Ibrutinib: Additional Phase II data

Additional data from 110 evaluable patients with relapsed or refractory MCL in the open-label, international Phase II PCYC-1104-CA trial showed that once-daily 560 mg oral ibrutinib led to an estimated median duration of response of 17.5 months. Median OS has not yet been reached, but the estimated 18-month OS rate was 58%. Data were presented at the European Hematology Association meeting in Stockholm. Pharmacyclics previously reported that ibrutinib led to an ORR of 68%, including a 22% complete response rate and a 46% partial response rate. Median PFS was 13.9 months (see BioCentury, Dec. 19, 2011 & Dec. 17, 2012). Ibrutinib is in Phase III testing for MCL and Pharmacyclics expects to submit an NDA to FDA for the product in the indication by year end. ...