FINAL ANALYSIS:
44 months median
follow-up

ikema: SARCLISA + carfilzomib
and dexamethasone
(Kd)

Subgroup Data for sarclisa + Kd

Consistent PFS results were seen across almost all subgroups with sarclisa + Kd1

  Favors Favors No. of events/total  
Subgroup SARCLISA
+ Kd
Kd SARCLISA
+ Kd
Kd HR (95% CI)
All patients
78/179 68/123 0.59 (0.42, 0.83)
Age, years
<65 37/88 37/66 0.57 (0.36, 0.90)
≥65 41/91 31/57 0.59 (0.37, 0.95)
Renal impairment
<60 mL/min/1.73 m2 22/43 8/18 0.67 (0.30, 1.51)
≥60 mL/min/1.73 m2 49/122 54/93 0.56 (0.38, 0.82)
ISS stage at study entry
I 35/89 38/71 0.55 (0.35, 0.87)
II 31/63 15/31 0.63 (0.34, 1.18)
III 12/26 15/20 0.61 (0.28, 1.31)
Cytogenetic abnormality
Standard risk 48/114 45/77 0.53 (0.35, 0.80)
At least 1 high-risk
cytogenetic abnormalitya
25/42 16/31 0.86 (0.46, 1.61)
del(17p) 9/18 9/16 0.79 (0.31, 2.00)
t(4;14) 15/22 11/20 0.77 (0.35, 1.69)
1q21+b 37/75 31/52 0.62 (0.38, 1.01)
Prior lines of therapy
1 40/80 27/55 0.79 (0.48, 1.29)
>1 38/99 41/68 0.45 (0.29, 0.71)
Previous treatment with bortezomib
Yes 73/163 60/102 0.56 (0.39, 0.79)
No 5/16 8/21 0.52 (0.17, 1.60)
Prior IMiD in last line
Yes 35/81 34/62 0.58 (0.36, 0.94)
No 43/98 34/61 0.58 (0.37, 0.91)
Refractory to lenalidomide
Yes 28/57 28/42 0.57 (0.34, 0.97)
No 50/122 40/81 0.60 (0.40, 0.91)
Previous ASCT
Yes 51/116 40/69 0.57 (0.37, 0.86)
No 27/63 28/54 0.60 (0.35, 1.02)

0.0 0.5 1.0 1.5 2.0

aHigh-risk cytogenetic status was 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 was ≥50%; please note that due to the low number of patients with t(14;16), the HR could not be calculated.1

b1q21+ was also analyzed and was considered positive if there were ≥3 copies in ≥30% of analyzed plasma cells.1

Study limitations

All subgroups were prespecified except the lenalidomide-refractory subgroup. Subgroups were not powered to show differences between treatment arms.

ASCT=autologous stem cell transplant; IMiD=immunomodulatory drug; ISS=International Staging System; PFS=progression-free survival.

Reduction in the risk of disease progression in patients treated with SARCLISA + Kd vs Kd alone1

Older age ≥65 years of age
41%
HR=0.59 (95% CI: 0.37, 0.95)
Refractory to lenalidomide
43%
HR=0.57 (95% CI: 0.34, 0.97)
Renal impairment
eGFR <60 mL/
min/1.73 m2
33%
HR=0.67 (95% CI: 0.30, 1.51)
Presence of 1q21+*
38%
HR=0.62 (95% CI: 0.38, 1.01)

Study limitations

All subgroups were prespecified except the lenalidomide-refractory subgroup. Subgroups were not powered to show differences between treatment arms.

*1q21+ was considered positive if there were ≥3 copies in ≥30% of analyzed plasma cells.1

Explore a patient case with high-risk factors who may
be appropriate for sarclisa + Kd at first relapse2

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