Novartis data shows Treatment-free Remission rates are consistently above 50% regardless of reason for switch to Tasigna® from Glivec®

Novartis International AG / Novartis data shows Treatment-free Remission rates are consistently above 50% regardless of reason for switch to Tasigna® from Glivec® . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• ENESTop post-hoc analysis provides further insights into Treatment-free Remission (TFR) among Ph+ CML switch patients[1]

• The Tasigna TFR trials, including ENESTop, demonstrate our continued commitment to the CML community

Basel, December 5, 2016 - Novartis today announced at the 58th American Society of Hematology (ASH) 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 (Ph+) chronic myeloid leukemia (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[1],[2]. Results of this post-hoc analysis were presented today in an oral session (ASH Abstract #792).

"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. "CML is considered a chronic disease due to the success of tyrosine kinase inhibitors (TKIs), but there remains a need for continued advancements and these findings are an exciting and important contribution to clinical research in CML treatment."

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[3].