Study 1053: Adverse Reactionsa in ≥20% (All Grades) of Patients with HCL (N=80)1

aPer National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.

bInfusion-related reactions: include patients who were reported to have one or more infusion event that may be infusion-related on the day of study drug infusion.

Adverse Reactions: Clinical Trials Experience

Fluid retention occurred in 63% (50/80) of patients treated with LUMOXITI in Study 1053, including Grade 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% of patients required diuretics.

Ocular adverse events occurred, including: blurred vision (9%), dry eye (8%), cataracts (5%), ocular discomfort and/or pain (4%), ocular swelling/periorbital edema (4%), conjunctivitis (1.3%), conjunctival hemorrhage (1.3%), and ocular discharge (1.3%).1

Study 1053: Laboratory Abnormalitiesc in ≥20% (All Grades) Reported in Patients with HCL (N=80)1

ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma glutamyl transferase.

cPer National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 and based on laboratory measurements worsening from baseline.

15% of patients in Study 1053 discontinued due to drug-related adverse reactions1

  • The most common adverse reaction leading to LUMOXITI discontinuation was hemolytic uremic syndrome (HUS) (5%)1
  • The most common adverse reaction resulting in dose delays, omissions, or interruptions was pyrexia (3.8%)1

Median CD3+, CD4+, and CD8+ T cells, and CD16+/CD56 Natural Killer cells were reduced from baseline on Day 8, and returned to normal or were elevated above baseline levels on Day 29 and thereafter 1