Review of clinical data sets for currently FDA-approved CAR T-cell therapies
| . | Ide-cel (KarMMa-1) . | Ide-cel (KarMMa-3) . | Cilta-cel (CARTITUDE-1) . | Cilta-cel (CARTITUDE-4) . |
|---|---|---|---|---|
| Trial phase | 2 | 3 | 1b/2 | 3 |
| No. of patients infused (enrolled) | 128 (140) | 225 (254) | 97 (113) | 208 (176) |
| Median age (range),† y | 61 (33-78) | 63 (30-81) | Not reported | 61.5 (27-78) |
| Median time since diagnosis (range),† y | 6 (1-18) | 4.1 (0.6-21.8) | 5.9 (4.4-8.4) | 3.0 (0.3-18.1) |
| Median No. of prior lines (range)† | 6 (3-16) | 3 (2-4) | 6 (4-8) | 2 (1-3) |
| EMD,† No. (%) | 50 (39) | 61 (24) | 13 (13) | 44 (21.2) |
| ECOG,† No. (%) | ||||
| 0 | 57 (45) | 120 (47) | 39 (40) | 114 (54.8) |
| 1 | 68 (53) | 133 (52) | 54 (56) | 93 (44.7) |
| ≥2 | 3 (2) | 1 (<1) | 4 (4) | 1 (0.5) |
| R-ISS† | ||||
| I | 14 (11) | 50 (20) | 61 (63) | 136 (65.4) |
| II | 90 (70) | 150 (59) | 22 (23) | 60 (28.8) |
| III | 21 (16) | 31 (12) | 14 (14) | 12 (5.8) |
| Unknown | 3 (2) | 23 (9) | 0 | |
| Cytogenetic abnormalities† | ||||
| High risk | 45 (35) | 107 (42) | 23 (24) | 123 (59.4)‡ |
| del(17p) | 23 (18) | 66 (26) | 19 (20) | 49 (23.7) |
| t(4;14) | 23 (18) | 43 (17) | 2 (2) | 30 (14.5) |
| t(14;16) | 6 (5) | 8 (3) | 3 (3) | 3 (1.4) |
| Prior ASCT† | 120 (94) | 214 (84) | 87 (90) | Not reported |
| Prior treatment refractory status† | ||||
| IMiD | 126 (98) | 224 (88) | Not grouped (highest is Len with 96, 99%) | 208 (100) |
| PI | 116 (91) | 189 (74) | Not grouped (highest is V with 92, 95%) | Not grouped (highest is V with 55, 26.4%) |
| Anti-CD38 | 120 (94) | 242 (95) | 94 (97) | 50 (24) |
| Triple-class refractory | 108 (84) | 164 (65) | 85 (88) | 30 (14.4) |
| Penta drug refractory | 33 (26) | 15 (6) | 41 (42) | 2 (1) |
| No. (%) requiring bridging therapy† | 112 (88) | 213 (84) | Not reported | All |
| Response rate | ||||
| MRD negative, No. (%) | 33 (24) | 51 (20)* | 43 (38) | 126 (60.6) |
| sCR or CR | 42 (30) | 98 (39) | 80 (71) | 152 (73.1) |
| ≥ VGPR | 68 (48) | 153 (60) | 92 (81) | 169 (81.3) |
| ≥ PR/ORR | 85 (67) | 181 (71) | 95 (84) | 176 (84.6) |
| Median PFS (95% CI),† mo | 8.8 (5.6-11.6) | 13.3 (11.8-16.1) | 34.9 (25.2-NR)39 | NR (Not reported) |
| Median OS (95% CI),† mo | 19.4 (18.2-NR) | Not reported | NR (NE) | NR (NE) |
| Grade 3+ CRS,† No. (%) | 8 (6) | 11 (4) | 4 (4) | 2 (1.1) |
| Grade 3-4 heme tox,† No. (%) | 114 (89) | 218 (87) | 96 (99) | 196 (94.2) |
| . | Ide-cel (KarMMa-1) . | Ide-cel (KarMMa-3) . | Cilta-cel (CARTITUDE-1) . | Cilta-cel (CARTITUDE-4) . |
|---|---|---|---|---|
| Trial phase | 2 | 3 | 1b/2 | 3 |
| No. of patients infused (enrolled) | 128 (140) | 225 (254) | 97 (113) | 208 (176) |
| Median age (range),† y | 61 (33-78) | 63 (30-81) | Not reported | 61.5 (27-78) |
| Median time since diagnosis (range),† y | 6 (1-18) | 4.1 (0.6-21.8) | 5.9 (4.4-8.4) | 3.0 (0.3-18.1) |
| Median No. of prior lines (range)† | 6 (3-16) | 3 (2-4) | 6 (4-8) | 2 (1-3) |
| EMD,† No. (%) | 50 (39) | 61 (24) | 13 (13) | 44 (21.2) |
| ECOG,† No. (%) | ||||
| 0 | 57 (45) | 120 (47) | 39 (40) | 114 (54.8) |
| 1 | 68 (53) | 133 (52) | 54 (56) | 93 (44.7) |
| ≥2 | 3 (2) | 1 (<1) | 4 (4) | 1 (0.5) |
| R-ISS† | ||||
| I | 14 (11) | 50 (20) | 61 (63) | 136 (65.4) |
| II | 90 (70) | 150 (59) | 22 (23) | 60 (28.8) |
| III | 21 (16) | 31 (12) | 14 (14) | 12 (5.8) |
| Unknown | 3 (2) | 23 (9) | 0 | |
| Cytogenetic abnormalities† | ||||
| High risk | 45 (35) | 107 (42) | 23 (24) | 123 (59.4)‡ |
| del(17p) | 23 (18) | 66 (26) | 19 (20) | 49 (23.7) |
| t(4;14) | 23 (18) | 43 (17) | 2 (2) | 30 (14.5) |
| t(14;16) | 6 (5) | 8 (3) | 3 (3) | 3 (1.4) |
| Prior ASCT† | 120 (94) | 214 (84) | 87 (90) | Not reported |
| Prior treatment refractory status† | ||||
| IMiD | 126 (98) | 224 (88) | Not grouped (highest is Len with 96, 99%) | 208 (100) |
| PI | 116 (91) | 189 (74) | Not grouped (highest is V with 92, 95%) | Not grouped (highest is V with 55, 26.4%) |
| Anti-CD38 | 120 (94) | 242 (95) | 94 (97) | 50 (24) |
| Triple-class refractory | 108 (84) | 164 (65) | 85 (88) | 30 (14.4) |
| Penta drug refractory | 33 (26) | 15 (6) | 41 (42) | 2 (1) |
| No. (%) requiring bridging therapy† | 112 (88) | 213 (84) | Not reported | All |
| Response rate | ||||
| MRD negative, No. (%) | 33 (24) | 51 (20)* | 43 (38) | 126 (60.6) |
| sCR or CR | 42 (30) | 98 (39) | 80 (71) | 152 (73.1) |
| ≥ VGPR | 68 (48) | 153 (60) | 92 (81) | 169 (81.3) |
| ≥ PR/ORR | 85 (67) | 181 (71) | 95 (84) | 176 (84.6) |
| Median PFS (95% CI),† mo | 8.8 (5.6-11.6) | 13.3 (11.8-16.1) | 34.9 (25.2-NR)39 | NR (Not reported) |
| Median OS (95% CI),† mo | 19.4 (18.2-NR) | Not reported | NR (NE) | NR (NE) |
| Grade 3+ CRS,† No. (%) | 8 (6) | 11 (4) | 4 (4) | 2 (1.1) |
| Grade 3-4 heme tox,† No. (%) | 114 (89) | 218 (87) | 96 (99) | 196 (94.2) |
ASCT, Autologous stem cell transplantation; ECOG, Eastern Cooperative Oncology Group; IMiD, immunomodulatory drug; NE, Not estimable; NR, Not reached; PI, proteasome inhibitor; PR, partial response; R-ISS, Revised International Staging System; sCR, stringent complete response; VGPR, very good partial response.
ORR are for all patients enrolled (and not enriched for those receiving cell infusion as reported in the manuscript).
Values reported for only the patients who received ide-cel infusion (full data not reported) in the KarMMa-1 and CARTITUDE-1 population. Values include all enrolled patients in the KarMMa-3 and CARTITUDE-4 populations.
High risk in this trial included +1q in addition to del(17p), t(4;14), and t(14;16) as included in the other studies.