ENESTnd 5-year (y) update: Long-term outcomes of patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) treated with frontline nilotinib (NIL) versus imatinib (IM).

7073 Background: In ENESTnd, NIL has shown superior efficacy vs IM. Here, we report data based on a minimum follow-up of 5 calendar y. Methods: Pts with newly diagnosed CML-CP were randomized to NIL 300 mg twice-daily (BID; n = 282), NIL 400 mg BID (n = 281), or IM 400 mg once-daily (QD; n = 283). P values for secondary efficacy endpoints were not adjusted for multiple comparisons and are provided for descriptive purposes only. Results: At the data cutoff, 60%, 62%, and 50% of pts in the NIL 300 mg BID, NIL 400 mg BID, and IM arms, respectively, remained on core treatment. Over half of pts in the NIL arms achieved MR4.5 (BCR-ABLIS ≤ 0.0032%) by 5 y, and MR4.5 rates were significantly higher on NIL vs IM overall and within each Sokal risk group (Table). Rates of major molecular response (MMR; BCR-ABLIS ≤ 0.1%), freedom from progression to accelerated phase/blast crisis (AP/BC), and overall survival (OS) were higher on NIL vs IM. Fewer pts treated with NIL vs IM died from advanced CML. The safety profiles o...