Targeted Therapy
Efficacy: Phase II
An open-label, multicenter, phase II study enrolled patients with imatinib-resistant or imatinib-intolerant Ph+ CML-CP and CML-AP (Table 7).1,2 The primary and secondary endpoints of the phase II CML-CP trial arm were MCyR and CHR, respectively, whereas the primary endpoint of the CML-AP trial arm was overall confirmed hematologic response, defined as CHR, no evidence of leukemia, or return to CML-CP. The study is ongoing. The efficacy results reported here are based on the first 280 patients with CML-CP and on a total enrollment of 119 patients with CMLAP. 1,2 The median duration of treatment was 261 days (approximately 8.5 months) for CML-CP11 and 202 days (approximately 6.7 months) for CML-AP.2 Tasigna was administered as two 200-mg tablets (400 mg) twice daily, 2 hours after a meal and at least 1 hour before additional food.
| Chronic Phase (n = 280) | Accelerated Phase (n = 119) |
|
|---|---|---|
| Median time since diagnosis, months (range) | 57 (5-275) | 71 (2-298) |
| Imatinib, n (%) Resistant Intolerant without MCyR |
194 (69) 86 (31) |
96 (81) 23 (19) |
| Median time of imatinib treatment, days (25th-67th percentiles) | 973 (506-1470) | 976 (2-2163) |
| Prior hydroxyurea, % | 83 | 92 |
| Prior interferon, % | 66 | 58 |
| Prior cytarabine, % | 25 | 26 |
| Stem-cell transplant,% | 8 | 7.6 |
1. Kantarjian H, Giles F, Gattermann M, et al. Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance. Blood. 2007:110:3540-3546.
2. le Coutre P, Ottman OG, Giles F, et al. Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or intolerant accelerated phase chronic myelogenous leukemia [published online ahead of print December 10, 2007]. Blood. doi:blood-2007-04-083196v2.