Table 2.

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

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.