Table 1.
Characteristics of the efficacy population
| Parameter | N=97 |
|---|---|
| Time since initial diagnosis (years) | |
| Median | 5.9 |
| Min, max | 1.6, 18.2 |
| International Staging System (ISS) stage at study entry n (%) | |
| Stage I | 61 (62.9) |
| Stage II | 22 (22.7) |
| Stage III | 14 (14.4) |
| Light chain type, n(%) at baseline(any) | |
| Kappa light chain | 15 (15.5) |
| Lambda light chain | 9 (9.3%) |
| Biclonal | 4 (4.1) |
| Immunoglobulin, n (%) At Baseline (Any) | |
| Ig A | 8 (8.2) |
| Ig G | 57 (58.8) |
| Ig M | 2 (2.1) |
| Ig D | 2 (2.1) |
| Ig E | 0 |
| Not detected | 0 |
| Baseline cytogenetics risk n(%) | |
| High risk | 23 (23.7%) |
| Non-high risk | 68 (70.1%) |
| Missing | 6 (6.2%) |
| Presence of extramedullary plasmacytoma n (%) | |
| Yes | 13 (13.4%) |
| No | 84 (86.6%) |
| Lytic bone disease n (%) | |
| Yes | 69 (71.1) |
| No | 28 (28.9) |
| Tumor BCMA expression n (%) | |
| <50% | 5 (5) |
| ≥50% | 57 (59) |
| Unknown | 35 (36.1%) |
| Number of prior antimyeloma regimens | |
| Median (min, max) | 6 (3, 18) |
| Distribution of prior antimyeloma regimens n (%) | |
| 3 | 17 (17.5) |
| 4 | 16 (16.5) |
| 5 | 15 (15.5) |
| >5 | 49 (50.5) |
| Prior stem cell transplant n (%) | |
| Yes | 87 (89.7) |
| 1 prior transplant | 70 (72.2) |
| >1 prior transplant | 17 (17.5) |
| No | 10 (10.3) |
| Prior refractory status n (%) | |
| Immunomodulatory Agent (IMiD) | 97 (100) |
| Proteasome inhibitor (PI) | 97 (100) |
| Anti-CD38 antibodies | 97 (100) |
| Daratumumab | 94 (96.9) |
| Double refractory (IMiD and PI) | 97 (100) |
| Triple refractory (IMiD, PI and anti-CD38) | 97 (100) |
| Penta-refractory | 81 (83.5) |
| Prior refractory to last regimen, n (%) | 97 (100) |
Data from Source: BLA clinical review memorandum 125746/05