ASH: 6-year data reinforce superiority of nilotinib over imatinib in newly-diagnosed patients with Ph+ CML

Nilotinib (Tasigna) should be considered as a leading option for front-line therapy in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML), according to data presented at the 56^th ASH Annual Meeting and Exposition in San Francisco. 

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NIL Efficacy and Safety in Clinical Trials–Newly Diagnosed Patients (ENESTnd), a phase 3, randomized, open-label, multicenter trial compared the efficacy and safety of nilotinib versus imatinib (Gleevec) in adult patients with newly diagnosed Ph+ CML in chronic phase. It is the largest global randomized comparison of 2 oral therapies ever conducted in newly-diagnosed Ph+ CML patients. The study is being conducted at 217 global sites with 846 patients enrolled.

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“At the ENESTnd 6-year follow up, we’re still seeing consistent evidence that fewer patients on Tasigna vs. Gleevec had their leukemia progress to advanced stage, a key goal of treatment in CML,” according to Giuseppe Saglio, MD, ENEST studies investigator, professor of internal medicine and hematology and director of the department of molecular medicine and targeted therapy, San Luigi University Hospital at the University of Turin, Orbassano, Italy.

“In addition, patients on Tasigna had higher rates of early, deep and sustained molecular response, including MR4.5, a very low level of the protein that causes Ph+ CML,” Dr Saglio said.” ENESTnd also confirmed the favorable risk/benefit profile of Tasigna vs. Gleevec in newly-diagnosed CML patients. Tasigna allows more patients to achieve deep responses earlier, which has been associated with improved long-term outcomes and significantly reduced risk of progression.”

Ph+ CML is a type of cancer of the bone marrow and blood. In people with Ph+ CML, the bone marrow (the soft tissue inside bones where blood cells are made) produces too many white blood cells and these cells are often immature or damaged. 

The study was sponsored by Novartis.