Safety

Safety profile for SARCLISA + Pd

Adverse reactions (≥10%) in patients receiving SARCLISA + Pd with a difference between arms of ≥5% compared with control arm1

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

aPneumonia 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.

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.

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

7% of patients who received SARCLISA discontinued treatment
due to an adverse reaction (grades 1-4)1

Treatment-emergent hematology laboratory abnormalities in patients receiving SARCLISA + Pd vs Pd alone1

Laboratory
parameter
SARCLISA +
Pd (n=152),
n (%)
All grades
All grades
Grade 3
Grade 4
Pd (n=149),
n (%)
All grades
All grades
Grade 3
Grade 4
Anemia
151 (99)
48 (32)
0
145 (97)
41 (28)
0
Neutropenia
146 (96)
37 (24)
92 (61)
137 (92)
57 (38)
46 (31)
Lymphopenia
140 (92)
64 (42)
19 (13)
137 (92)
52 (35)
12 (8)
Thrombocytopenia
127 (84)
22 (14)
25 (16)
118 (79)
14 (9)
22 (15)

Infusion-related reactions1

IRRs: Grade 3-4, 2.6%; All grades, 38%

Onset of IRRs was typically within 24 hours from the start of the infusion. IRRs were reported in 38% of patients treated with SARCLISA.

  • All patients who experienced IRRs experienced them during the first infusion of SARCLISA. IRRs resolved on the same day in 98% of cases
    • 2% of patients also experienced IRRs at their second infusion, and 1.3% experienced IRRs at their fourth infusion
  • Signs and symptoms of grade 3 or higher IRRs included dyspnea, hypertension, and bronchospasm
  • The incidence of infusion interruptions due to IRRs was 29.6%. The median time to infusion interruption was 55 minutes
  • SARCLISA alone was discontinued in 3% of patients due to IRRs
IRRs: Grade 3-4, 2.6%; All grades, 38%

Infections1

  • The incidence of grade 3 or higher infections was 43% in the SARCLISA + Pd group
  • Pneumonia was the most commonly reported severe infection, with grade 3 reported in 22% of patients in the SARCLISA + Pd group compared with 16% in the Pd group, and grade 4 in 3.3% of patients in the SARCLISA + Pd group compared with 2.7% in the Pd group
  • Discontinuations from treatment due to infection were reported in 2.6% of patients in the SARCLISA + Pd group compared with 5.4% in the Pd group
  • Fatal infections were reported in 3.3% of patients in the SARCLISA + Pd group and in 4% in the Pd group

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

Dosing