ENESTnd, the Phase 3 Trial of TASIGNA in Patients With Newly Diagnosed Ph+ CML
ENESTnd demonstrated superior first-line efficacy of TASIGNA v. imatinib1
ENESTnd is a randomized, controlled, open-label, international, multicenter trial of 846 patients with newly diagnosed Ph+ CML-CP. Patients were randomized to 1 of 2 TASIGNA arms or to imatinib. The primary endpoint was MMR at 12 months.1
The ENESTnd study showed that patients with newly diagnosed Ph+ CML taking TASIGNA achieve earlier and deeper reductions in BCR-ABL and have lower rates of progression than those taking imatinib.1
The ENESTnd Landmark Analysis is a retrospective subgroup analysis (N = 522) of long-term outcomes in patients who did or did not achieve BCR-ABLIS ≤ 10% at 3 months. ENESTnd participants without evaluable PCR samples at 3 months were excluded from the Landmark Analysis.2
BID, twice a day; MMR, major molecular response; Ph+ CML-CP, Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase; QD, once a day.
- TASIGNA® (nilotinib) Summary of Product Characteristics. Basel, Switzerland: Novartis Pharma AG; May 2017.
- Hughes TP, et al. Blood. 2014;123:1353-60.