ICARIA-MM: SARCLISA + POMALIDOMIDE AND DEXAMETHASONE (Pd)

Subgroup Data for SARCLISA + Pd

PFS Subgroup Analysis Renal Impairment PFS Subgroup Highlights

Consistent PFS results were seen across subgroups with
SARCLISA + Pd1-3

  Favors Favors No. of events/total  
Subgroup SARCLISA
+ Pd		 Pd SARCLISA
+ Pd		 Pd HR (95% CI)
All patients
73/154 89/153 0.60 (0.44, 0.81)
Age, years
<65 26/54 41/70 0.66 (0.40, 1.07)
65-74 32/68 29/54 0.64 (0.39, 1.06)
≥75 15/32 19/29 0.48 (0.24, 0.95)
R-ISS stage at study entry
I 13/39 17/31 0.58 (0.28, 1.21)
II 47/99 57/98 0.59 (0.40, 0.87)
III 13/16 15/24 0.61 (0.28, 1.31)
Cytogenetic abnormalitya
Standard 50/103 48/78 0.62 (0.42, 0.93)
At least 1 high-risk
cytogenetic abnormality		 14/24 22/36 0.66 (0.33, 1.28)
del(17p) 7/14 13/23 0.76 (0.30, 1.92)
t(4;14) 8/12 9/14 0.49 (0.19, 1.31)
gain(1q21) 41/76 37/52 0.40 (0.25, 0.63)
Renal impairment
<60 mL/min/1.73 m2 30/55 29/49 0.50 (0.30, 0.85)
≥60 mL/min/1.73 m2 36/87 55/96 0.58 (0.38, 0.88)
Previous lines of therapy
2-3 44/102 57/101 0.59 (0.40, 0.88)
>3 29/52 32/52 0.59 (0.36, 0.98)
Refractory to a Pl
Yes 57/118 67/115 0.58 (0.41, 0.82)
No 16/36 22/38 0.67 (0.35, 1.28)
Refractory to lenalidomide
Yes 72/144 82/140 0.59 (0.43, 0.82)
No 1/10 7/13 0.18 (0.02, 1.49)
Refractory to lenalidomide and a Pl
Yes 56/111 62/107 0.58 (0.40, 0.84)
No 17/43 27/46 0.60 (0.33, 1.11)
Previous ASCT
Yes 40/83 55/90 0.60 (0.40, 0.90)
No 33/71 34/63 0.62 (0.38, 1.00)

aCytogenetic risk information was missing for 18% of patients in the SARCLISA + Pd arm and 26% of patients in the Pd arm. Of the patients who had high-risk chromosomal abnormalities at study entry, del(17p), t(4;14), and t(14;16) were present in 12%, 8%, and 2% of patients, respectively. High-risk cytogenetic status was defined by the presence of ≥1 of del(17p), t(4;14), or t(14;16), and was considered positive if present in ≥30% of plasma cells for t(4;14) and t(14;16), and in ≥50% of plasma cells for del(17p). Gain(1q21) was considered positive if ≥3 copies of 1q21 were present in ≥30% of analyzed cells.1,3,4

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

PFS and ORR in the intent-to-treat population4

  • mPFS: 11.53 months with SARCLISA + Pd (n=154) vs 6.47 months with Pd alone (n=153), HR=0.596 (95% CI: 0.44, 0.81; P=0.0010)

  • ORR: SARCLISA + Pd, 60.4% (95% CI: 0.52, 0.68); Pd, 35.3% (95% CI: 0.28, 0.43)

ASCT=autologous stem cell transplant; mPFS=median progression-free survival; ORR=overall response rate; PFS=progression-free survival; PI=proteasome inhibitor; R-ISS=Revised International Staging System.

PFS and ORR with SARCLISA + Pd in patients with renal impairment*

PFS in patients with renal impairment5

A Kaplan-Meier curve compares the median progression-free survival (mPFS) of patients with renal impairment receiving SARCLISA + Pd (mPFS 9.5 months) vs Pd alone (mPFS 3.7 months); HR=0.50 (95% CI: 0.30, 0.85).

Response rates in patients with renal impairment5

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

*eGFR <60 mL/min/1.73 m2.4

CR=complete response; eGFR=estimated glomerular filtration rate; PR=partial response; VGPR=very good partial response.

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

Elderly ≥75 years of age
52%
HR=0.48 (95% CI: 0.24, 0.95)
Refractory to lenalidomide
41%
HR=0.59 (95% CI: 0.43, 0.82)
Renal impairment
eGFR <60 mL/
min/1.73 m2
50%
HR=0.50 (95% CI: 0.30, 0.85)
High cytogenetic risk†
34%
HR=0.66 (95% CI: 0.33, 1.28)

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

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

Learn about patient types that may be right for treatment
with
sarclisa + Pd

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ICARIA-MM Safety
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