BASEL (dpa-AFX) - Novartis announced the new data from the Tasigna or nilotinib ENESTop Treatment-free Remission or TFR study, which demonstrate that TFR rates are consistent among Philadelphia chromosome-positive or Ph+ chronic myeloid leukemia or 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. Results of this post-hoc analysis were presented today in an oral session.
'Findings from this post-hoc analysis of ENESTop suggest that the reason for switching from Glivec to Tasigna did not impact a patient's chance of maintaining TFR,' said Timothy P. Hughes, MD, ENESTop study investigator, Cancer Theme Leader at the South Australian Health and Medical Research Institute and Clinical Professor at the University of Adelaide, Australia.
This new post-hoc analysis of ENESTop evaluated rates of TFR at 48 weeks after stopping treatment with Tasigna among subgroups of patients who switched from Glivec due to intolerance, resistance or physician preference. The analysis, which included 125 patients, found that more than 50% of patients in each of the subgroups maintained TFR at 48 weeks and that the proportion of patients who maintained TFR at 48 weeks was similar across the three subgroups: 30 of 51 (58.8%; 95% confidence interval [CI], 44.2%-72.4%) in the intolerance subgroup, 16 of 30 (53.3%; 95% CI, 34.3%-71.7%) in the resistance subgroup, and 27 of 44 (61.4%; 95% CI, 45.5%-75.6%) in the physician preference subgroup[1]. One patient who stopped treatment in the ENESTop trial was found to have had atypical transcripts and was excluded from this analysis.
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