Patient characteristics for the safety population
| Characteristic . | Blinatumomab, N = 267 . | SOC, N = 109 . |
|---|---|---|
| Mean age (range), y | 40.7 (18-80) | 41.0 (18-76) |
| Male sex, n (%) | 159 (60) | 64 (59) |
| ECOG performance status, n (%) | ||
| 0 | 95 (36) | 41 (38) |
| 1 | 133 (50) | 48 (44) |
| 2 | 39 (15) | 19 (17) |
| Unknown | 0 (0) | 1 (1) |
| Key inclusion criteria, n (%) | ||
| Refractory to primary or salvage therapy | 112 (42) | 43 (39) |
| First relapse, first remission <12 mo | 76 (28) | 30 (28) |
| Untreated second or greater relapse* | 31 (12) | 14 (13) |
| Relapsed after alloHSCT* | 46 (17) | 22 (20) |
| No criteria met | 2 (1) | 0 (0) |
| Prior alloHSCT, n (%) | ||
| Yes | 93 (35) | 35 (32) |
| No | 173 (65) | 73 (67) |
| Unknown | 1 (<1) | 1 (1) |
| First relapse with remission duration <12 mo, n (%) | ||
| Yes | 108 (40) | 37 (34) |
| No | 158 (59) | 72 (66) |
| Unknown | 1 (<1) | 0 (0) |
| Salvage status, n (%) | ||
| First | 112 (42) | 55 (50) |
| Second | 91 (34) | 34 (31) |
| Third or later | 64 (24) | 20 (18) |
| Bone marrow blasts (central/local), n (%) | ||
| >5% to <10% | 9 (3) | 4 (4) |
| 10% to <50% | 60 (22) | 19 (17) |
| ≥50% | 198 (74) | 86 (79) |
| Peripheral blasts, n (%) | ||
| 0 | 116 (43) | 43 (39) |
| 1 to 5 × 109/L | 70 (26) | 40 (37) |
| >5 × 109/L | 31 (12) | 12 (11) |
| Unknown | 50 (19) | 14 (13) |
| White blood cells at diagnosis, n (%) | ||
| <30 × 109/L | 141 (53) | 50 (46) |
| ≥30 × 109/L | 69 (26) | 34 (31) |
| Unknown | 57 (21) | 25 (23) |
| Platelets, mean (range), × 109/L | 71.3 (2-454) | 93.1 (8-580) |
| ALT or AST >3× ULN, n (%) | 35 (13) | 10 (9) |
| Patients with history of events of clinical interest, n (%) | ||
| Neutropenias | 58 (22) | 15 (14) |
| Thrombocytopenias | 76 (28) | 34 (31) |
| Leukopenias | 15 (6) | 4 (4) |
| Acute and chronic pancreatitis | 2 (1) | 3 (3) |
| Injection and infusion site reaction | 1 (<1) | 2 (2) |
| Characteristic . | Blinatumomab, N = 267 . | SOC, N = 109 . |
|---|---|---|
| Mean age (range), y | 40.7 (18-80) | 41.0 (18-76) |
| Male sex, n (%) | 159 (60) | 64 (59) |
| ECOG performance status, n (%) | ||
| 0 | 95 (36) | 41 (38) |
| 1 | 133 (50) | 48 (44) |
| 2 | 39 (15) | 19 (17) |
| Unknown | 0 (0) | 1 (1) |
| Key inclusion criteria, n (%) | ||
| Refractory to primary or salvage therapy | 112 (42) | 43 (39) |
| First relapse, first remission <12 mo | 76 (28) | 30 (28) |
| Untreated second or greater relapse* | 31 (12) | 14 (13) |
| Relapsed after alloHSCT* | 46 (17) | 22 (20) |
| No criteria met | 2 (1) | 0 (0) |
| Prior alloHSCT, n (%) | ||
| Yes | 93 (35) | 35 (32) |
| No | 173 (65) | 73 (67) |
| Unknown | 1 (<1) | 1 (1) |
| First relapse with remission duration <12 mo, n (%) | ||
| Yes | 108 (40) | 37 (34) |
| No | 158 (59) | 72 (66) |
| Unknown | 1 (<1) | 0 (0) |
| Salvage status, n (%) | ||
| First | 112 (42) | 55 (50) |
| Second | 91 (34) | 34 (31) |
| Third or later | 64 (24) | 20 (18) |
| Bone marrow blasts (central/local), n (%) | ||
| >5% to <10% | 9 (3) | 4 (4) |
| 10% to <50% | 60 (22) | 19 (17) |
| ≥50% | 198 (74) | 86 (79) |
| Peripheral blasts, n (%) | ||
| 0 | 116 (43) | 43 (39) |
| 1 to 5 × 109/L | 70 (26) | 40 (37) |
| >5 × 109/L | 31 (12) | 12 (11) |
| Unknown | 50 (19) | 14 (13) |
| White blood cells at diagnosis, n (%) | ||
| <30 × 109/L | 141 (53) | 50 (46) |
| ≥30 × 109/L | 69 (26) | 34 (31) |
| Unknown | 57 (21) | 25 (23) |
| Platelets, mean (range), × 109/L | 71.3 (2-454) | 93.1 (8-580) |
| ALT or AST >3× ULN, n (%) | 35 (13) | 10 (9) |
| Patients with history of events of clinical interest, n (%) | ||
| Neutropenias | 58 (22) | 15 (14) |
| Thrombocytopenias | 76 (28) | 34 (31) |
| Leukopenias | 15 (6) | 4 (4) |
| Acute and chronic pancreatitis | 2 (1) | 3 (3) |
| Injection and infusion site reaction | 1 (<1) | 2 (2) |
ALT, alanine aminotransferase; AST, aspartate aminotransferase; ECOG, Eastern Cooperative Oncology Group; ULN, upper limit of normal.
Patients who met none of the above inclusion criteria.