Nilotinib Meets Primary Endpoint in Pivotal Trial Against Imatinib as First-Line Treatment in Chronic Myeloid Leukemia Patients

Novartis announced recently that nilotinib (Tasigna) 200-mg capsules met its primary endpoint in the first head-to-head comparison with the company’s groundbreaking drug imatinib mesylate (Gleevec) tablets. Nilotinib produced faster and deeper responses than imatinib when given as first-line therapy for adult patients with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Nilotinib was well tolerated in the study.

The phase III clinical trial, Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients (ENESTnd), is the largest global randomized comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients. Designed to detect a difference in major molecular response between nilotinib and imatinib after 12 months of treatment, it is also the first registration study in which molecular traces of a key biomarker specific to Ph+ CML have been used as a primary endpoint for regulatory review. The study also met its secondary endpoint, a difference in complete cytogenetic response in favor of nilotinib.

Details of the ENESTnd findings will be submitted as a late-breaking abstract to the 51st annual meeting of the American Society of Hematology, to take place in December in New Orleans.