Treatment and response overview
| Treatment overview | All | Non-disease control | Disease control | P value |
| TIL succes rates, n | ||||
| TIL products/tumor resections | 30/34 | |||
| TIL products/enrolled patients | 30/31 | |||
| TIL-treated patients | 25 | 17 | 8 | |
| TIL production, median (min–max) | ||||
| Young TIL expansion (days) | 23 (15–44) | 26 (18–44) | 20 (15–28) | n.s. |
| Resection to TIL infusion (days) | 44 (34–197) | 49 (34–197) | 43 (36–62) | n.s. |
| Cells in infusion product (10e9) | 61.2 (5–126) | 57 (5–126) | 67 (53–109) | n.s. |
| REP fold exp. | 2840 (265–6300) | 2605 (265–6300) | 3340 (2660–4748) | n.s. |
| TIL product (REP TILs), median (min–max) | ||||
| CD3+ of live cells (%) | 97.4 (91.1–98.8) | 97.3 (91.1-98-8) | 97.5 (94.2–98.8) | n.s. |
| CD4+ of CD3+ (%) | 56.5 (2.2–95.4) | 56.5 (2.2–95.4) | 55.6 (4.7–87.0) | n.s. |
| CD8+ of CD3+ (%) | 31.9 (1.5–79.3) | 31.9 (1.5–71.7) | 37.2 (7.2–79.3) | n.s. |
| Performance status at day −8 | ||||
| 0 | 18 | 12 | 6 | |
| 1 | 4 | 2 | 2 | |
| 2 | 3 | 3 | 0 | |
| IL-2 doses, n | ||||
| 0 | 2 | 2 | 0 | |
| 1–9 | 8 | 7 | 1 | 0.025 |
| 10–14 | 15 | 7 | 6 | |
| Nivolumab doses, n | ||||
| 1–2 | 5 | 5 | 0 | 0.001 |
| 3–4 | 20 | 11 | 9 | |
| Objective response | ||||
| PR | 2 | 0 | 2 | |
| SD | 19 | 13 | 6 | |
| PD | 4 | 4 | 0 |
Summary of the TIL expansions and 25 treated patients. Patients were divided in disease control (PR or stable disease >4.5 months) and non-disease control groups depending on their objective response and its duration. Objective responses were assessed according to RECIST V.1.1.
n.s., not significant; PR, partial response; REP, rapid expansion protocol; SD, stable disease; TIL, tumor-infiltrating lymphocyte.