Table 1. Cohort characteristics.
| Arm A* | Arm B | Arm C | |
| (N=36) | (N=17) | (N=22) | |
| Age (years) | |||
| Mean (SD) | 65.6 (8.10) | 65.2 (9.63) | 65.5 (8.02) |
| Median (Min, Max) | 67.0 (44.0, 80.0) | 66.0 (41.0, 83.0) | 65.0 (53.0, 81.0) |
| Race | |||
| Black or African American | 5 (13.9%) | 4 (23.5%) | 3 (13.6%) |
| White | 31 (86.1%) | 13 (76.5%) | 19 (86.4%) |
| irAE‡ during the first 180 days | |||
| Yes | 24 (66.7%) | 1 (5.9%) | 17 (77.3%) |
| No | 12 (33.3%) | 16 (94.1%) | 5 (22.7%) |
| Prior IO | |||
| No prior IO | – | – | 10 (45.5%) |
| Prior IO | – | – | 12 (54.5%) |
| Carcinosarcoma | |||
| Yes | – | – | 11 (50%) |
| No | – | – | 11 (50%) |
| TCGA category | |||
| CN-H | 7 (19.4%) | 5 (29.4%) | 5 (22.7%) |
| CN-L | 10 (27.8%) | 4 (23.5%) | 5 (22.7%) |
| MSI+POLE† | 2 (5.6%) | 1 (5.9%) | 5 (22.7%) |
| Unknown | 17 (47.2%) | 7 (41.2%) | 7 (31.8%) |
*
One patient in Arm A did was lost to follow-up and not evaluable for response, therefore has not been included in survival analysis.
†
All MSI+POLE positive patients in Arm C were previously exposed to IO treatment. Two of these patients were POLE-mutated and had carcinosarcoma histology.
‡
irAE are immune-related adverse events
CN-Hcopy number highCN-Lcopy number lowIOimmuno-oncology MSImicrosatellite instabilityTCGAThe Cancer Genome Atlas