Table 4.
Antileukemic Response to Gilteritinib in Patients With R/R AML
| Antileukemic Response | FAS Patient Population (n=249) | FLT3WT (n=58) | FLT3mut+ | |
|---|---|---|---|---|
| All Patients (n=191) | Patients Receiving ≥80mg/d (n=169) | |||
| CR | 19 (8% [5, 12]) | 1 (2% [0, 9]) | 18 (9% [6, 15]) | 18 (11% [6, 16]) |
| CRp | 10 (4% [2, 7]) | 0 | 10 (5% [3, 9]) | 10 (6% [3, 11]) |
| CRi | 46 (19% [14, 24]) | 4 (7% [2, 17] | 42 (22% [16, 29]) | 41 (24% [18, 31]) |
| PR | 25 (10% [7, 15]) | 2 (3% [0, 12]) | 23 (12% [8, 18]) | 19 (11% [7, 17]) |
| CRca | 75 (30% [25, 36]) | 5 (9% [3, 19]) | 70 (37% [30, 44]) | 69 41% (33, 49) |
| ORRb | 100 (40% [34, 47]) | 7 (12% [5, 23]) | 93 (49% [41, 56]) | 88 (52% [44, 60]) |
| Median response durationa | 17 (14, 29) | 12 (3, 17) | 20 (14, 33) | 20 (14, 33) |
| Median overall survivalb | 25 (20, 30) | 17 (11, 21) | 30 (23, 33) | 31 (24, 59) |
CI, confidence interval; CR, complete remission; CRc, composite remission (CR+CRp+CRi); CRp, complete remission with incomplete platelet recovery; CRi, complete remission with incomplete hematologic recovery; FAS, full analysis set; PR, partial response; ORR, overall response rate (CRc+PR)
Data presented as n (% [95% CI]) unless otherwise noted.
a
Data presented as % (95% CI).
b
Data presented as weeks (95% CI).