Phase III trial success for PCI 32765 (Janssen Biotech) in CLL treatment

Research demonstrates that PCI 32765 (ibrutinib) from Pharmacyclics/Janssen Biotech, may be an effective and safe targeted treatment option for previously untreated, hard-to-treat, and relapsed patients with Chronic Lymphocytic Leukemia (CLL).

A study enrolled 116 CLL patient participants in several treatment cohorts: patients who were never treated (the treatment-naive group), those who had received two or more prior therapies (the relapsed/refractory group), those who had relapsed within two years of treatment (the high-risk group), and those over age 65. Two oral dosing regimens (420 mg or 840 mg daily) of ibrutinib were used. The study found that response to therapy was high across the cohorts, with largely manageable toxicities. Previously untreated elderly patients responded best to the agent, with 71 percent experiencing a complete or partial response at either treatment dose. The same response was observed in 67 percent of the relapsed patients and 50 percent of the high-risk patient cohort.

After 22 months of follow-up, the disease had not progressed in 96 percent of previously untreated patients and 76 percent of relapsed and high-risk patients. Results were presented at the 54th Annual Meeting of the American Society of Hematology.