Results from a 5-year follow-up of the phase 3 ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients) study supported the positive benefit-risk profile of nilotinib 300 mg twice daily for the treatment of patients with chronic phase chronic myelogenous leukemia (CML-CP).1

In the trial, nilotinib resulted in earlier and higher response rates and a lower risk of progression to accelerated phase/blast crisis than imatinib in patients with newly diagnosed CML-CP.

Investigators sought to determine the long-term outcomes of ENESTnd. Patients were evaluated at a 5-year follow-up.

Results showed that by 5 years, more than half of all patients in each nilotinib arm (300 mg twice daily, 54%; 400 mg twice daily 52%) had achieved a molecular response compared with 31% of patients in the imatinib arm. Nilotinib’s benefit was observed across all Sokal risk groups.

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Safety results were consistent with previously reported data. More cardiovascular events occurred in patients who received nilotinib than imatinib. Elevations in blood cholesterol and glucose levels also occurred more frequently in the nilotinib group. Given the high rate of mortality associated with CML progression, few deaths in any arm were associated with cardiovascular events, infections, or pulmonary diseases.

Reference

  1. Hochhaus A, Saglio G, Hughes TP, et al. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial [published online ahead of print March 4, 2016]. Leukemia. doi: 10.1038/leu.2016.5.