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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

r response with Tasigna for people living with this cancer."

CML is responsible for approximately 10% to 15% of all adult cases of leukemia in the US, with an incidence of one to two cases per 100,000 people per year(6,7).

ENESTcmr study detailsENESTcmr is an open-label, randomized, prospective, multi-center Phase III study of Tasigna 400 mg twice daily versus standard-dose Gleevec (400 mg or 600 mg once daily) comparing kinetics of CMR for patients with Ph+ CML in chronic phase who had achieved complete cytogenetic response (CCyR) but were still Bcr-Abl positive (i.e., had evidence of residual leukemia) after at least two years of treatment with Gleevec. The study enrolled 207 patients. The patients were randomized into one of two treatment arms: Tasigna 400 mg twice daily versus continuing Gleevec 400 mg or 600 mg once daily (same dose as at study entry)(1).

The primary endpoint was the rate of confirmed best cumulative CMR by 12 months of study therapy with Tasigna or Gleevec. Samples with any detectable level were considered not to be in CMR. The lowest detected Bcr-Abl value was 0.00073%. Secondary objectives included the kinetics of CMR, duration of CMR, progression-free survival and overall survival in both arms. CMR was defined at three levels: CMR (CMR greater than or equal to 4.5-log, undetectable Bcr-Abl by RQ-PCR at a sensitivity of less than 0.0032%), CMR4 (CMR greater than or equal to 4-log, undetectable Bcr-Abl by RQ-PCR at a sensitivity of 0.01% or less) and CMR4.5 (CMR greater than or equal to 4.5-log, undetectable Bcr-Abl by RQ-PCR at a sensitivity of 0.0032% or less)(1).

These data showed that 23% of patients taking Tasigna achieved undetectable disease (24 patients) by 12 months, compared to 11% (11 patients) taking Gleevec(1).

A majority of patients in both treatment arms received prior Gleevec treatment for at least three years before entering the trial. Patients randomized to receive Ta
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