prev next front |1 |2 |3 |4 |5 |6 |7 |8 |9 |10 |11 |12 |13 |14 |15 |16 |17 |18 |19 |20 |21 |22 |23 |24 |25 |review

More Patients Remain on Gleevec® Therapy

All Crossovers 1% (n=7) 39% (n=218)

Intolerance <1% 23%

No CHR at 6 months 0% 7%

Increasing WBC count <1% 5%

Loss of CHR 0% 4%

Loss of MCR <1% <1%

All Discontinuations 9% (n=51) 31% (n=170)

Withdrawal of consent 2% 13%

Adverse events 2% 6%

Progression to accelerated phase or blast crisis 1.5% 5%

All other causes 3.5% 7%

Remained on originally assigned treatment 90% (n=495) 30% (n=165)

IFN-α + ara-C

n=553

Gleevec

n=553

[Slide 17]

More Patients Remain on Gleevec® Therapy1,2

• There was a marked difference in crossover rates between the 2 treatment arms: 39% of

patients crossed over to the Gleevec arm vs only 1% of patients crossing over to the IFN-α +

ara-C arm.

• The primary reason for crossover in the IRIS study was intolerance of the IFN-α–based regimen (23%).

• Intolerance was defined as grades 3/4 non-hematologic toxicity that persisted despite dose

reduction and symptomatic therapy.

• Discontinuation rates were also substantially different: 31% in the IFN-α + ara-C arm vs only

1% in the Gleevec arm.

• Causes of discontinuation not shown (“All other causes”) included protocol violation, death on study, and SCT.

• As a result of both crossovers and discontinuations, only 30% of patients on IFN-α + ara-C

remained on their treatment vs 90% of patients remaining on Gleevec therapy.

References

1. Gleevec® (imatinib mesylate) Prescribing Information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2003.

2. Data on file. Novartis Pharmaceuticals Corporation, East Hanover, NJ.