnormality was considered positive if present in ≥30% of analyzed plasma cells, except for del(17p), where the threshold is ≥50%.2
c1q21+ was also analyzed and was considered positive if there were ≥3 copies in ≥30% of analyzed plasma cells.2
dInclusion criteria for the IKEMA study specified 1 to 3 prior lines of therapy; however, 3 patients (1.7%) and 2 patients (1.6%) had >3 prior lines in the SARCLISA + Kd and Kd arms, respectively.2
Explore a patient case with high-risk factors who may be
appropriate for SARCLISA + Kd at first relapse1
ASCT=autologous stem cell transplant; ECOG PS=Eastern Cooperative Oncology Group performance status; eGFR=estimated glomerular filtration rate; IMiD=immunomodulatory drug; ISS=International Staging System; PI=proteasome inhibitor.