Ibrutinib: Additional Phase Ib/II data

Data from 31 evaluable treatment-naïve patients aged 65 and older in the open-label, U.S. Phase Ib/II PCYC-1102-CA trial showed that once-daily 420 mg oral PCI-32765 led to an ORR of 81% at a median follow-up of 14.4 months (n=26), with 3 complete responses and 18 partial responses, plus 1 case of stable disease. Once-daily 840 mg PCI-32765 led to an ORR of 40% at a median follow-up of 7.4 months (n=5), with 2 partial responses, plus 1 case of stable disease. Additionally, low-dose PCI-32765 led to a progression-free survival (PFS) rate of 96% at 14.4 months. The once-daily 840 mg cohort was terminated after comparable activity and safety were observed between dose groups in patients with relapsed or refractory disease. The trial enrolled 117 patients, including treatment-naïve patients and patients with relapsed or refractory disease. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...