Key data from clinical trials and real-world studies of ide-cel in relapsed/refractory myeloma
| . | KarMMa-12 . | Hansen3 . | FENIX4 . | CIBMTR1 . |
|---|---|---|---|---|
| N | 128 | 159 | 159 | 821 |
| Age, y; median | 61 | 64 | 61 | 66 |
| Prior lines, median | 6 | 7 | 4 | 7 |
| TCR/Penta, % | 84/26 | 84/44 | 79/28 | 95/60 exposed |
| Prior BCMA, % | 0 | 21 | 4 | 15 |
| High risk,∗ % | 35 | 35 | 42 | 27 |
| EMD, % | 39 | 48 | 17 | 17 |
| ORR, % | 73 | 84 | 88 | 73 |
| CR, % | 33 | 42 | 47 | 25 |
| PFS, mo | 8.8 | 8.5 | 12.5 | 8.8 |
| OS, mo | 19.4 | 12.5 | 20.8 | 67% at 12 |
| TRM, % | 3 | 5 | 5 | 6 |
| CRS (grade 3+), % | 84 (5) | 82 (3) | 90 (2) | 80 (3) |
| ICANS (grade 3+), % | 18 (3) | 18 (6) | 13 (4) | 28 (5) |
| Infection rate, % | 69 | 34 | 34 | 45 |
| . | KarMMa-12 . | Hansen3 . | FENIX4 . | CIBMTR1 . |
|---|---|---|---|---|
| N | 128 | 159 | 159 | 821 |
| Age, y; median | 61 | 64 | 61 | 66 |
| Prior lines, median | 6 | 7 | 4 | 7 |
| TCR/Penta, % | 84/26 | 84/44 | 79/28 | 95/60 exposed |
| Prior BCMA, % | 0 | 21 | 4 | 15 |
| High risk,∗ % | 35 | 35 | 42 | 27 |
| EMD, % | 39 | 48 | 17 | 17 |
| ORR, % | 73 | 84 | 88 | 73 |
| CR, % | 33 | 42 | 47 | 25 |
| PFS, mo | 8.8 | 8.5 | 12.5 | 8.8 |
| OS, mo | 19.4 | 12.5 | 20.8 | 67% at 12 |
| TRM, % | 3 | 5 | 5 | 6 |
| CRS (grade 3+), % | 84 (5) | 82 (3) | 90 (2) | 80 (3) |
| ICANS (grade 3+), % | 18 (3) | 18 (6) | 13 (4) | 28 (5) |
| Infection rate, % | 69 | 34 | 34 | 45 |
BCMA, B-cell maturation antigen; CR, complete response; CRS, cytokine release syndrome; EMD, extramedullary disease; ICANS, immune effector cell–associated neurotoxicity syndrome; N, number of patients; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; TCR/Penta, triple-class refractory/penta-refractory; TRM, treatment-related mortality.
High-risk cytogenetics were defined by the individual study, all of which included t(4;14), t(14;16), and del(17p).