Treatment response assessed by IRC, in ITT population, and duration of response
| Time, n (%) . | Ide-cel (n = 254) . | SRs (n = 132) . |
|---|---|---|
| ORR∗ | ||
| Number of patients with response, n | 181 | 56 |
| Percentage of patients with response, % (95% CI)† | 71 (66-77) | 42 (34-51) |
| Common rate difference (95% CI)‡ | 29 (19-39) | |
| Common odds ratio‡ | 3.44 (2.20-5.40) | |
| CR rate§ | ||
| Number of patients with a CR, n | 111 | 7 |
| Percentage of patients with CR, % (95% CI)† | 44 (38-50) | 5 (2-9) |
| Common rate difference (95% CI)‡ | 38 (31-45) | |
| CR at 24 mo, n (%) | 50 (20) | 5 (4) |
| BOR, n (%) | ||
| sCR | 103 (41) | 6 (5) |
| CR | 8 (3) | 1 (1) |
| VGPR | 45 (18) | 15 (11) |
| PR | 25 (10) | 34 (26) |
| MR | 4 (2) | 8 (6) |
| SD | 31 (12) | 49 (37) |
| PD | 24 (9) | 10 (8) |
| Not evaluable/not done | 14 (6) | 9 (7) |
| Median time from randomization to response, mo (range)|| | 2.8 (1.1-13.0) | 2.1 (0.8-9.4) |
| Median DOR, mo (95% CI)¶,# | 16.6 (12.1-19.6) | 9.7 (5.5-16.1) |
| DOR rate at 18 mo, % (SE)∗∗ | 46 (3.8) | 28 (6.4) |
| MRD-negative CR rate, n/N (%)†† | 57/163 (35) | 1/54 (2) |
| 95% CI | 27.6-42.3 | 0.0-5.4 |
| Time, n (%) . | Ide-cel (n = 254) . | SRs (n = 132) . |
|---|---|---|
| ORR∗ | ||
| Number of patients with response, n | 181 | 56 |
| Percentage of patients with response, % (95% CI)† | 71 (66-77) | 42 (34-51) |
| Common rate difference (95% CI)‡ | 29 (19-39) | |
| Common odds ratio‡ | 3.44 (2.20-5.40) | |
| CR rate§ | ||
| Number of patients with a CR, n | 111 | 7 |
| Percentage of patients with CR, % (95% CI)† | 44 (38-50) | 5 (2-9) |
| Common rate difference (95% CI)‡ | 38 (31-45) | |
| CR at 24 mo, n (%) | 50 (20) | 5 (4) |
| BOR, n (%) | ||
| sCR | 103 (41) | 6 (5) |
| CR | 8 (3) | 1 (1) |
| VGPR | 45 (18) | 15 (11) |
| PR | 25 (10) | 34 (26) |
| MR | 4 (2) | 8 (6) |
| SD | 31 (12) | 49 (37) |
| PD | 24 (9) | 10 (8) |
| Not evaluable/not done | 14 (6) | 9 (7) |
| Median time from randomization to response, mo (range)|| | 2.8 (1.1-13.0) | 2.1 (0.8-9.4) |
| Median DOR, mo (95% CI)¶,# | 16.6 (12.1-19.6) | 9.7 (5.5-16.1) |
| DOR rate at 18 mo, % (SE)∗∗ | 46 (3.8) | 28 (6.4) |
| MRD-negative CR rate, n/N (%)†† | 57/163 (35) | 1/54 (2) |
| 95% CI | 27.6-42.3 | 0.0-5.4 |
Per IMWG uniform response criteria and as specified by the protocol. 95% CI was calculated using 2-sided Wald interval. Definitions of response and disease progression were modified from IMWG criteria.24 An overall response was defined as a PR or better. CR was defined as a complete response or a stringent complete response. An sCR was defined as a CR with a normal serum-free light-chain ratio and an absence of clonal plasma cells according to the IMWG response criteria.24 Percentages may not total 100 because of rounding.
BOR, best overall response; DOR, duration of response; IMWG, International Myeloma Working Group; MR, minimal response; PR, partial response; sCR, stringent CR; SD, stable disease; SE, standard error; VGPR, very good partial response.
Patients with PR or better.
CI is a 2-sided Wald CI.
Based on Mantel-Haenszel estimate.
Patients with CR or sCR.
In patients treated with ide-cel (n = 225), median time from ide-cel infusion to response was 1.0 months (range, 0.9-10.4).
Based on KM estimation per IRC based on IMWG criteria.
In patients with a response.
Based on the Greenwood formula.
Defined as ≥1 negative MRD value within 3 months before achieving ≥CR until PD or death. MRD was assessed by next-generation sequencing at a sensitivity of 10−5 per IMWG uniform response criteria and as specified by the protocol. 95% CI was calculated using 2-sided Wald interval. MRD-negative CR rate is shown in patients who had evaluable samples (163 in the ide-cel arm and 54 in the standard regimens arm).