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
min/1.73 m2
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