TABLE 4.
Comparative effectiveness of cilta‐cel versus physician's choice of treatment across additional analyses
| Exploratory analysis | Sensitivity analyses | |||||||
|---|---|---|---|---|---|---|---|---|
| Main analysis | First eligible LOT only for patients in the RW cohort | 1. Enrolled population of CARTITUDE‐1 | 2. Multivariable regression | 3. Complete case | 4. Adjustment for all variables | 5. Additional inclusion criteria from CARTITUDE‐1 applied to the RW cohort | ||
| Sample size | ||||||||
| CARTITUDE‐1 | N | 97 | 97 | 113 | 97 | 97 | 97 | 97 |
| RW cohort | N OBS (ESS) | 336 (80) | 196 (32) | 482 (192) | 336 | 240 (49) | 336 (50) | 262 (60) |
| Outcome | ||||||||
| PFS |
HR a (95% CI) p‐value |
0.18 (0.12, 0.27) <0.0001 |
0.15 (0.09, 0.24) <0.0001 |
0.21 (0.14, 0.32) <0.0001 |
0.18 (0.12, 0.27) <0.0001 |
0.14 (0.09, 0.22) <0.0001 |
0.15 (0.09, 0.24) <0.0001 |
0.16 (0.11, 0.25) <0.0001 |
| TTNT |
HR a (95% CI) p‐value |
0.15 (0.09, 0.22) <0.0001 |
0.13 (0.08, 0.21) <0.0001 |
0.18 (0.12, 0.27) <0.0001 |
0.14 (0.09, 0.22) <0.0001 |
0.12 (0.07, 0.18) <0.0001 |
0.12 (0.07, 0.20) <0.0001 |
0.14 (0.09, 0.21) <0.0001 |
| OS |
HR a (95% CI) p‐value |
0.25 (0.13, 0.46) <0.0001 |
0.22 (0.11, 0.44) <0.0001 |
0.32 (0.19, 0.55) <0.0001 |
0.26 (0.15, 0.46) <0.0001 |
0.26 (0.13, 0.53) 0.0002 |
0.17 (0.08, 0.35) <0.0001 |
0.24 (0.12, 0.47) <0.0001 |
The main analysis included the following specifications: all eligible LOTs from the RW cohort, treated population of CARTITUDE‐1, inverse probability of treatment weighting, missing values imputed, and adjustment for base case variables (refractory status, cytogenetic profile, International Staging System stage, time to progression on last regimen, number of prior lines of therapy, years since multiple myeloma diagnosis, and age). For each additional analysis, one of these specifications were modified, as outlined in Table S2.
HR < 1 indicates favorable treatment effect for cilta‐cel.
Abbreviations: CI, confidence interval; ESS, effective sample size; HR, hazard ratio; LOT, line of therapy; N OBS, number of observations; OS, overall survival; PFS, progression‐free survival; RW, real world; TTNT, time to next treatment.