The new SARCLISA J-code J9227 is now available, effective October 1, 2020, to be used for reimbursement claims. Refer to the Billing and Coding Guide on the Resources page for additional details. MAT-US-2018558-v1.0-08/2020

Trial Design

SARCLISA Is the First Anti-CD38 Antibody Studied in a Phase 3 Trial in Combination With Pd vs Pd Alone

Trial Design Baseline Characteristics

ICARIA-MM: A multicenter, open-label, randomized, phase 3 study1

aPomalidomide 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.

  • SARCLISA 10 mg/kg was administered as an IV infusion weekly in the first cycle and every 2 weeks thereafter
  • Treatment administered in 28-day cycles until disease progression or unacceptable toxicity

Primary endpoint: PFS*

Key secondary endpoints: ORR,† OS

*PFS results were assessed by an IRC, based on central laboratory data for M-protein, and central radiologic imaging review using the IMWG criteria. Median time to follow-up was 11.6 months.
†sCR, CR, VGPR, and PR were evaluated by the IRC using the IMWG response criteria.
Expert review Join Joseph Mikhael, MD, and Kenneth Shain, MD, PhD, as they explore the trial design and patient characteristics for SARCLISA
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The phase 3 ICARIA-MM trial included patients with poor prognostic factors1-3

Treatment history

Patient factors

The phase 3 ICARIA-MM trial included a broad and diverse patient population

Baseline characteristics were similar across treatment arms1-3

 
SARCLISA + Pd
(n=154)
Pd (n=153)
Age
 
 
<65 y
35%
46%
65-74 y
44%
35%
≥75 y
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%
11%
Prior lines of therapy
 
 
Median (range)
3 (2-11)
3 (2-10)
Patient refractory to
 
 
PI
77%
75%
Lenalidomide
94%
92%
IMiD
96%
94%
IMiD + PI
73%
72%
Last regimen
97%
99%
Prior 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.

ASCT=autologous stem cell transplant; COPD=chronic obstructive pulmonary disease; CR=complete response; ECOG PS=Eastern Cooperative Oncology Group performance status; IMiD=immunomodulatory drug; IMWG=International Myeloma Working Group; IRC=independent response committee; IV=intravenous; ORR=overall response rate; OS=overall survival; Pd=pomalidomide and dexamethasone; PFS=progression-free survival; PI=proteasome inhibitor; PR=partial response; R-ISS=Revised International Staging System; sCR=stringent complete response; VGPR=very good partial response.

Back to topTop Trial Results
References: 1. SARCLISA [prescribing information]. Bridgewater, NJ: sanofi-aventis U.S. LLC. 2. Attal M, Richardson PG, Rajkumar SV, et al; on behalf of the ICARIA-MM study group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096-2107. 3. Data on file. sanofi-aventis U.S. LLC.
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