PFS and OS at 4 years by BCR-ABL level at 3 months in evaluable* patients
| . | Nilotinib 300 mg twice daily (n = 282) . | Nilotinib 400 mg twice daily (n = 281) . | Imatinib 400 mg once daily (n = 283) . |
|---|---|---|---|
| PFS on study† | |||
| BCR-ABLIS at 3 months | |||
| ≤1% | |||
| Evaluable patients/events, n | 145/6 | 136/3 | 43/2 |
| Estimated 4-year PFS, % | 95.8 | 97.8 | 95.3 |
| P value vs >1% to ≤10% | .8269 | .3660 | .2338 |
| >1% to ≤10% | |||
| Evaluable patients/events, n | 89/4 | 94/4 | 133/2 |
| Estimated 4-year PFS, % | 94.2 | 95.7 | 98.5 |
| P value vs >10% | .0351 | .1907 | <.0001 |
| ≤10% | |||
| Evaluable patients/events, n | 234/10 | 230/7 | 176/4 |
| Estimated 4-year PFS, % | 95.2 | 96.9 | 97.7 |
| P value vs >10% | .0061 | .0399 | <.0001 |
| >10% | |||
| Evaluable patients/events, n | 24/4 | 28/3 | 88/15 |
| Estimated 4-y PFS, % | 82.9 | 89.0 | 82.6 |
| OS on study‡ | |||
| BCR-ABLIS at 3 months | |||
| ≤1% | |||
| Evaluable patients/events, n | 145/5 | 137/3 | 43/2 |
| Estimated 4-year OS, % | 96.5 | 97.8 | 95.3 |
| P value vs >1% to ≤10% | .6348 | .3653 | .0982 |
| >1% to ≤10% | |||
| Evaluable patients/events, n | 89/2 | 95/4 | 133/1 |
| Estimated 4-year OS, % | 97.2 | 95.7 | 100 |
| P value vs >10% | .0219 | .5219 | <.0001 |
| ≤10% | |||
| Evaluable patients/events, n | 234/7 | 232/7 | 176/3 |
| Estimated 4-year OS, % | 96.7 | 96.9 | 98.9 |
| P value vs >10% | .0116 | .2483 | <.0001 |
| >10% | |||
| Evaluable patients/events, n | 24/3 | 28/2 | 88/14 |
| Estimated 4-year OS, % | 86.7 | 92.7 | 83.6 |
| . | Nilotinib 300 mg twice daily (n = 282) . | Nilotinib 400 mg twice daily (n = 281) . | Imatinib 400 mg once daily (n = 283) . |
|---|---|---|---|
| PFS on study† | |||
| BCR-ABLIS at 3 months | |||
| ≤1% | |||
| Evaluable patients/events, n | 145/6 | 136/3 | 43/2 |
| Estimated 4-year PFS, % | 95.8 | 97.8 | 95.3 |
| P value vs >1% to ≤10% | .8269 | .3660 | .2338 |
| >1% to ≤10% | |||
| Evaluable patients/events, n | 89/4 | 94/4 | 133/2 |
| Estimated 4-year PFS, % | 94.2 | 95.7 | 98.5 |
| P value vs >10% | .0351 | .1907 | <.0001 |
| ≤10% | |||
| Evaluable patients/events, n | 234/10 | 230/7 | 176/4 |
| Estimated 4-year PFS, % | 95.2 | 96.9 | 97.7 |
| P value vs >10% | .0061 | .0399 | <.0001 |
| >10% | |||
| Evaluable patients/events, n | 24/4 | 28/3 | 88/15 |
| Estimated 4-y PFS, % | 82.9 | 89.0 | 82.6 |
| OS on study‡ | |||
| BCR-ABLIS at 3 months | |||
| ≤1% | |||
| Evaluable patients/events, n | 145/5 | 137/3 | 43/2 |
| Estimated 4-year OS, % | 96.5 | 97.8 | 95.3 |
| P value vs >1% to ≤10% | .6348 | .3653 | .0982 |
| >1% to ≤10% | |||
| Evaluable patients/events, n | 89/2 | 95/4 | 133/1 |
| Estimated 4-year OS, % | 97.2 | 95.7 | 100 |
| P value vs >10% | .0219 | .5219 | <.0001 |
| ≤10% | |||
| Evaluable patients/events, n | 234/7 | 232/7 | 176/3 |
| Estimated 4-year OS, % | 96.7 | 96.9 | 98.9 |
| P value vs >10% | .0116 | .2483 | <.0001 |
| >10% | |||
| Evaluable patients/events, n | 24/3 | 28/2 | 88/14 |
| Estimated 4-year OS, % | 86.7 | 92.7 | 83.6 |
Patients with atypical transcripts at baseline or unevaluable PCR samples at 3 months were excluded. Patients who had a PFS event or who were censored by 3 months were excluded from the analysis of PFS. Patients with an OS event or who were censored by 3 months were excluded from the analysis of OS.
PFS events include progression to AP/BC or death from any cause on core or extension treatment or during follow up after discontinuation of treatment.
OS events include death from any cause on core or extension treatment or during follow up after discontinuation of treatment.