ICARIA-MM: SARCLISA + Pd

ICARIA-MM Trial: SARCLISA + Pomalidomide and Dexamethasone (Pd) vs Pd Alone

Evaluated in 307 patients in a phase 3, multicenter, multinational, randomized, open-label study1

Patients with relapsed and/or refractory multiple myeloma who received at least 2 prior therapies, including lenalidomide and a PI (N=307)
Randomized 1:1

sarclisaa + Pdb
(n=154)

Pdb
(n=153)

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.

bPomalidomide 4 mg was taken orally once daily from day 1 to day 21 of each 28-day cycle. Low-dose dexamethasone (orally or IV) 40 mg (20 mg for patients ≥75 years of age) was given on days 1, 8, 15, and 22 for each 28-day cycle.

primary endpoint: PFS*

Key secondary endpoints: ORR, OS

IV=intravenous; ORR=overall response rate; OS=overall survival; PFS=progression-free survival; PI=proteasome inhibitor.

The ICARIA-MM trial included a broad and diverse patient population1-4

Baseline characteristics were balanced across both treatment arms

Patient factors

20%
Elderly (≥75 years)
36%
Impaired renal function
20%
High cytogenetic risk

Treatment history

93%
Refractory to lenalidomide
73%
Refractory to IMiD® + Pl
56%
Prior ASCT
Baseline characteristics
SARCLISA + Pd (n=154)
Pd (n=153)
Age, years
 
 
<65
35%
46%
65-74
44%
35%
≥75
21%
19%
R-ISS stage at study entry
I
25%
20%
II
64%
64%
III
10%
16%
Cytogenetic risk
 
 
Higha
16%
24%
Standard
67%
51%
Missing
18%
26%
Renal function
 
 
<60 mL/min/1.73 m2
39%
34%
History of COPD or asthma at study entry
 
 
Yes
10%
11%
ECOG PS
 
 
0 or 1
90%
90%
2
10%
10%
Prior lines of therapy
 
 
Median (range)
3 (2-11)
3 (2-10)
Patient refractory to
 
 
PI (bortezomib)
77% (62%)
75% (58%)
IMiD (lenalidomide)
96% (94%)
94% (92%)
IMiD + PI
73%
72%
Last regimen
97%
99%
Previous ASCT
 
 
Yes
54%
59%

aOf the patients who had high-risk chromosomal abnormalities at study entry, del(17p), t(4;14), and t(14;16) were present in 12.1%, 8.5%, and 1.6% of patients, respectively. 2

*PFS results were assessed by an IRC, based on central laboratory data for monoclonal protein, and central radiologic imaging review using the IMWG criteria. Median time to follow-up was 11.6 months. 1

Stringent complete response, complete response, very good partial response, and partial response were evaluated by the IRC using the IMWG response criteria. 1

Information on race could not be collected in some countries; hence, not all values were available. The percentage was calculated using N=287 and included 55/142 patients in the SARCLISA + Pd arm and 49/145 patients in the Pd arm. 3

ASCT=autologous stem cell transplant; COPD=chronic obstructive pulmonary disease; ECOG PS=Eastern Cooperative Oncology Group performance status; IMiD=immunomodulatory drug; IMWG=International Myeloma Working Group; IRC=independent response committee; R-ISS=Revised International Staging System.

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