Study of Tasigna (nilotinib) finds treatment-free remission rates consistent in Philadelphia chromosome-positive chronic myeloid leukemia patients- Novartis

Novartis announced at the 58th American Society of Hematology Annual Meeting & Exposition new data from the Tasigna (nilotinib) ENESTop Treatment-free Remission (TFR) study, which demonstrate that TFR rates are consistent among Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) patients who switched from Glivec (imatinib) due to intolerance, resistance or physician preference.

ENESTop evaluated stopping Tasigna treatment in eligible Ph+ CML adults with chronic phase disease after they achieved and sustained deep molecular response (MR) for at least one year with Tasigna but had not achieved and sustained this response previously with Glivec. The analysis, which included 125 patients, found that more than 50% of patients in each of the 3 subgroups maintained TFR at 48 weeks and that the proportion of patients who maintained TFR at 48 weeks was similar across the three subgroups.

In the primary analysis of ENESTop, nearly 6 out of 10 (57.9%) patients who achieved a sustained deep molecular response following at least three years of Tasigna therapy maintained a molecular response 48 weeks after stopping treatment. No new major safety findings were observed in ENESTop in patients treated with Tasigna beyond those in the known safety profile of Tasigna. Results of this post-hoc analysis were presented in an oral session (ASH Abstract #792).