American society of hematology, 52nd annual meeting and exposition.

ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials in Newly Diagnosed Patients) is a global, multicenter, randomized phase 3 study. Conducted at 217 centers in 35 countries, this study is comparing nilotinib (Tasigna, Novartis) with imatinib (Gleevec, Novartis) in patients with newly diagnosed CML–CP. At 24 months, among patients receiving nilotinib 300 mg twice daily (n = 282) and nilotinib 400 mg (n = 281), 74% and 78%, respectively, continued with treatment; 67% of patents in the imatinib 400 mg once-daily group (n = 283) continued with treatment. Discontinuation rates attributed to disease progression were reported to be less than 1% for nilotinib 300 mg twice daily, 1% for nilotinib 400 mg twice daily, and 4% for imatinib 400 mg once daily. Discontinuations for suboptimal response or treatment failure were higher for nilotinib 300 mg twice daily, nilotinib 400 mg twice daily, and imatinib 400 mg once daily, reported at 9%, 2%, and 13% across the respective treatment arms. Death rates were 1% with nilotinib 300 mg twice daily, less than 1% with nilotinib 400 mg twice daily, and 0% for imatinib 400 mg once daily. Between 12 and 24 months, rates of MMRs increased in all treatment groups. At 12 months, significantly higher MMR proportions noted in the nilotinib arms (44%, 43%), compared with imatinib (22%) (P < 0.0001 for both), were sustained at 24 months (62% and 59% with nilotinib vs. 37% with imatinib; P < 0.0001 for both). Fewer than 2% of patients in each treatment arm failed to maintain their MMRs between 12 and 24 months. Comparing kinetics of molecular responses (MRs), Dr. Hughes noted that specific depths of bcr-abl transcript reductions typically occurred 12 months sooner in the nilotinib arms than in the imatinib arm. The percentages of patients achieving 4-log reductions in bcr-abl (complete MRs [CMRs4]) at Dasatinib (Sprycel) Versus Imatinib (Gleevec) In Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia: The DASISION Trial, 18-Month Follow-up • Neil Shah, MD, PhD, University of California, San Francisco School of Medicine, San Francisco, Calif.