Over 50% of eligible Ph+ CML patients maintain TFR after stopping Tasigna

Swiss pharma giant Novartis (NOVN: VX) has presented the first results from the Tasigna (nilotinib) treatment-free remission (TFR) clinical trial program at the 52nd American Society of Clinical Oncology (ASCO) annual meeting being held in Chicago.

These studies evaluated the potential to maintain molecular response (MR) after stopping therapy in adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase who achieved a sustained deep level of molecular response with Tasigna – a concept called TFR. Findings from two open label Phase II trials, ENESTfreedom and ENESTop, showed that more than 50% of Ph+ CML patients who met the rigorous predefined response criteria of the trials were able to maintain TFR after stopping Tasigna both in the first-line setting and after switching from Gleevec (imatinib mesylate). Discussions with regulatory authorities are underway with potential submissions in 2016.

Results from the ENESTfreedom study found that more than half (51.6%) of 190 CML patients (confidence interval [CI] 95%: 44.2%-58.9%) who achieved a sustained deep molecular response following at least three years of first-line treatment with Tasigna were able to discontinue therapy and remain in TFR for 48 weeks.