Assessing Treatment-free Remission in adult Ph+ CML-CP patients previously treated with Glivec (imatinib)
ENESTop, evaluated stopping treatment after adult Ph+ CML-CP patients had been treated with Glivec, and then switched to treatment with TASIGNA, and had achieved and sustained deep molecular response for one year with TASIGNA1,2
ENESTop is a single-arm, phase II trial, conducted at 63 sites across 18 countries, assessing treatment-free remission in 163 patients with Ph+ CML-CP who had switched from imatinib to nilotinib. The primary efficacy endpoint was the proportion of patients with successful TFR at 48 weeks, defined as no loss of MMR or confirmed loss of MR4 (2 consecutive RQ-PCR tests) within the first 48 weeks of TFR.1,2
ENESTop is the largest prospective TFR study in patients who switched to TASIGNA from imatinib (n=126 entered the TFR phase).2
a Confirmed loss of MR4.5 defined as BCR-ABL1IS >0.0032%, confirmed in a second assessment within 4 weeks.
b Confirmed loss of MR4 was defined as BCR-ABL1IS >0.01%, confirmed in a second assessment within 4 weeks.
c Patients who did not sustain DMR during the consolidation phase continued to receive TASIGNA. If DMR was reached and sustained, then those patients could enter the TFR-2 phase of the trial (data not yet available for this phase).
CP, chronic phase; DMR, deep molecular response; MMR, major molecular response; MR4, molecular response 4 (4-log reductions); MR4.5, molecular response 4.5 (4.5-log reductions); TFR, treatment-free remission.
- TASIGNA® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; May 2017.
- Hughes TP, et al. ENESTop Study. ASCO; June 3-7, 2016; Chicago, Illinois. Poster 7054.