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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

signa were given a new treatment while the others continued to receive a therapy that they had been taking for a minimum of two years(1).

During this study, discontinuation due to adverse events (AEs) occurred in 8.9% and 1% for Tasigna- and Gleevec-treated patients, respectively. The majority of these were asymptomatic laboratory adverse events. The most commonly reported AEs in the Tasigna arm were headache (36.6%), rash (23.8%) and pruritus (23.8%), while in the Gleevec arm the most commonly reported AEs were diarrhea (12.6%) and headache (9.7%)(1).

ECGs were measured at baseline (both treatment arms), at day 8 (Tasigna arm only) and at early discontinuation from study treatment (both treatment arms). No patients in the Tasigna treatment arm were reported to have QTc prolongation intervals greater than 480 msec at baseline or at day 8; four patients (4.0%) had reported QTc prolongation intervals greater than 450 msec on day 8. No patients who discontinued early had QTc prolongation intervals greater than 450 msec(1).

ENESTnd study detailsENESTnd is a Phase III randomized, open-label, multicenter trial comparing the efficacy and safety of Tasigna versus Gleevec in adult patients with newly diagnosed Ph+ CML in chronic phase. It is the largest global randomized comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients(2).

The study is being conducted at 217 global sites with 846 patients enrolled. Patients were randomized to receive Tasigna 300 mg twice daily (n=282), Tasigna 400 mg twice daily (n=281) or Gleevec 400 mg once daily (n=283). The primary endpoint was major molecular response (MMR) at 12 months; the key secondary endpoint was durable MMR at 24 months (patients having MMR when evaluated at both 12 and 24 months). MMR was defined in this study as 0.1% or less of Bcr-Abl as measured by RQ-PCR. Planned follow-up is for five years. Patients on the Gleevec treatment arm who had suboptimal response or
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