426 0 Kommentare Novartis Announces Half of Eligible Ph+ CML-CP Patients Remain in Treatment-free Remission (TFR) Nearly Two Years After Stopping Tasigna® (nilotinib)

CAMBERLEY, England, June 23, 2017 /PRNewswire/ --

Tasigna has become the first and only tyrosine kinase inhibitor (TKI) to include information on stopping therapy in Ph+ CML-CP patients in the EU product information
Two clinical trials demonstrate that half of eligible patients were able to maintain TFR after stopping treatment with Tasigna both first-line and after switching from Glivec^[1^],[²^]
More than 90% of Ph+ CML-CP patients in ENESTfreedom and ENESTop who stopped Tasigna were in TFR at 48-weeks remained in TFR at 96-weeks^[1^],[²^]

Novartis today announced new data from two clinical trials, ENESTfreedom and ENESTop, which demonstrate that approximately half of adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia (CML) in the chronic phase (CP), were able to maintain TFR after stopping treatment with Tasigna (nilotinib) both in the first-line setting and after switching from Glivec (imatinib)^[¹^]^,^[²^]. The studies were presented at 22nd Congress of the European Hematology Association (EHA) in Madrid, Spain. Earlier analysis of the two trials at 48 weeks formed the basis for submission to the European Commission (EC), which approved the inclusion of TFR data in the Tasigna Summary of Product Characteristics (SmPC). Tasigna is the first and only tyrosine kinase inhibitor (TKI) to include information on TFR in the European Union (EU) label.

Results from the ENESTfreedom 96-week update found that nearly half of the 190 CML patients (48.9%, confidence interval [CI] 95%: 41.6% - 56.3%) who entered TFR, following at least three years of first-line treatment with Tasigna (and with a sustained deep molecular response (MR4.5) for a year prior to stopping), remained in major molecular response (MMR; BCR-ABL1 International Scale [IS] ≤ 0.1%) and off treatment at week 96, including 88 patients (46.3%) who were in MR4.5^[¹^]. Among patients remaining in TFR for more than 48 weeks (n=100), less adverse events (AEs) were experienced during the second 48 weeks compared to the first 48 week period^[¹^]. Rates of musculoskeletal pain-related AEs were 34% and 9% during first and second 48 week period respectively^[¹^]. These results suggest a reduction in AEs the longer the patient is in TFR.