Trial Design
SARCLISA Is the First Anti-CD38 Antibody Studied in a Phase 3 Trial in Combination With Pd vs Pd Alone
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.
†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
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)
(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.
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