Table 2.
N | CR/CRi rate, n (%) | CR, n (%) | CRi, n (%) | BFBM, n (%) | No response, n (%) | Median DOR, mo. (95% CI) | Median RFS, mo. (95% CI) | Median OS, mo. (95% CI) | |
Phase 1 and 2 patients treated at pivotal dose | 78 | 57 (73) | 47 (60) | 10 (13) | 6 (8) | 12 (15) | 18.6 (9.6 to NE) | 11.7 (6.1 to 20.5) | 25.4 (16.2 to NE) |
Prior number of therapies | |||||||||
1 | 15 | 13 (87) | 12 (80) | 1 (7) | 1 (7) | 1 (7) | 4.9 (1.8 to NE) | 6.1 (2.8 to NE) | NR (7.6 to NE) |
≥2 | 63 | 44 (70) | 35 (56) | 9 (14) | 5 (8) | 11 (17) | 20.0 (10.3 to NE) | 11.7 (2.7 to 20.5) | 25.4 (15.9 to NE) |
Prior blinatumomab | |||||||||
Yes | 38 | 24 (63) | 18 (47) | 6 (16) | 4 (11) | 8 (21) | 14.6 (9.6 to NE) | 7.3 (0 to 15.5) | 15.9 (8.3 to 25.4) |
No | 40 | 33 (83) | 29 (73) | 4 (10) | 2 (5) | 4 (10) | 18.6 (5.2 to NE) | 11.7 (6.1 to NE) | 47.0 (18.6 to NE) |
Prior inotuzumab | |||||||||
Yes | 17 | 10 (59) | 7 (41) | 3 (18) | 2 (12) | 3 (18) | 10.3 (1.0 to NE) | 2.2 (0 to 12.3) | 8.8 (2.2 to NE) |
No | 61 | 47 (77) | 40 (66) | 7 (11) | 4 (7) | 9 (15) | 18.6 (9.4 to NE) | 14.2 (6.1 to 25.4) | 47.0 (18.6 to NE) |
Prior alloSCT | |||||||||
Yes | 29 | 22 (76) | 17 (59) | 5 (17) | 2 (7) | 4 (14) | 14.6 (8.7 to 23.6) | 12.3 (2.7 to 20.5) | 25.4 (14.2 to NE) |
No | 49 | 35 (71) | 30 (61) | 5 (10) | 4 (8) | 8 (16) | NR (5.2 to NE) | 10.3 (2.7 to NE) | 47.0 (10.9 to NE) |
Phase 2 treated patients | 55 | 39 (71) | 31 (56) | 8 (15) | 4 (7) | 9 (16) | 14.6 (9.4 to NE) | 11.6 (2.7 to 20.5) | 25.4 (16.2 to NE) |
Prior number of therapies | |||||||||
1 | 10 | 9 (90) | 8 (80) | 1 (10) | 1 (10) | 0 | 4.7 (1.8 to NE) | 5.6 (0 to NE) | NR (2.1 to NE) |
≥2 | 45 | 30 (67) | 23 (51) | 7 (16) | 3 (7) | 9 (20) | 14.6 (9.4 to NE) | 11.0 (1.8 to 15.5) | 25.4 (14.2 to NE) |
Prior blinatumomab | |||||||||
Yes | 25 | 15 (60) | 10 (40) | 5 (20) | 2 (8) | 6 (24) | 19.1 (1.3 to NE) | 11.6 (0 to 25.4) | 14.2 (3.2 to 26.0) |
No | 30 | 24 (80) | 21 (70) | 3 (10) | 2 (7) | 3 (10) | 10.3 (5.2 to NE) | 11.7 (2.8 to 22.1) | NR (18.6 to NE) |
Prior inotuzumab | |||||||||
Yes | 12 | 8 (67) | 5 (42) | 3 (25) | 0 | 2 (17) | 9.6 (1.0 to 20.0) | 4.2 (0 to 12.3) | 15.9 (0.5 to NE) |
No | 43 | 31 (72) | 26 (60) | 5 (12) | 4 (9) | 7 (16) | 18.6 (9.4 to NE) | 14.2 (2.7 to 25.4) | 26.0 (18.6 to NE) |
Prior alloSCT | |||||||||
Yes | 23 | 16 (70) | 13 (57) | 3 (13) | 2 (9) | 4 (17) | 14.6 (8.7 to 23.6) | 11.7 (0 to 20.5) | 25.4 (14.2 to NE) |
No | 32 | 23 (72) | 18 (56) | 5 (16) | 2 (6) | 5 (16) | NR (4.7 to NE) | 6.1 (2.2 to NE) | NR (9.0 to NE) |
alloSCT, allogeneic stem cell transplantation; BFBM, blast-free hypoplastic or aplastic bone marrow; CR, complete remission; CRi, complete remission with incomplete hematological recovery; DOR, duration of remission; mo, month; NE, not estimable; NR, not reached; OS, overall survival; RFS, relapse-free survival.