Two Phase III trials show benefits of Tasigna (Novartis) for patients with Ph+ CML

New results from two Phase III clinical trials further establish the benefits of Tasigna (nilotinib), from Novartis, compared to Gleevec (imatinib mesylate) in the treatment of Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML) in newly diagnosed patients and in those with residual disease who switched to Tasigna after long-term treatment with Gleevec. Two-year results from ENESTcmr showed that switching to Tasigna led to deeper molecular responses in patients who still had evidence of residual disease after long-term therapy with Gleevec1. More than twice as many patients treated with Tasigna continued to achieve undetectable BCR-ABL versus Gleevec.

The difference between groups by 24 months was statistically significant (22.1% vs. 8.7%; p=0.0087) and that difference has doubled since the 12-month analysis. Significantly more patients treated with Tasigna achieved MR4.5 or undetectable BCR-ABL versus Gleevec regardless of the BCR-ABL transcript level at baseline1. In studies published to date, no patients achieving and maintaining MR4.5 have progressed to advanced stages of CML. Results were presented at the meeting of the American Society of Hematology.