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 | |
