(Pr)Tasigna surpassed gold standard in all designated measures of efficacy, including prevention of disease progression at 12 months
In a large Phase III clinical trial, Tasigna (nilotinib capsules) demonstrated greater efficacy over Gleevec (imatinib) in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The new clinical data were just presented as a late breaking abstract at the 51st annual meeting of the American Society of Hematology (ASH), in New Orleans, Louisiana.
CML is one of the four most common types of leukemia. It is caused by an abnormal chromosome, called the Philadelphia (Ph) chromosome which produces an abnormal cancer protein called Bcr-Abl, which is responsible for blocking the normal signal that tells the body to stop producing white blood cells. As a result, CML patients have a significantly elevated cancerous white blood cell count. A form of blood cancer, CML is estimated to affect approximately 3,000 Canadians.
Without treatment, CML typically progresses over three to five years from the initial (chronic) phase through a transition period (accelerated phase) to a rapidly fatal form (blast crisis).
At 12 months, the randomized, open-label, clinical trial (which included Canadian sites) named Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients (ENESTnd), found that significantly fewer patients progressed to the accelerated or blastic phases on Tasigna 300 mg twice daily than on Gleevec 400 mg once daily (2 patients vs. 11 patients), demonstrating a statistically significant improvement in disease control. Gleevec tablets are the established treatment standard.