About Tasigna

Tasigna Efficacy

In clinical trials, Tasigna produced a 74% complete hematologic response (CHR) rate in chronic phase.

52% of Ph+ CML patients in chronic phase achieved a major cytogenetic response (CyR); 34% of these patients achieved a complete CyR.

Response was rapid and durable:

2.8 months: median time to major CyR in patients in the chronic phase.
The majority of patients experienced ongoing response during at least 6 months of follow-up (median duration not yet reached, with the exception of patients without a baseline CHR, who had a median duration of MCyR of 12.9 months).

Nearly three-fourths of patients in chronic phase achieved a complete hematologic response (CHR) with Tasigna.

Of the 185 patients who had not achieved a CHR with Glivec, 74% achieved a CHR with Tasigna.

Responses were strong, whether patients were resistant or intolerant to Glivec.

Among 132 primary enrollment patients in chronic phase

50% of patients with resistant disease achieved a major CyR
48% of patients intolerant of Glivec achieved a major CyR — Patients considered intolerant of Glivec were eligible for clinical trials of Tasigna only if they also had not achieved a major CyR

Responses with Tasigna were achieved in heavily pretreated patients with long duration of disease:

Approximately 5 years histologically confirmed disease for Ph+ CML patients in the chronic phase

30% of Ph+ CML patients achieved a major CyR, of which 15.6% achieved a CCyR
45% of patients achieved an HR, of which 19% achieved a CHR
1.0 month: time to confirmed HR in patients
The majority of Ph+ CML patients in the accelerated phase experienced ongoing response during at least 6 months of follow-up (median duration not yet reached).

Ph+ CML patients in both chronic and accelerated phase achieved a high planned dose intensity with Tasigna.

Median dose intensity was 797.6 mg/day of a planned 800 mg/day (99.6%)
Range was 145 to 1149.0 mg/day
Based on study design, 41 patients (12.9%) in chronic phase and 24 patients (22.8%) in accelerated phase were dose escalated to 1200 mg/day.

Source:

Nilotinib Summary of Clinical Efficacy in CML-CP or CML-AP: 120-Day Update. Novartis Pharmaceuticals: East Hanover, NJ; 2007.