MMR at 12 months (primary end point)
. | Nilotinib . | Imatinib . | Nilotinib vs imatinib response rate difference, % (95% CI)* . |
---|---|---|---|
Overall | 134 | 133 | — |
Patients with response | 70 (52.2) | 37 (27.8) | 24.4 (13.0-35.8) |
P vs imatinib | <.0001 | — | |
Low Sokal risk† | 69 | 69 | — |
Patients with response‡ | 44 (63.8) | 22 (31.9) | 31.9 (16.1-47.7) |
Intermediate Sokal risk† | 44 | 43 | — |
Patients with response‡ | 18 (40.9) | 13 (30.2) | 10.7 (9.3-30.7) |
High Sokal risk† | 21 | 21 | — |
Patients with response‡ | 8 (38.1) | 2 (9.5) | 28.6 (4.3-52.8) |
No prior rIFNɑ† | 123 | 122 | — |
Patients with response‡ | 64 (52.0) | 33 (27.0) | 25.0 (13.1-36.8) |
Prior rIFNɑ† | 11 | 11 | — |
Patients with response‡ | 6 (54.5) | 4 (36.4) | 18.2 (−22.7-59.1) |
. | Nilotinib . | Imatinib . | Nilotinib vs imatinib response rate difference, % (95% CI)* . |
---|---|---|---|
Overall | 134 | 133 | — |
Patients with response | 70 (52.2) | 37 (27.8) | 24.4 (13.0-35.8) |
P vs imatinib | <.0001 | — | |
Low Sokal risk† | 69 | 69 | — |
Patients with response‡ | 44 (63.8) | 22 (31.9) | 31.9 (16.1-47.7) |
Intermediate Sokal risk† | 44 | 43 | — |
Patients with response‡ | 18 (40.9) | 13 (30.2) | 10.7 (9.3-30.7) |
High Sokal risk† | 21 | 21 | — |
Patients with response‡ | 8 (38.1) | 2 (9.5) | 28.6 (4.3-52.8) |
No prior rIFNɑ† | 123 | 122 | — |
Patients with response‡ | 64 (52.0) | 33 (27.0) | 25.0 (13.1-36.8) |
Prior rIFNɑ† | 11 | 11 | — |
Patients with response‡ | 6 (54.5) | 4 (36.4) | 18.2 (−22.7-59.1) |