Summary of time-to-event endpoint outcomes: OS, EFS, and TTF
| . | Enasidenib . | CCR . |
|---|---|---|
| OS | ||
| ITT population | N = 158 | N = 161 |
| Median (95% CI), mo | 6.5 (5.5-9.5) | 6.2 (4.6-7.7) |
| Enasidenib vs CCR: HR (95% CI); log-rank P | 0.86 (0.67-1.10); P = .23 | |
| mITT population∗ | n = 90 | n = 80 |
| Median (95% CI), mo | 6.9 (5.9-10.0) | 5.4 (4.3-7.3) |
| Enasidenib vs CCR: HR (95% CI); log-rank P | 0.70 (0.50-0.98); P = .034 | |
| EFS | ||
| ITT population | N = 158 | N = 161 |
| Median (95% CI), mo | 4.9 (3.7-5.9) | 2.6 (1.9-4.4) |
| Enasidenib vs CCR: HR (95% CI); log-rank P | 0.68 (0.52-0.91); P = .008 | |
| TTF | ||
| ITT population | N = 158 | N = 161 |
| Median (95% CI), mo | 4.9 (4.0-6.0) | 1.9 (1.4-2.5) |
| Enasidenib vs CCR: HR (95% CI); log-rank P | 0.53 (0.41-0.67); P < .0001 | |
| . | Enasidenib . | CCR . |
|---|---|---|
| OS | ||
| ITT population | N = 158 | N = 161 |
| Median (95% CI), mo | 6.5 (5.5-9.5) | 6.2 (4.6-7.7) |
| Enasidenib vs CCR: HR (95% CI); log-rank P | 0.86 (0.67-1.10); P = .23 | |
| mITT population∗ | n = 90 | n = 80 |
| Median (95% CI), mo | 6.9 (5.9-10.0) | 5.4 (4.3-7.3) |
| Enasidenib vs CCR: HR (95% CI); log-rank P | 0.70 (0.50-0.98); P = .034 | |
| EFS | ||
| ITT population | N = 158 | N = 161 |
| Median (95% CI), mo | 4.9 (3.7-5.9) | 2.6 (1.9-4.4) |
| Enasidenib vs CCR: HR (95% CI); log-rank P | 0.68 (0.52-0.91); P = .008 | |
| TTF | ||
| ITT population | N = 158 | N = 161 |
| Median (95% CI), mo | 4.9 (4.0-6.0) | 1.9 (1.4-2.5) |
| Enasidenib vs CCR: HR (95% CI); log-rank P | 0.53 (0.41-0.67); P < .0001 | |
CCR, conventional care regimen; CI, confidence interval; EFS, event-free survival; HR, hazard ratio; ITT, intention-to-treat; mITT, modified ITT; OS, overall survival; TTF, time to treatment failure.
The mITT population included patients who had an independent confirmation of AML diagnosis, had no major protocol violations, received ≥1 dose of the study drug, and had ≥1 postrandomization efficacy assessment.