Table 1.
Baseline patient demographics and clinical characteristics
| Characteristic | NIVO+RELA (n=50) |
| Median age (range), years | 60 (18‒80) |
| <65 | 34 (68) |
| ≥65 | 16 (32) |
| Sex | |
| Male | 28 (56) |
| Female | 22 (44) |
| Race | |
| White | 49 (98) |
| Black or African-American | 1 (2) |
| ECOG performance status | |
| 0 | 35 (70) |
| 1 | 15 (30) |
| Disease stage at diagnosis* | |
| I–III | 29 (58) |
| IV | 21 (42) |
| Primary tumor location | |
| Right colon | 34 (68) |
| Rectum | 6 (12) |
| Left colon | 4 (8) |
| Colon NOS | 3 (6) |
| Transverse colon | 1 (2) |
| Presence of liver metastases | |
| Yes | 18 (36) |
| No | 32 (64) |
| Clinical history of Lynch syndrome† | |
| Yes | 8 (16) |
| No | 16 (32) |
| Unknown | 26 (52) |
| Mutation status | |
| KRAS/BRAF wild type | 15 (30) |
| BRAF mutation | 12 (24) |
| KRAS mutation | 17 (34) |
| KRAS/BRAF mutation | 1 (2) |
| Unknown | 5 (10) |
| PD-L1 expression status | |
| ≥1% | 3 (6) |
| <1% | 24 (48) |
| Unknown | 23 (46) |
| LAG-3 expression status | |
| ≥1% | 8 (16) |
| <1% | 14 (28) |
| Unknown | 28 (76) |
| Neutrophil-to-lymphocyte ratio‡ | |
| <3 | 22 (44) |
| ≥3 | 28 (56) |
| Number of prior systemic regimens§,¶ | |
| 0 | 4 (8) |
| 1 | 11 (22) |
| 2 | 16 (32) |
| 3 | 15 (30) |
| ≥4 | 4 (8) |
| Regimen setting | |
| Adjuvant | 25 (50) |
| Metastatic disease | 40 (80) |
| Type of prior systemic therapy received | |
| 5-FU (fluorouracil, capecitabine) | 46 (92) |
| Oxaliplatin | 43 (86) |
| Irinotecan | 31 (62) |
| VEGF inhibitors (bevacizumab, aflibercept, ramucirumab) | 27 (54) |
| EGFR inhibitors (cetuximab, panitumumab) | 14 (28) |
| Regorafenib | 5 (10) |
| Other chemotherapy | 2 (4) |
| Primary reason for discontinuation of last prior systemic therapy | |
| Disease progression | 34 (68) |
| Drug toxicity | 9 (18) |
| Completed treatment | 2 (4) |
| Other** | 1 (2) |
Data are n (%) unless otherwise noted.
*All patients had stage IV disease at study entry.
†Lynch syndrome designation was based on the clinical records of patients at sites in countries where this reporting was permitted.
‡Neutrophil-to-lymphocyte ratio was derived by dividing absolute neutrophil count by absolute lymphocyte count.
§Some patients may have been treated with more than one type of therapy.
¶All four patients who received 0 prior systemic treatments for metastatic disease received adjuvant therapy and progressed within 6 months.
**Investigator discretion.
ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; LAG-3, lymphocyte-activation gene 3; NIVO, nivolumab; NOS, not otherwise specified; PD-L1, programmed death ligand 1; RELA, relatlimab; VEGF, vascular endothelial growth factor.