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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

treatment failure were allowed to escalate dose and/or switch to Tasigna in a separate extension study. These data, presented at ASH, were the 36-month minimum follow-up(2).

Results showed that fewer patients in the core treatment group progressed to accelerated phase or blast crisis while on treatment with Tasigna at 300 mg twice daily (n=2) and 400 mg twice daily (n=3) versus Gleevec at 400 mg once daily (n=12) with 36 months of minimum follow-up. Analysis of the broader study group, including patients followed after discontinuation of the study, showed 9 patients on Tasigna 300 mg twice daily, 6 patients on Tasigna 400 mg twice daily and 19 patients on Gleevec progressed(2).

Over the past three years a total of 38 patients (5%) died during the ENESTnd study (17 patients taking Gleevec, 13 taking Tasigna 300 mg twice daily and 8 taking Tasigna 400 mg twice daily). Tasigna treatment was also associated with significantly lower rates of CML-related deaths (5 patients taking Tasigna 300 mg twice daily, 4 patients taking Tasigna 400 mg twice daily and 14 patients taking Gleevec) consistent with the significant improvement observed with progression to AP/BC. Since the last data cut-off there were a total of five CML related deaths (4 with Gleevec 400 mg once daily and 1 with Tasigna 400 mg twice daily)(2).

The median follow-up for this study was 36 months. Overall, 90% and 88% of patients remained in the study on Tasigna 300 mg twice daily and Gleevec 400 mg once daily, respectively(2).

Rates of discontinuation due to adverse events or laboratory abnormalities continued to be lowest for Tasigna 300 mg twice daily (10%) compared to Tasigna 400 mg twice daily (14%) and Gleevec 400 mg once daily (11%). The most commonly reported adverse events in the Tasigna 300 mg arm were rash (38.0%), headache (30.5%) and increased alanine aminotransferase (24.7%), while the same adverse events for Tasigna 400 mg were 43.3%, 32.9% and 29.2% respectively. I
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