Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia

SUMMARY: ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients) is a phase III, randomized, open-label, multicenter study comparing the efficacy and safety of Nilotinib (TASIGNA®), either 300 mg or 400 mg bid with GLEEVEC® (Imatinib) 400mg qd, in patients with newly diagnosed Ph+ CML in chronic phase. Of the 846 patients enrolled, 282 patients received TASIGNA® 300 mg bid, 281 patients received TASIGNA® 400 mg bid and 283 patients received GLEEVEC® 400 mg qd. With a median follow up of 18 months, the MMR (Major Molecular Response) was 66% for the TASIGNA® 300 mg bid group and 62% for the TASIGNA® 400 mg bid group compared with 40% for the GLEEVEC® 400 mg qd group. The median time to MMR amongst the patients who achieved MMR was faster for TASIGNA® 300 mg bid (5.7 months) and TASIGNA® 400 mg bid (5.8 months) groups of patients compared with GLEEVEC® 400 mg qd (8.3 months). The rates of complete cytogenetic response at 18 months were also significantly higher for both TASIGNA® groups – 85% in the TASIGNA® 300 mg bid group, 82% in the TASIGNA® 400 mg bid group and 74% in the GLEEVEC® 400 mg qd group. Fewer patients in the TASIGNA® groups progressed to accelerated phase or blast crises compared with GLEEVEC® group. Adverse effects more often seen with TASIGNA® included skin rash, headache, liver function abnormalities, high cholesterol, hyperglycemia, increased serum lipase, abnormal electrolyte levels and prolongation of the QT interval. The authors concluded that TASIGNA® at both 300 mg bid and 400 mg bid induced significantly higher and faster rates of MMR and complete cytogenetic remission compared with GLEEVEC® 400 mg qd. J Clin Oncol 28:15s, 2010 (suppl; abstr 6501)