Glivec patients benefit from higher start dose

New data from a large, international clinical trial find that patients with newly-diagnosed chronic myeloid leukemia who received Novartis' Glivec (imatinib) at 800mg/day as their initial treatment achieved clinical milestones significantly faster than those on the standard 400mg/day dose.

The TOPS trial is the first Phase III, randomized, controlled study designed to evaluate the potential benefits of an 800mg starting dose across all risk categories of newly-diagnosed, previously-untreated patients with Philadelphia chromosome-positive chronic myeloid leukemia, noted the Swiss drug major.

Numerically, more patients achieved a major molecular response with the 800mg dose than the 400mg dose (46.4% versus 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 800mg vs 400mg arms was most pronounced in the subset of patients with the highest risk for disease progression (41.1% vs 26.2%). Also, patients in the 800mg arm achieved MMR significantly faster.