Table 1.
Characteristics at time of initial and rechallenge treatments.
| Initial treatment (n = 73) | Rechallenge treatment (n = 73) | |||
|---|---|---|---|---|
| Ipilimumab monotherapy (n = 32) | Ipilimumab + nivolumab (n = 41) | After initial ipilimumab monotherapy (n = 32) | After initial ipilimumab + nivolumab (n = 41) | |
| Age | ||||
| Mean (SD) | 56.9 (12.7) | 57.3 (14.6) | 61.3 (13.3) | 58.9 (14.6) |
| Gender | ||||
| Male | 20 (62.5%) | 24 (58.5%) | 20 (62.5%) | 24 (58.5%) |
| Female | 12 (37.5%) | 17 (41.5%) | 12 (37.5%) | 17 (41.5%) |
| ECOG PS | ||||
| 0 | 26 (86.7%) | 26 (70.3%) | 10 (37.0%) | 17 (51.5%) |
| 1 | 4 (13.3%) | 10 (27.0%) | 15 (55.6%) | 16 (48.5%) |
| 2 | – | 1 (2.7%) | 2 (7.4%) | – |
| No. missings | 2 | 4 | 5 | 8 |
| LDH level | ||||
| Normal | 28 (90.3%) | 21 (51.2%) | 16 (53.3%) | 24 (61.5%) |
| 1-2x elevated | 3 (9.7%) | 15 (36.6%) | 13 (43.3%) | 12 (30.8%) |
| >2x elevated | – | 5 (12.2%) | 1 (3.3%) | 3 (7.9%) |
| No. missings | 1 | – | 2 | 2 |
| Brain metastases | ||||
| No | 22 (75.9%) | 26 (63.4%) | 14 (53.8%) | 16 (42.1%) |
| Yes | 7 (24.1%) | 15 (36.6%) | 12 (46.2%) | 22 (57.9%) |
| Symptomatic | 1 (3.4%) | 5 (12.2%) | 5 (19.2%) | 8 (21.1%) |
| Asymptomatic | 4 (13.8%) | 10 (24.4%) | 4 (15.4%) | 13 (34.2%) |
| Unknown if symptomatic | 2 (6.9%) | – | 3 (11.5%) | 1 (2.6%) |
| No. missings | 3 | – | 6 | 3 |
| Liver metastases | ||||
| No | 23 (76.79%) | 25 (62.5%) | 24 (88.9%) | 30 (73.2%) |
| Yes | 7 (23.3%) | 15 (37.5%) | 3 (11.1%) | 11 (26.8%) |
| No. missings | 2 | 1 | 5 | - |
| BRAF V600 mutation | ||||
| No | 11 (40.7%) | 10 (25.0%) | 10 (37.0%) | 10 (24.4%) |
| Yes | 16 (59.3%) | 30 (75.0%) | 17 (63.0%) | 31 (75.6%) |
| No. missings | 5 | 1 | 5 | – |
| Intercurrent therapy | ||||
| BRAF/MEK inhibition | – | – | 14 (82.4%*) | 27 (87.1%*) |
| Anti-PD-1 | – | – | 15 (46.9%) | 10 (24.4%) |
| Other** | – | – | 6 (18.8%) | 3 (7.3%) |
| Best overall response | ||||
| CR | 5 (15.6%) | 3 (7.5%) | 5 (16.7%) | 6 (16.7%) |
| PR | 8 (25.0%) | 15 (37.5%) | 7 (23.3%) | 7 (19.4%) |
| SD | 9 (28.1%) | 8 (20.0%) | 2 (6.7%) | 2 (5.6%) |
| PD | 10 (31.3%) | 14 (35.0%) | 16 (53.3%) | 21 (58.3%) |
| No. missings | – | 1 | 2 | 5 |
| Toxicity grade ≥ 3 | ||||
| No | 24 (75.0%) | 22 (55.0%) | 19 (61.3%) | 22 (59.5%) |
| Yes | 8 (25.0%) | 18 (45.0%) | 12 (38.7%) | 15 (40.5%) |
| No. missings | – | 1 | 1 | 4 |
| Reason for stopping therapy | ||||
| Planned/completed | 24 (77.4%) | 4 (10.0%) | 3 (10.7%) | 2 (6.3%) |
| Progression | 4 (12.9%) | 13 (32.5%) | 7 (25.0%) | 19 (59.4%) |
| Toxicity | 3 (9.7%) | 21 (52.5%) | 11 (39.3%) | 8 (25.0%) |
| Patient condition | – | 1 (2.5%) | 6 (21.4%) | 2 (6.3%) |
| Death | – | – | – | 1 (3.1%) |
| Other | – | 1 (2.5%) | 1 (3.6%) | – |
| No. missings | 1 | 1 | 4 | 9 |
* Percentage calculated for patients with a known BRAFV600 mutation (n = 17 for initial ipilimumab monotherapy, n = 31 for initial ipilimumab + nivolumab)
** Other intercurrent therapies included nivolumab + anti-LAG-3 (n = 2), chemotherapy (n = 2), nivolumab + T-cells (n = 1), and high-dose IL2 (n = 1) after initial ipilimumab monotherapy, and nivolumab + anti-LAG-3 (n = 2) and TIL (n = 1) after initial ipilimumab+nivolumab.