ENESTnd 4-year overall results: patient disposition and long-term end points
| . | Nilotinib 300 mg twice daily (n = 282) . | Nilotinib 400 mg twice daily (n = 281) . | Imatinib 400 mg once daily (n = 283) . |
|---|---|---|---|
| Patient disposition | |||
| Remaining on active follow up or died, % | 94 | 95 | 93 |
| Remaining on core treatment, % | 66 | 69 | 57 |
| Cumulative incidence of molecular response | |||
| MMR by 4 years, % (P value vs imatinib) | 76 (<.0001) | 73 (<.0001) | 56 |
| MR4 by 4 years, % (P value vs imatinib) | 56 (<.0001) | 50 (<.0001) | 32 |
| MR4.5 by 4 years, % (P value vs imatinib) | 40 (<.0001) | 37 (.0002) | 23 |
| Progression to AP/BC on study* | |||
| Number of events, n | 9 | 6 | 19 |
| Estimated 4-year freedom from progression to AP/BC on study, % (P value vs imatinib)† | 96.7 (.0497) | 97.8 (.0074) | 93.1 |
| HR (95% CI) | 0.46 (0.21-1.02) | 0.31 (0.12-0.77) | |
| PFS on study‡ | |||
| Number of events, n | 19 | 10 | 22 |
| Estimated 4-year PFS, % (P value vs imatinib)† | 92.7 (.5643) | 96.3 (.0264) | 92.0 |
| HR (95% CI) | 0.84 (0.45-1.54) | 0.44 (0.21-0.93) | |
| OS on study§ | |||
| Number of events, n | 15 | 9 | 19 |
| Estimated 4-year OS, % (P value vs imatinib)† | 94.3 (.4636) | 96.7 (.0498) | 93.3 |
| HR (95% CI) | 0.78 (0.39-1.53) | 0.46 (0.21-1.02) | |
| . | Nilotinib 300 mg twice daily (n = 282) . | Nilotinib 400 mg twice daily (n = 281) . | Imatinib 400 mg once daily (n = 283) . |
|---|---|---|---|
| Patient disposition | |||
| Remaining on active follow up or died, % | 94 | 95 | 93 |
| Remaining on core treatment, % | 66 | 69 | 57 |
| Cumulative incidence of molecular response | |||
| MMR by 4 years, % (P value vs imatinib) | 76 (<.0001) | 73 (<.0001) | 56 |
| MR4 by 4 years, % (P value vs imatinib) | 56 (<.0001) | 50 (<.0001) | 32 |
| MR4.5 by 4 years, % (P value vs imatinib) | 40 (<.0001) | 37 (.0002) | 23 |
| Progression to AP/BC on study* | |||
| Number of events, n | 9 | 6 | 19 |
| Estimated 4-year freedom from progression to AP/BC on study, % (P value vs imatinib)† | 96.7 (.0497) | 97.8 (.0074) | 93.1 |
| HR (95% CI) | 0.46 (0.21-1.02) | 0.31 (0.12-0.77) | |
| PFS on study‡ | |||
| Number of events, n | 19 | 10 | 22 |
| Estimated 4-year PFS, % (P value vs imatinib)† | 92.7 (.5643) | 96.3 (.0264) | 92.0 |
| HR (95% CI) | 0.84 (0.45-1.54) | 0.44 (0.21-0.93) | |
| OS on study§ | |||
| Number of events, n | 15 | 9 | 19 |
| Estimated 4-year OS, % (P value vs imatinib)† | 94.3 (.4636) | 96.7 (.0498) | 93.3 |
| HR (95% CI) | 0.78 (0.39-1.53) | 0.46 (0.21-1.02) | |
CI, confidence interval; HR, hazard ratio.
Progression to AP/BC events include progression to AP/BC or CML-related death on core or extension treatment or any progression to AP/BC reported during the follow up after discontinuation of treatment.
Kaplan-Meier estimated rates.
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.