Phase II data shows PCI 32765 (Pharmacyclics Inc.) provides sustained control in CLL patients

Results from a Phase II trial of PCI 32765 (ibrutinib), from Pharmacyclics Inc., demonstrates the drug offers rapid and sustained control as a monotherapy in untreated, relapsed and refractory Chronic Lymphocytic Leukemia (CLL) patients, irrespective of characteristics that predict poor outcomes to chemoimmunotherapy. It included an analysis of two CLL patient cohorts: the elderly, above 65 years of age, (n=24) and the high risk genetic group with a deletion of chromosome 17p (del 17p) (n=29). After 6 months, 95 percent of patients experienced a reduction in lymph node size and all showed reduction in spleen enlargement, with a median reduction of 55 percent. In 26 patients, tumor infiltration decreased by 82 percent. The Progression Free Survival probability for these patients at 12 months was estimated to be 94 percent.

Most adverse events were mild and manageable and included diarrhea, fatigue and rash, severe events occurred in less than 13 percent of patients. Data was presented by Adrian Wiestner, Hematology Branch, NHLBI, National Institutes of Health, at the American Association for Cancer Research (AACR) annual meeting.