Two patients discontinued the trial because of adverse events, and six patients required a dose reduction. The most frequently reported adverse events included diarrhea, fatigue, nausea, and ecchymosis (apparent skin bruising). Serious adverse events (SAEs, which are considered relatively common among this immune-compromised patient population) occurred in 38 percent of patients, with 10 percent considered potentially related to treatment. Grade ≥3 severe AEs considered potentially related to treatment occurred in 21 percent of patients. In addition, the majority of patients experienced high lymphocyte count, an event well-documented with this type of treatment, during the first two months of treatment that resolved over time.
"Our results suggest that PC-32765 has the potential to be highly effective and tolerable, and, more importantly, appears to be working well in patients with poor prognoses," said lead author Susan O'Brien, MD, Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center in Houston. "As we become better equipped to target specific cellular functions, it is our hope that therapies like PCI-32765 will become effective interventions to manage disease in patients with CLL."
Dr. O'Brien will present this study in an oral presentation on Tuesday, December 13, at 8:30 a.m. PST at the San Dieg
|Contact: Lindsey Love|
American Society of Hematology