Table 1.
Arm 1 (lete-cel) (N = 3) | Arm 2 (lete-cel + pembrolizumab) (N = 3) | Total (N = 6) | |
---|---|---|---|
Median age, y (range) | 60.0 (59-79) | 64.0 (62-67) | 63.0 (59-79) |
Male sex, n (%) | 3 (100) | 3 (100) | 6 (100) |
HLA status, n (%) | |||
HLA-A∗02:01–positive | 3 (100) | 3 (100) | 6 (100) |
NY-ESO-1/LAGE-1a status, n (%)∗ | |||
NY-ESO-1–positive | 2 (67) | 2 (67) | 4 (67) |
LAGE-1a–positive | 3 (100) | 2 (67) | 5 (83) |
Median time from initial diagnosis to screening, mo (range)† | n = 1 50.7 (50.7-50.7) |
n = 2 30.2 (7.3-53.1) |
n = 3 50.7 (7.3-53.1) |
Disease stage at initial diagnosis, n (%) | |||
Stage I/II | 1 (33) | 0 | 1 (17) |
Stage III | 1 (33) | 1 (33) | 2 (33) |
Unknown | 1 (33) | 2 (67) | 3 (50) |
History of autologous HCT, n (%) | |||
Yes | 1 (33) | 1 (33) | 2 (33) |
Adverse cytogenetics, n (%)‡ | n = 1 | n = 3 | n = 4 |
t(4;14) | 0 | 2 (67) | 2 (50) |
1q amplification | 1 (100) | 2 (67) | 3 (75) |
Prior number of systemic therapy regimens, n (%) | |||
2 | 0 | 1 (33) | 1 (33) |
3 | 2 (67) | 0 | 2 (67) |
5 | 0 | 2 (67) | 2 (67) |
≥6 | 1 (33) | 0 | 1 (33) |
Prior exposure to, n (%) | |||
Immunomodulatory agents | |||
Lenalidomide | 3 (100) | 3 (100) | 6 (100) |
Pomalidomide | 3 (100) | 3 (100) | 6 (100) |
PIs | |||
Bortezomib | 3 (100) | 3 (100) | 6 (100) |
Carfilzomib | 3 (100) | 3 (100) | 6 (100) |
Anti-CD38 mAb | |||
Daratumumab | 3 (100) | 3 (100) | 6 (100) |
Patient demographics and disease characteristics at screening for the mITT population, including all patients who received lete-cel.
mITT, modified ITT; N, patients in mITT population; n, patients with available data.
Eligible patients could have NY-ESO-1– and/or LAGE-1a–positive status.
Median time from diagnosis to screening is only provided for patients with complete diagnosis dates. Three patients had partial diagnosis dates and therefore were excluded from this row.
Patients could have more than 1 adverse cytogenetic feature.