Treatment-free remission (TFR) following nilotinib (NIL) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP): ENESTfreedom, ENESTop, ENESTgoal, and ENESTpath.

Abstract

TPS7124 Background: Approximately 40% of pts who achieve deep, sustained molecular response (MR) on imatinib (IM) are able to successfully maintain TFR (Mahon FX, et al. Lancet Oncol. 2010;11:1029-1035). NIL results in higher rates of deep, sustained MR vs IM and may enable more pts to achieve successful TFR. Four ongoing studies will evaluate the key factors for achieving and sustaining TFR following NIL in pts with CML-CP (Table). Methods: Each study includes a NIL consolidation phase, during which pts undergo frequent molecular monitoring, followed by a TFR phase. In ENESTfreedom and ENESTop, pts with MR4.5 (BCR-ABL ≤ 0.0032% on the international scale [BCR-ABLIS]) on NIL directly enter the 1-y consolidation phase upon enrollment. In ENESTgoal and ENESTpath, pts without deep MR on IM are switched to NIL upon enrollment; after switching to NIL, pts in ENESTgoal who achieve MR4.5 and pts in ENESTpath who complete 2 y of NIL therapy and achieve MR4 (BCR-ABLIS ≤ 0.01%) will be randomized to a 1- or 2-y con...