Table 2.
Response outcomes in patients with R/R AML based on prior TKI therapy status in the CHRYSALIS and ADMIRAL trials.
| Response parameter | CHRYSALIS 120-/200-mg Gilteritinib | ADMIRAL 120-mg Gilteritinib vs Salvage Chemotherapy | ||||
|---|---|---|---|---|---|---|
| Prior TKI (n = 33) | No Prior TKI (n = 112) | Gilteritinib | Salvage Chemotherapy | |||
| Prior TKI (n = 33) | No Prior TKI (n = 214) | Prior TKI (n = 15) | No Prior TKI (n = 109) | |||
| Response ratea, n (%) | ||||||
| CR | 1 (3) | 16 (14) | 6 (18) | 46 (21) | 0 | 13 (12) |
| CRi | 10 (30) | 25 (22) | 7 (21) | 56 (26) | 3 (20) | 11 (10) |
| CRp | 3 (9) | 7 (6) | 4 (12) | 15 (7) | 0 | 0 |
| PR | 2 (6) | 9 (8) | 5 (16) | 28 (13) | 1 (7) | 4 (4) |
| NR | 15 (45) | 43 (38) | 9 (27) | 57 (26) | 5 (33) | 38 (35) |
| NE | 2 (6) | 12 (11) | 2 (6) | 12 (6) | 6 (40) | 43 (39) |
| CRcb | 14 (42) | 48 (43) | 17 (52) | 117 (55) | 3 (20) | 24 (22) |
| Median duration of CR, months (range) | 9.1 (9.1 to 9.1) | 15.8 (2.1 to 15.8) | 8.9 (0.7+ to 15.7 + ) | NE (0.6 to 23.1 + ) | NA | 1.8 (<0.1+ to 1.8) |
| Median duration of CRc, months (range) | 1.9 (0.3 to 12.6) | 6.3 (0.9 to 15.8) | 3.7 (0.7 to 15.7 + ) | 4.8 (<0.1+ to 30.3 + ) | NE (<0.1+ to 0.3 + ) | NE (<0.1+ to 3.7 + ) |
| By TKI Agent | Sorafenib (n = 33) | Midostaurin (n = 14) | Sorafenib (n = 19) | Midostaurin (n = 9) | Sorafenib (n = 6) | |
| Response ratea | ||||||
| CR | 1 (3) | 3 (21) | 3 (16) | 0 | 0 | |
| CRi | 10 (30) | 4 (29) | 3 (16) | 3 (33) | 0 | |
| CRp | 3 (9) | 1 (7) | 3 (16) | 0 | 0 | |
| PR | 2 (6) | 0 | 5 (26) | 1 (11) | 0 | |
| NR | 15 (45) | 5 (36) | 4 (21) | 3 (33) | 2 (33) | |
| NE | 2 (6) | 1 (7) | 1 (5) | 2 (22) | 4 (67) | |
| CRcb | 14 (42) | 8 (57) | 9 (47) | 3 (33) | 0 | |
| Median duration of CR, months (range) | 9.1 (9.1 to 9.1) | 3.7 (0.7+ to 3.7) | 12.9 (4.9 to 15.7 + ) | NA | NA | |
| Median duration of CRc, months (range) | 1.9 (0.3 to 12.6) | 3.0 (0.7 to 3.7) | 4.6 (1.0+ to 15.7 + ) | NE (0.1+ to 0.3 + ) | NA | |
Bold font indicates aggregate responses.
aIncludes pretransplant and posttransplant response. bDefined 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, NA not applicable, NE not evaluable, NR no response, PR partial remission, R/R relapsed or refractory, TKI tyrosine kinase inhibitor.