Table 2.
HLA and MAGE-A10 expression, ADP-A2M10 dose and response in individual patients (ITT population) with NSCLC of various histologies at screening
| Patient ID | Age, years Sex |
Tumor histology | HLA-A, allele 1/ allele 2 | MAGE-A10 P-score,* % score <1+, 1+, 2+, 3+ | MAGE-A10 H-score† | Actual ADP-A2M10 dose, cells×109 | Response (DoSD‡) |
| 1 | 48 F |
AC | 01:01/02:01 | 70, 20, 10, 0 | 40 | 0.1 | PD |
| 2 | 72 M |
AC | 01:01/02:01 | 80, 0, 0, 20 | 60 | 0.1 | cPD |
| 3 | 46 M |
AC | 02:01/23:01 | 85, 5, 5, 5 | 30 | 0.1 | cPD |
| 4 | 60 M |
AC | 02:01/02:01 | 0, 10, 30, 60 | 250 | 0.1 | PD |
| 5 | 61 F |
SCC | 02:01/23:01 | 20, 20, 30, 30 | 170 | 0.1 | cPD |
| 6 | 53 F |
AC | 02:01/03:01 | 50, 20, 20, 10 | 90 | 1.2 | NE |
| 7 | 69 F |
SCC | 02:01/30:04 | 10, 30, 50, 10 | 160 | 1.2 | SD (58 days) |
| 8 | 69 M |
AC | 01:01/02:01 | 50, 45, 0, 5 | 60 | 0.67 | SD (89 days) |
| 9§ | 65 M |
SCC | 02:01/23:01 | 0, 5, 5, 90 | 285 | 6.01 5.23§ |
SD→PR§ SD (170 days) PR (32 days) |
| 10 | 63 M |
AC | 02:01/24:AUJRX | 75, 0, 0, 25 | 75 | 5.19 | SD (52 days) |
| 11 | 59 F |
AC | 02:01/68:01 | 40, 20, 10, 30 | 130 | 6.77 | SD (61 days) |
*P-score was IHC positivity determined by a pathologist on the basis of both percentage of positive tumor cells and intensity of expression.
†H-score was derived from the P-score by 1 × (% of 1+ cells) + 2 × (% of 2+ cells) + 3 × (% of 3+ cells).
‡DoSD was only analyzed in patients with SD.
§Patient 9 had a second ADP-A2M10 infusion after SD was demonstrated following the first infusion (see text for details).
AC, adenocarcinoma; cPD, clinical PD; DoSD, duration of SD; F, female; HLA, human leukocyte antigen; H-score, histoscore; ID, identifier; IHC, immunohistochemistry; ITT, intention-to-treat; M, male; MAGE-A10, melanoma-associated antigen A10; NE, not evaluable; NSCLC, non-small cell lung cancer; PD, progressive disease; PR, partial response; P-score, percent score; SCC, squamous cell carcinoma; SD, stable disease.