Tasigna nilotinib: Additional Phase III data

Additional data from the open-label, international Phase III ENESTnd trial in 846 patients showed that 300 and 400 mg twice-daily Tasigna achieved significantly higher MMR rates at 18 months vs. 400 mg once-daily imatinib (44% and 43%, respectively, vs. 22%, p<0.0001 for each). At 18 months, CCyR rates also were significantly higher with 300 and 400 mg Tasigna vs. 400 mg imatinib (85% and 82%, respectively, vs. 74%, p<0.0001 for each). Progression to advanced diseases was observed in 2 patients receiving 300 mg Tasigna and 1 patient receiving 400 mg Tasigna compared with 12 patients receiving 400 mg imatinib. Also at 18 months, the data showed that there were 3 CML-related deaths in the Tasigna arms vs. 12 CML-related deaths in the Gleevec arm.

The company previously reported that Tasigna met the primary endpoint of a significantly higher MMR rate at 12 months vs. Gleevec (see BioCentury, Oct. 26, 2009, & Dec. 14, 2009). Data were presented at the American Society of Clinical Oncology meeting in Chicago. The company plans to conduct a 5-year follow-up of patients in the trial. ...