ikema : sarclisa + Kd

Subgroup Data for sarclisa + Kd

Consistent PFS results were seen across subgroups with sarclisa + Kd1

  Favors Favors No. of events/total  
Subgroup SARCLISA
+ Kd
Kd SARCLISA
+ Kd
Kd HR (95% CI)
All patients
A forest plot composed of dots within bracketed lines represents the hazard ratio and confidence intervals, respectively, of
the PFS results for each patient subgroup and whether the data favor SARCLISA + Kd or Kd alone. These data are also
represented in the HR (95% CI) column. 46/179 50/123 0.55 (0.37, 0.82)
Age, years
<65 23/88 26/66 0.59 (0.34, 1.04)
≥65 23/91 24/57 0.50 (0.28, 0.89)
Baseline eGFR (MDRD)
≥60 mL/min/1.73 m2 30/122 36/93 0.61 (0.38, 0.99)
<60 mL/min/1.73 m2 10/43 8/18 0.34 (0.13, 0.86)
ISS stage at study entry
I 20/89 22/71 0.64 (0.35, 1.16)
II 16/63 14/31 0.39 (0.19, 0.81)
III 10/26 14/20 0.60 (0.26, 1.34)
Cytogenetic abnormality
Standard risk 27/114 34/77 0.45 (0.27, 0.75)
At least 1 high-risk
cytogenetic abnormalitya
16/42 12/31 0.81 (0.38, 1.72)
del(17p) 5/18 6/16 0.81 (0.25, 2.65)
t(4;14) 10/22 9/20 0.61 (0.25, 1.52)
gain(1q21) 25/75 26/52 0.55 (0.32, 0.95)
Prior lines of therapy
1 18/80 17/55 0.65 (0.33, 1.26)
>1 28/99 33/68 0.48 (0.29, 0.80)
Prior PI in last line
Yes 21/81 17/47 0.62 (0.33, 1.17)
No 25/98 33/76 0.50 (0.30, 0.84)
Prior IMiD® in last line
Yes 21/81 27/62 0.53 (0.30, 0.94)
No 24/98 23/61 0.55 (0.31, 0.97)
Refractory to lenalidomideb
Yes 22/57 23/42 0.61 (0.34, 1.10)
No 24/122 27/81 0.50 (0.29, 0.87)
Previous ASCTb
Yes 32/116 30/69 0.54 (0.33, 0.90)
No 14/63 20/54 0.52 (0.26, 1.03)

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 at least 30% of analyzed plasma cells, except for del(17p), where the threshold was at least 50%.

bLenalidomide-refractory subgroups were not prespecified.

Study limitations

Prespecified subgroup analysis; subgroups were not powered to show differences between treatment arms.

ASCT=autologous stem cell transplant; eGFR=estimated glomerular filtration rate; IMiD=immunomodulatory drug; ISS=International Staging System; Kd=carfilzomib and dexamethasone; MDRD=modification of diet in renal disease; PFS=progression-free survival; PI=proteasome inhibitor.

PFS and rate of ≥VGPR with SARCLISA + Kd in patients with renal impairment*

PFS in patients with renal impairment1

sarclisa + Kd: mPFS NR
Kd: mPFS 19.2 mo
HR=0.34
(95% CI: 0.13, 0.86)

≥VGPR in patients with renal impairment1,2

Study limitations

  • As ORR did not reach statistical significance, CR, VGPR, and PR were not tested for significance

  • Prespecified subgroup analysis; subgroups were not powered to show differences between treatment arms

CR=complete response; mPFS=median progression-free survival; ORR=overall response rate; PR=partial response; VGPR=very good partial response.

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

Older age ≥65 years of age
50%
HR=0.50 (95% CI:0.28, 0.89)
Refractory to lenalidomide
39%
HR=0.61 (95% CI:0.34, 1.10)
Renal impairment
eGFR <60 mL/
min/1.73 m2
66%
HR=0.34 (95% CI:0.13, 0.86)
High cytogenetic risk
19%
HR=0.81 (95% CI:0.38, 1.72)

Study limitations

Prespecified subgroup analysis; subgroups were not powered to show differences between treatment
arms.

*eGFR <60 mL/min/1.73 m2.1

Lenalidomide-refractory subgroups were not prespecified.1

Cytogenetics by central lab; cutoff 50% for del(17p), 30% for t(4;14) and t(14;16).1

Back to topTop