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Novartis Tasigna(R) (nilotinib) Trial Shows Superior Results to Glivec(R) (imatinib) in Newly Diagnosed, Chronic Phase Chronic Myeloid Leukaemia
Date:12/8/2009

inib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients (ENESTnd), is a Phase III randomised, open-label, multicentre trial comparing the efficacy and safety of nilotinib versus imatinib in adult patients with newly diagnosed Ph+ CML in the chronic phase.(1) It is the largest global randomised comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients.

ENESTnd is being conducted at 220 global sites, including five sites in the UK, in total 846 patients are enrolled. Patients were randomised to receive nilotinib 400mg twice-daily (n = 281), nilotinib 300mg twice-daily (n = 282) or imatinib 400mg once-daily (n = 283).(1) The primary endpoint was MMR at 12 months; a secondary endpoint was CCyR by 12 months. It is planned that patients are followed up for five years. Patients on the imatinib treatment arm who had suboptimal response or treatment failure will be able to escalate dose and/or switch to nilotinib via a protocol extension.

One of the key effectiveness measures used in the study was called major molecular response (MMR). This is defined as the reduction in levels of the Bcr-Abl protein to less than or equal to 0.1% of the level seen before treatment. MMR is an important measure in CML, as data show that patients who achieve MMR are unlikely to progress to the later stages of the disease.(6) With nilotinib 300mg twice-daily, the rate of MMR at 12 months was twice that of patients receiving imatinib 400mg once-daily (44% vs. 22%, p < 0.0001).(1)

Another effectiveness measure used in the study was called complete cytogenetic response (CCyR). CCyR indicates that no CML cells containing the Ph chromosome can be seen in a sample of bone marrow taken from the patient. 80% of patients achieved CCyR with nilotinib versus 65% with imatinib 400mg once-daily (p < 0.0001).(1) Responses were achieved faster in the nilotinib group than in the imatinib group.(1)

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