ICARIA-MM: SARCLISA + Pd

Adverse Reactions for SARCLISA + Pd

Discontinuation rates

Permanent treatment discontinuation due to adverse reactions (grades 1 to 4)

SARCLISA + Pd
Pd
7%
12%
  • Dosage interruptions due to an adverse reaction occurred in 31% of patients who received SARCLISA + Pd1
    • Discontinuations from treatment due to infection were reported in 2.6% of patients receiving SARCLISA + Pd vs 5.4% of patients receiving Pd alone
    • The most frequent adverse reaction requiring dosage interruption was IRR (28%)

The addition of SARCLISA to Pddid not increase treatment discontinuations due to adverse reactions vs Pd alone1,2

Adverse reactions (≥10%) in patients receiving SARCLISA + Pd with a difference between arms of ≥5% compared with Pd alone1

Adverse reactions
SARCLISA + Pd
(n=152)
All grades
All grades
Grade 3
Grade 4
Pd (n=149)
All grades
All grades
Grade 3
Grade 4
General disorders and administration site conditions
IRRa
38%
1.3%
1.3%
0%
0%
0%
Infections
Upper respiratory tract infectionb
57%
9%
0%
42%
3.4%
0%
Pneumoniac
31%
22%
3.3%
23%
16%
2.7%
Blood and lymphatic system disorders
Febrile neutropenia
12%
11%
1.3%
2%
1.3%
0.7%
Respiratory, thoracic, and mediastinal disorders
Dyspnead
17%
5%
0%
12%
1.3%
0%
Gastrointestinal disorders
Diarrhea
26%
2%
0%
19%
0.7%
0%
Nausea
15%
0%
0%
9%
0%
0%
Vomiting
12%
1.3%
0%
3.4%
0%
0%

aIRR includes IRR, cytokine release syndrome, and drug hypersensitivity.

bUpper respiratory tract infection includes bronchiolitis, bronchitis, bronchitis viral, chronic sinusitis, fungal pharyngitis, influenza-like illness, laryngitis, nasopharyngitis, parainfluenzae virus infection, pharyngitis, respiratory tract infection, respiratory tract infection viral, rhinitis, sinusitis, tracheitis, upper respiratory tract infection, and upper respiratory tract infection bacterial.

cPneumonia includes atypical pneumonia, bronchopulmonary aspergillosis, pneumonia, pneumonia haemophilus, pneumonia influenzal, pneumonia pneumococcal, pneumonia streptococcal, pneumonia viral, candida pneumonia, pneumonia bacterial, haemophilus infection, lung infection, pneumonia fungal, and Pneumocystis jirovecii pneumonia.

dDyspnea includes dyspnea, dyspnea exertional, and dyspnea at rest.

IRR=infusion-related reaction; Pd=pomalidomide and dexamethasone.

See the types of IRRs that occurred in the ICARIA-MM trial and how to manage them

Serious adverse reactions1,2

  • Serious adverse reactions occurred in 62% of patients receiving SARCLISA + Pd
    • Serious adverse reactions in >5% of patients who received SARCLISA + Pd included pneumonia (26%), upper respiratory tract infection (7%), and febrile neutropenia (7%)
  • Fatal adverse reactions occurred in 11% of patients in the SARCLISA + Pd arm (those that occurred in >1% of patients were pneumonia and other infections [3%]) vs 11% in the Pd arm
Laboratory
parameter
SARCLISA + Pd
(n=152)
All grades
All grades
Grade 3
Grade 4
Pd (n=149)
All grades
All grades
Grade 3
Grade 4
Hemoglobin decreased
99%
32%
0%
97%
28%
0%
Neutrophils decreased
96%
24%
61%
92%
38%
31%
Lymphocytes decreased
92%
42%
13%
92%
35%
8%
Platelets decreased
84%
14%
16%
79%
9%
15%
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