Efficacy and safety after BCMA CAR-T in MM
| . | CHIP . | P value . | |
|---|---|---|---|
| Yes (n = 57) . | No (n = 47) . | ||
| Response rates | |||
| Overall response, n (%) | 49 (86) | 37 (79) | .44 |
| Best categorical response, n (%) | |||
| Complete response | 28 (49) | 18 (38) | .32 |
| Very good partial response | 11 (19) | 14 (30) | |
| Partial response | 10 (18) | 5 (11) | |
| No response | 8 (14) | 10 (21) | |
| Survival outcomes | |||
| Progression-free survival | |||
| Median (95% CI), mo | 12.0 (8.3-20.5) | 11.8 (9.2 to NR) | .85 |
| 18-month, % (95% CI) | 37 (25-54) | 37 (24-58) | |
| Overall survival | |||
| Median (95% CI) | 24.6 (16.8 to NR) | 38.1 (20.7 to NR) | .36 |
| 18-month (95% CI) | 54 (41-71) | 70 (57-87) | |
| Immune-mediated toxicities | |||
| CRS, n (%) | |||
| Any grade, n (%) | 47 (82) | 39 (83) | .99 |
| Grade 1 | 34 (60) | 23 (49) | .41 |
| Grade 2 | 13 (23) | 13 (28) | |
| Grade 3 | 0 (0) | 2 (4) | |
| Grade 4 | 0 (0) | 1 (2) | |
| Time to onset | |||
| Median (95% CI), d | 1 (1-3) | 4 (3-6) | .46 |
| Day +5 risk, % (95% CI) | 67 (52-77) | 64 (49-77) | |
| ICANS, n (%) | |||
| Any grade | 10 (18) | 14 (30) | .17 |
| Grade 1 | 3 (5) | 5 (11) | .26 |
| Grade 2 | 7 (12) | 6 (13) | |
| Grade 3 | 0 (0) | 2 (4) | |
| Grade 4 | 0 (0) | 1 (2) | |
| Time to onset | |||
| Median (95% CI), d | NR (NR to NR) | NR (NR to NR) | .16 |
| Day +10 risk, % (95% CI) | 16 (6-25) | 30 (15-42) | |
| Management, n (%) | |||
| Tocilizumab | 32 (56) | 32 (68) | .23 |
| Corticosteroids | 24 (42) | 23 (49) | .55 |
| Anakinra | 7 (12) | 8 (17) | .58 |
| Intensive care unit | 0 (0) | 2 (4) | .20 |
| . | CHIP . | P value . | |
|---|---|---|---|
| Yes (n = 57) . | No (n = 47) . | ||
| Response rates | |||
| Overall response, n (%) | 49 (86) | 37 (79) | .44 |
| Best categorical response, n (%) | |||
| Complete response | 28 (49) | 18 (38) | .32 |
| Very good partial response | 11 (19) | 14 (30) | |
| Partial response | 10 (18) | 5 (11) | |
| No response | 8 (14) | 10 (21) | |
| Survival outcomes | |||
| Progression-free survival | |||
| Median (95% CI), mo | 12.0 (8.3-20.5) | 11.8 (9.2 to NR) | .85 |
| 18-month, % (95% CI) | 37 (25-54) | 37 (24-58) | |
| Overall survival | |||
| Median (95% CI) | 24.6 (16.8 to NR) | 38.1 (20.7 to NR) | .36 |
| 18-month (95% CI) | 54 (41-71) | 70 (57-87) | |
| Immune-mediated toxicities | |||
| CRS, n (%) | |||
| Any grade, n (%) | 47 (82) | 39 (83) | .99 |
| Grade 1 | 34 (60) | 23 (49) | .41 |
| Grade 2 | 13 (23) | 13 (28) | |
| Grade 3 | 0 (0) | 2 (4) | |
| Grade 4 | 0 (0) | 1 (2) | |
| Time to onset | |||
| Median (95% CI), d | 1 (1-3) | 4 (3-6) | .46 |
| Day +5 risk, % (95% CI) | 67 (52-77) | 64 (49-77) | |
| ICANS, n (%) | |||
| Any grade | 10 (18) | 14 (30) | .17 |
| Grade 1 | 3 (5) | 5 (11) | .26 |
| Grade 2 | 7 (12) | 6 (13) | |
| Grade 3 | 0 (0) | 2 (4) | |
| Grade 4 | 0 (0) | 1 (2) | |
| Time to onset | |||
| Median (95% CI), d | NR (NR to NR) | NR (NR to NR) | .16 |
| Day +10 risk, % (95% CI) | 16 (6-25) | 30 (15-42) | |
| Management, n (%) | |||
| Tocilizumab | 32 (56) | 32 (68) | .23 |
| Corticosteroids | 24 (42) | 23 (49) | .55 |
| Anakinra | 7 (12) | 8 (17) | .58 |
| Intensive care unit | 0 (0) | 2 (4) | .20 |
CI, confidence interval; NR, not reached.