Table 1.
Reported Outcomes in Different Trials Employing CAR-T Cell and BiTE Therapies in RRMM
| Ide-Cel58 | Cilta-Cel102,109 | bb21217110,111 | Teclistamab112 | Cevostamab113 | Talquetamab114† | |
|---|---|---|---|---|---|---|
| Drug class | CAR-T | CAR-T | CAR-T | BiTE | BiTE | BiTE |
| Target | BCMA | BCMA | BCMA | BCMAxCD3 | FcRH5xCD3 | GPRC5DxCD3 |
| Phase | II | Ib/II | I | I/II | I | I |
| n | 128 | 97 | 72 | 165 | 160 | 95 |
| Dose | 150–450 ×106 cells | 0.75 ×106/kg cells | 150–450 ×106 cells | 0.06–1.5 mg/kg | 0.05–198 mg | 5–800 µg/kg |
| Median age (range) | 61 (33–78) | 61 (56–68) | 62 (33–74) | 64 (33–84) | 64 (33–82) | 61.5 (46–80) |
| Median prior therapies | 6 (3–16) | 6 (4–8) | 6 (3–17) | 5 (2–14) | 6 (2–18) | 6 (2–14) |
| R-ISS stage III (%) | 16 | 14 | NR | 12 | NR | 11 |
| Triple-class refractory (%) | 84 | 88 | 68 | 78 | 85 | 77 |
| Penta-drug refractory (%) | 26 | 42 | NR | 30 | NR | 20 |
| EMD (%) | 39 | 13 | NR | 17 | 21 | NR |
| Efficacy Outcomes | ||||||
| ORR | 73 | 98 | 69 | 63 | 55 | 70 |
| ≥CR | 33 | 83 | 28 | 39 | NR | 13 |
| ≥VGPR | 52 | 95 | 58 | 59 | NR | 57 |
| Median PFS (months) | 8.8 | Not reached | NR | 11.3 | NR | NR |
| Median OS | 19.4 | Not reached | NR | 18.3 | NR | NR |
| Safety Outcomes | ||||||
| CRS | ||||||
| Any grade/grade ≥3 (%) | 84/5 | 95/5 | 75/4 | 72/1 | 80/1.3 | 77/1 |
| Median time to onset (days) | 1 (1–12) | 7 (5–8)* | 2 (1–20) | 2 (1–6) | NR | 2 (1–22) |
| Median duration (days) | 5 (1–63) | 4 (3–6)* | NR | 2 (1–9) | NR | 2 (1–3) |
| Neurotoxicity/ICANS | ||||||
| Any grade/grade ≥3 (%) | 18/3 | 22/12 | 15/NR | 15/1 | May be up to 41/4 | NR |
| Median time to onset (days) | 2 (1–10) | 7 (5–8)* | 7 (2–24) | 3 (1–13) | NR | NR |
| Median duration (days) | 3 (1–26) | 4 (3–6)* | NR | 7 (1–291) | NR | NR |
Notes: *Represents interquartile range (IQR). †Includes efficacy and safety data for the 405 µg/kg SQ weekly dose.
Abbreviations: BiTE, bispecific T-cell engager; CAR-T, chimeric antigen receptor T-cell; Dara, daratumumab; CRS, cytokine release syndrome; EMD, extramedullary disease; FcRH5, Fc receptor-homolog 5; GPRC5D, G protein-coupled receptor family C group 5 member D; ICANS, immune effector cell-associated neurotoxicity syndrome; NR, not reported.