The percentage of patients reporting serious adverse events (SAEs) was higher for ONTAK than for placebo. Drug-related SAEs in ONTAK-treated patients were capillary leak syndrome (4%), dehydration (4%), hypotension (3%), fever (3%), hypoalbuminemia (2%), skin disorder (2%), chest pain (2%), vascular fragility (2%), fatigue (2%), hypersensitivity (2%), myocardial ischemia (1%), urinary tract infection (1%), blood pressure decreased (1%), joint stiffness (1%), myalgia (1%), carpel tunnel syndrome (1%), loss of consciousness (1%), respiratory distress (1%), dermatitis exfoliative (1%), erythema (1%), and rash generalized (1%). The frequency of SAEs decreased after the first two cycles of treatment. The percentage of patients overall who discontinued the study due to an adverse event was higher in the ONTAK group (20.0%) compared with the placebo group (9.1%).
"We are pleased that research continues with ONTAK in the treatment of patients with CTCL," said Judy Jones, Executive Director of the Cutaneous Lymphoma Foundation. "This study reflects Eisai's ongoing commitment to satisfying unmet medical needs in oncology, particularly in CTCL, a form of cancer for which there is no cure."
About ONTAK(R) (denileukin diftitox)
ONTAK is a genetically engineered fusion toxin protein consisting of the amino acid sequences for the enzymatically-active portion of diphtheria toxin fused to the sequence of human interleukin-2, resulting in a molecule that is cytotoxic for cells bearing the target IL-2 receptor expressed on malignant cells.
ONTAK is indicated for the treatment of patients with persistent
or recurrent cutaneous T-cell lymphoma (CTCL) whose malignant cells
express the CD25 component of the IL-2 recepto