a (3.8%).
Tables 4 and 5 present the frequency category of adverse reactions and key laboratory abnormalitiesobserved in patients with relapsed or refractory HCL treated with LUMOXITI.
Table 4: Adverse Reactions* in ≥ 20% (All Grades) of Patients with HCL in Study 1053LUMOXITI
N=80
All Grades (%) Grade 3 (%)
General Disorders and Administration Site Conditions
Edema peripheral 39 -
Fatigue 34 -
Pyrexia 31 1.3
Gastrointestinal Disorders
Nausea 35 2.5
Constipation 23 -
Diarrhea 21 -
Injury, Poisoning, and Procedural Complications
Infusion related reactions‡ 50 3.8
Nervous System Disorders
Headache 33 -
Blood and Lymphatic System Disorders
Anemia 21 10 *Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
‡Infusion related reactions: includes patients who were reported to have one or more infusion event that may be infusion-relatedon the day of study drug infusion.
Fluid retention occurred in 63% (50/80) of patients treated with LUMOXITI in Study 1053, includingGrade 3 in 1.3% (1/80) of patients. Fluid retention included all preferred terms of edema peripheral(39%), face edema (14%), abdominal distension (13%), weight increased (8%), pleural effusion (6%),edema (5%), peripheral swelling (5%), localized edema (3.8%), ascites (1.3%), fluid overload (1.3%),fluid retention (1.3%), and pericardial effusion (1.3%). Of the fifty patients with fluid retention, 29% ofpatients required diuretics.
Ocular adverse events occurred, including: blurred vision (9%), dry eye (8%), cataracts (5%), oculardiscomfort and/or pain (4%), ocular swelling/periorbital edema (4%), conjunctivitis (1.3%), conjunctivalhemorrhage (1.3%), and ocular discharge (1.3%).
Table 5: Laboratory Abnormalities* in ≥ 20% (All Grades) Reported in Patients with HCL in Study
1053
LUMOXITI
N=80
All Grades (%) Grade 3 (%) Grade 4 (%)
Hematology
Hemoglobin decreased 43 15 -
Neutrophil count decreased 41 11 20
Platelet count decreased 21 11 3.8
Chemistry
Creatinine increased 96 2.5 -
ALT increased 65 3.8 -
Hypoalbuminemia 64 1.3 -
AST increased 55 1.3 -
Hypocalcemia 54 - -
Hypophosphatemia 53 14 -
LUMOXITI
N=80
All Grades (%) Grade 3 (%) Grade 4 (%)
Hyponatremia 41 8.8 -
Blood Bilirubin increased 30 1.3 -
Hypokalemia 25 1.3 1.3
GGT increased 25 - -
Hypomagnesemia 23 1.3 -
Hyperuricemia 21 - 2.5
Alkaline phosphatase increased 20 - -
ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma glutamyl transferase*
Per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and based onlaboratory measurements worsening from baseline
6.2 Immunogenicity
As with all therapeutic proteins, there is potential for immunogenicity. The detection of antibodyformation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observedincidence of antibody (including neutralizing antibody) positivity in an assay may be influenced byseveral factors, including assay methodology, sample handling, timing of sample collection, concomitantmedications, and underlying disease. For these reasons, comparison of the incidence of antibodies tomoxetumomab pasudotox-tdfk in the studies described below with the incidence of antibodies in otherstudies or to other products may be misleading.
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