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Video: Higher Initial Dose of Gleevec Achieved Better Early Responses than Standard Dose for Patients with Chronic Myeloid Leukemia
Date:6/13/2008

- Efficacy and safety profile in large randomized Phase III study consistent with landmark IRIS trial, which established Gleevec as standard

of care - Study did not meet primary endpoint at 1 year, yet shows faster time to

molecular responses with 800 vs. 400 mg dose - Findings reinforce that monitoring blood levels of Gleevec may help

optimize treatment benefit for individual patients - Novartis committed to improving first-line treatment through additional study follow-up and completing enrollment to Tasigna vs. Gleevec trial

EAST HANOVER, N.J., June 13 /PRNewswire/ -- New data from a large, international clinical trial find that patients with newly diagnosed chronic myeloid leukemia who received Gleevec(R) (imatinib meslyate) tablets at 800 mg/day as their initial treatment achieved clinical milestones significantly faster than those receiving the standard 400 mg/day dose.

To view the Multimedia News Release, go to: http://www.prnewswire.com/mnr/novartis/33488/

The Tyrosine Kinase Inhibitor Optimization and Selectivity Study (TOPS) is the first Phase III, randomized, controlled clinical trial designed to evaluate the potential benefits of an 800 mg starting dose across all risk categories of newly diagnosed, previously untreated patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

Numerically, more patients achieved a major molecular response (MMR) with the 800 mg dose than the 400 mg dose (46.4% vs. 40.1%); however, the difference between the two arms -- the primary endpoint of the study -- was not statistically significant. This trend of improved MMR rate at 12 months in the 800 mg vs. 400 mg arms was most pronounced in the subset of patients with the highest risk for disease progression (41.1% vs. 26.2%). Further, patients in the 800 mg a
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SOURCE Novartis
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