Ibrutinib: Interim Phase Ib/II data

Interim data from the open-label, U.S. Phase Ib/II PCYC-1108-CA trial in 30 patients with relapsed or refractory CLL showed that once-daily 420 mg oral PCI-32765 plus bendamustine and rituximab led to an ORR of 90%, with 10% of patients achieving a complete response and 80% achieving a partial response. Additionally, 2 patients achieved a nodal response with residual lymphocytosis. Median follow-up was 4.9 months. Grade 3/4 neutropenia and thrombocytopenia were reported in 47% and 10% of patients, respectively. Grade >3 non-hematologic adverse events that were potentially related to PCI-32765 included rash, fatigue and tumor lysis. Data will be presented at the American Society of Clinical Oncology meeting in June. PCI-32765 has Orphan Drug designation in the U.S. for CLL. Last December, Pharmacyclics partnered with Johnson & Johnson's Janssen Biotech Inc. unit to co-develop and co-commercialize Pharmacyclics' PCI-32765 (see BioCentury, Dec. 12, 2011). ...