Skip to main content
. 2023 Aug 30;11(8):e007118. doi: 10.1136/jitc-2023-007118

Table 2.

Efficacy and durability outcomes by prior therapies for pooled Phase 1 and 2 patients treated at the pivotal dose (N=78) and Phase 2 treated patients (N=55)

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.