Table 1.
Patient characteristics at baseline
| Cohort I (n=7) | Cohort II (n=21) | Cohort III (n=6) | P value* | ||
| Age mean (min-max) | 50.43 (33-67) | 54.24 (41-77) | 46.50 (36-56) | 0.24 | |
| Gender, n (%) | Male | 7 (100) | 14 (66.7) | 5 (83.3) | |
| Female | 0 (0) | 7 (33.3) | 1 (16.7) | ||
| LDH mean (min-max) | 234.3 (144–477) | 341.6 (136–973) | 279 (166–446) | 0.46 | |
| LDH level, n (%) | <250 | 5 (71.4) | 11 (52.4) | 2 (33.3) | |
| 250–500 | 2 (28.6) | 7 (33.3) | 4 (66.7) | ||
| >500 | 0 (0) | 3 (14.3) | 0 (0) | ||
| WHO, n (%) | 0 | 4 (57.1) | 12 (57.1) | 4 (66.7) | |
| 1 | 2 (28.6) | 7 (33.3) | 2 (33.3) | ||
| 2 | 0 (0) | 1 (4.8) | 0 (0) | ||
| Missing | 1 (14.3) | 1 (4.8) | 0 (0) | ||
| Brain metastasis (confirmed), n (%) | 5 (71.4) | 6 (28.6) | 1 (16.7) | 0.07 | |
| Pretreatment, n (%) | BRAFi/MEKi | 2 (28.6) | 8 (38.1) | 4 (66.7) | 0.34 |
| Anti-CTLA-4 only | 1 (14.3) | 1 (4.8) | 0 (0) | n.e. | |
| Anti-PD-1±anti-CTLA-4 | (0) | 12 (57.1) | 6 (100) | 0.001 | |
| Prior lines of systemic therapies, n (%) | 0–2 | 7 (100) | 14 (66.7) | 1 (16.7) | 0.007 |
| ≥3 | 0 (0) | 7 (33.3) | 5 (83.3) | ||
| TRT or TIL, n (%) | TRT | 6 (85.7) | 4 (19) | 0 (0) | 0.001 |
| TIL | 1 (14.3) | 17 (81) | 6 (100) | ||
| Responders†, n (%) | 1 (14.3) | 7 (33.3) | 2 (33.3) | ||
| CR | CR, PR, 5×SD | 2×SD | |||
*Statistically significant p values are indicated in bold, n.e.=not evaluable because n=2.
†Responders are defined by patients having CR, PR or SD.
CR, complete response; CTLA-4, cytotoxic T-lymphocyte-associated protein 4; LDH, lactate dehydrogenase; PD-1, programmed cell death protein 1; PR, partial response; SD, stable disease; TIL, tumor infiltrating T cells; TRT, tumor-reactive T cells.