Table 3.
Response outcomes in patients with R/R AML by prior TKI status according to FLT3 mutation type in the CHRYSALIS and ADMIRAL studies.
| CHRYSALIS Trial: 120- or 200-mg Gilteritinib | |||||||
|---|---|---|---|---|---|---|---|
| Response parameter, n (%) | Prior TKI | No Prior TKI | |||||
| FLT3-ITD (n = 29) | FLT3-ITD and -TKD (n = 4) | FLT3-ITD (n = 94) | FLT3-TKD (n = 9) | FLT3-ITD and -TKD (n = 7) | |||
| CR | 1 (3) | 0 | 16 (17) | 0 | 0 | ||
| CRi | 8 (28) | 2 (50) | 20 (21) | 1 (11) | 4 (57) | ||
| CRp | 3 (10) | 0 | 7 (7) | 0 | 0 | ||
| PR | 2 (7) | 0 | 6 (6) | 1 (11) | 1 (14) | ||
| NR | 13 (45) | 2 (50) | 34 (36) | 7 (78) | 1 (14) | ||
| NE | 2 (7) | 0 | 11 (12) | 0 | 1 (14) | ||
| CRca | 12 (41) | 2 (50) | 43 (46) | 1 (11) | 4 (57) | ||
| ADMIRAL Trial: 120-mg Gilteritinib | |||||||
| Response parameter, n (%) | Prior TKI | No Prior TKI | |||||
| FLT3-ITD (n = 24) | FLT3-TKD (n = 5) | FLT3-ITD and -TKD (n = 4) | FLT3-ITD (n = 191) | FLT3-TKD (n = 16) | FLT3-ITD and -TKD (n = 3) | ||
| CR | 2 (8) | 2 (40) | 2 (50) | 42 (22) | 2 (13) | 0 | |
| CRi | 6 (25) | 0 | 1 (25) | 53 (28) | 2 (13) | 1 (33) | |
| CRp | 3 (13) | 1 (20) | 0 | 12 (6) | 2 (13) | 1 (33) | |
| PR | 5 (21) | 0 | 0 | 23 (12) | 5 (31) | 0 | |
| NR | 7 (29) | 1 (20) | 1 (25) | 50 (26) | 5 (31) | 1 (33) | |
| NE | 1 (4) | 1 (20) | 0 | 11 (6) | 0 | 0 | |
| CRca | 11 (46) | 3 (60) | 3 (75) | 107 (56) | 6 (38) | 2 (67) | |
Bold font indicates aggregate responses.
aDefined as the sum of patients who achieved CR, CRi, and CRc.
AML acute myeloid leukemia, CR complete remission, CRc composite complete remission, CRi complete remission with incomplete hematologic recovery, CRp complete remission with incomplete platelet recovery, ITD internal tandem duplication, NE not evaluable, NR no response, PR partial remission, R/R relapsed or refractory, TKD tyrosine kinase domain, TKI tyrosine kinase inhibitor.