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Table 3 Summary of efficacy in QuANTUM-R and ADMIRAL studies

From: Quizartinib: a potent and selective FLT3 inhibitor for the treatment of patients with FLT3-ITD–positive AML

Parameter

QuANTUM-R [46]

ADMIRAL [31]

Quizartinib

(n = 245)

Salvage chemotherapy

(n = 122)

Gilteritinib

(n = 247)

Salvage chemotherapy (n = 124)

Best response, n (%)

 CRc

118 (48.2)

33 (27.0)

134 (54.3)

27 (21.8)

 CR

10 (4.1)

1 (0.8)

52 (21.1)

13 (10.5)

 CRi

99 (40.4)

32 (26.2)

63 (25.5)

14 (11.3)

 CRh

NA

NA

32 (13.0)

6 (4.8)

Median OS, months (95% CI)

6.2 (5.3–7.2)

4.7 (4.0–5.5)

9.3 (7.7–10.7)

5.6 (4.7–7.3)

OS, HR (95% CI)

0.76 (0.58–0.98); one-sided p = 0.02

0.64 (0.49–0.83); two-sided p < 0.001

1-year OS rate, %

27

20

37

17

Eligibility

Refractory or relapsed (duration of first CRc of ≤ 6 months) to anthracycline-containing or mitoxantrone-containing chemotherapy

FLT3-ITD

Refractory or relapsed to anthracycline-containing chemotherapy or an alternative therapy appropriate to induce remission

FLT3-ITD or FLT3-TKD

  1. CI, confidence interval; CR, complete remission; CRc, composite complete remission (CR + CRp + CRi); CRh, complete remission with partial hematologic recovery; CRi, complete remission with incomplete hematologic recovery; CRp, complete remission with incomplete platelet recovery; HR, hazard ratio; NA, not assessed; OS, overall survival. FLT3-ITD, FMS-related receptor tyrosine kinase 3–internal tandem duplication; FLT3-TKD, FMS-related receptor tyrosine kinase 3–tyrosine kinase domain