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Two Novartis Phase III Studies Show Twice as Many Ph+ CML Patients Achieve Deeper Levels of Response With Tasigna® Compared to Gleevec®
Date:12/12/2011

EAST HANOVER, N.J., Dec. 12, 2011 /PRNewswire/ -- Phase III clinical trial data presented today contribute to the growing evidence that adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase who are treated with Tasigna® (nilotinib) have deeper levels of response compared to those treated with Gleevec® (imatinib mesylate) tablets(*1,2).

The findings from the ENEST (Evaluating Nilotinib Efficacy and Safety in clinical Trials) clinical research program were presented at the 53rd Annual Meeting of the American Society of Hematology (ASH) in San Diego.

ENESTcmr is the first exploratory randomized trial to investigate the impact of switching adult patients with residual disease after a minimum of two years of treatment with Gleevec to Tasigna to determine if a deeper level of response could be achieved(1).

The study showed that twice as many patients switched to Tasigna 400 mg twice a day achieved undetectable Bcr-Abl levels by 12 months compared to Gleevec (23% taking Tasigna 400 mg twice daily and 11% taking Gleevec 400 mg or 600 mg once daily; p= 0.0202). The primary endpoint, which is more stringent than conventional measures, is undetectable Bcr-Abl level in two consecutive samples. Samples with any detectable level were not considered to be in complete molecular response (CMR). The lowest detected Bcr-Abl value was 0.00073%. This endpoint showed a two-fold difference in confirmed undetectable CMR for 13% of patients on Tasigna versus 6% of patients on Gleevec, although statistical significance was not achieved (p=0.108). The study has a planned follow-up of four years(1).

After 36 months of follow-up, data from the Phase III ENESTnd clinical trial in adult patients with newly diagnosed Ph+ CML in chronic phase continued to show significantly more patients achieved CMR, defined in this study as at least a 4.5 log reduction from baseline or a trac
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SOURCE Novartis
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