Table 3:

Cumulative response assessment^*

	Cohort 1		Cohort 2
	FLT3-ITD positive (n=112)	FLT3-ITD negative (n=44)	FLT3-ITD positive (n=136)	FLT3-ITD negative (n=40)
Best response
Composite complete remission	63 (56%)	16 (36%)	62 (46%)	12 (30%)
Complete remission	3 (3%)	2 (5%)	5 (4%)	1 (3%)
Complete remission with incomplete platelet recovery	4 (4%)	1 (2%)	2 (1%)	1 (3%)
Complete remission with incomplete haematological recovery	56 (50%)	13 (30%)	55 (40%)	10 (25%)
Partial remission	23 (21%)	4 (9%)	39 (29%)	6 (15%)
No response	20 (18%)	17 (39%)	24 (18%)	16 (40%)
Unknown	6 (5%)	7 (16%)	11 (8%)	6 (15%)
Overall response†	86 (77%)	20 (45%)	101 (74%)	18 (45%)
Composite complete remission after one cycle	34/63 (54%)	6/16 (38%)	39/62 (63%)	8/12 (67%)

Data are n (%) or n/N (%). One patient with unknown FLT3-ITD status was enrolled in cohort 1, but was not included in the mutation level-specific analyses; this patient achieved a composite complete remission. FLT3-ITD=FMS-like tyrosine kinase 3 internal tandem duplication.

^*Best response was determined using response data from all quizartinib cycles. Of the 44 FLT3-ITD-negative patients in cohort 1, 32 had no detectable mutation (nine [28%] of whom achieved a composite complete remission and three [9%] of whom achieved a partial remission) and 12 had a detectable but low FLT3-ITD mutation (seven [58%] of whom achieved a composite complete remission and one [8%] of whom achieved a partial remission). Of the 40 FLT3-ITD-negative patients in cohort 2, 26 had an undetectable FLT3-ITD allelic frequency (seven [27%] of whom achieved a composite complete remission and three [12%] achieved a partial remission) and 14 had a low but detectable expression of the FLT3-ITD mutation (five [36%] of whom achieved a composite complete remission and three [21%] achieved a partial remission).

^†Defined as composite complete remission plus partial remission.