3), and 4 in
patients with BPDCN (range, 1-43).
Two (2%) patients had fatal adverse reaction, both capillary leak syndrome. Overall, 10 (11%) patientsdiscontinued treatment with ELZONRIS due to an adverse reaction; the most common adverse reactionsresulting in treatment discontinuation were hepatic toxicities and CLS.
Table 3 summarizes the common (≥ 10%) adverse reactions with ELZONRIS in patients with myeloidmalignancies. The rate of any given adverse reaction or lab abnormality was derived from all the reportedevents of that type.
Table 3. Adverse Reactions in ≥ 10% of Patients Receiving 12 mcg/kg of ELZONRIS
N=94
All Grades
%
Grade ≥ 3
%
Vascular disorders
Capillary leak syndrome1 55 9
Hypotension 29 9
Hypertension 15 6
Gastrointestinal disorders
Nausea 49 0
Constipation 23 0
Vomiting 21 0
Diarrhea 20 0
N=94
All Grades
%
Grade ≥ 3
%
General disorders and administration site conditions
Fatigue 45 7
Peripheral edema 43 1
Pyrexia 43 0
Chills 29 1
Investigations
Weight increase 31 0
Nervous system disorders
Headache 29 0
Dizziness 20 0
Metabolism and nutrition disorders
Decreased appetite 24 0
Blood and lymphatic system disorders
Febrile neutropenia 20 18
Musculoskeletal and connective tissue disorders
Back pain 20 2
Pain in extremity 10 2
Respiratory, thoracic and mediastinal disorders
Dyspnea 19 2
Cough 14 0
Epistaxis 14 1
Oropharyngeal pain 12 0
Psychiatric disorders
Insomnia 17 0
Anxiety 15 0
Confusional state 11 0
Cardiac disorders
Tachycardia 17 0
Skin and subcutaneous tissue disorders
Petechiae 10 0
Pruritus 10 0
Renal and urinary disorders
Hematuria 10 0
1 Capillary leak syndrome defined as any event reported as CLS during treatment with ELZONRIS or the occurrence of at least 2 ofthe following CLS manifestations within 7 days of each other: hypoalbuminemia (including albumin value less than 3.0 g/dL), edema(including weight increase of 5 kg or more), hypotension (including systolic blood pressure less than 90 mmHg).
Table 4 summarizes the clinically-important laboratory abnormalities that occurred in ≥ 10% patients withmyeloid malignancies treated with ELZONRIS.
Table 4. Selected Laboratory Abnormalities in Patients Receiving 12 mcg/kg of ELZONRIS
Treatment-Emergent
Laboratory Abnormalities
All Grades
%
Grade ≥ 3
%
Hematology
Platelets decrease 67 53
Hemoglobin decrease 60 35
Neutrophils decrease 37 31
Chemistry
Glucose increase 87 20
ALT increase 82 30
AST increase 79 37
Albumin decrease 77 0
Calcium decrease 57 2
Sodium decrease 50 10
Potassium decrease 39 4
Phosphate decrease 30 11
Creatinine increase 27 0
Alkaline phosphatase increase 26 1
Potassium increase 21 2
Magnesium decrease 20 0
Magnesium increase 14 3
Bilirubin increase 14 0
Glucose decrease 11 0
Sodium increase 10 0
6.2 Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibody formation ishighly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence ofantibo |
