TABLE 1.
Summary of patient characteristics stratified on dose, presented as mean (standard deviation) [minimum; maximum] {number of subjects missing} or number of subjects (%).
| Baseline characteristics | 500 mg | 1200 mg |
|---|---|---|
| (n = 40) | (n = 40) | |
| Age (years) | 63.9 (8.9) | 62.1 (11.1) |
| [43.0; 85.0] | [38.0; 79.0] | |
| Body weight (kg) |
68.0 (15.6) [41.9; 109.0] |
70.8 (13.8) [44.3; 107.8] |
| Sex | ||
| Female | 16 (40%) | 7 (18%) |
| Male | 24 (60%) | 33 (82%) |
| Race | ||
| White | 25 (62%) | 14 (35%) |
| Black/African Americans | 0 (0%) | 1 (3%) |
| Asian | 15 (38%) | 25 (62%) |
| Smoking status | ||
| Never used | 13 (32%) | 5 (12%) |
| Former/regular | 27 (68%) | 35 (88%) |
| C‐reactive protein (mg/L) |
27.1 (26.7) [1.0; 88.2] {3} |
30.8 (70.0) [0.4; 429.1] |
| Lactate dehydrogenase (U/L) |
327.2 (152.9) [80.0; 769.0] {1} |
301.3 (202.5) [144.0; 1259.0] {1} |
| Neutrophil‐to‐lymphocyte ratio | 4.1 (1.9) | 3.7 (2.4) |
| [0.9; 9.1] | [1.6; 14.0] | |
| TGF‐β1 plasma concentration (ng/L) |
7058.3 (10,101.9) [625.0; 32,904.2] {7} |
6254.4 (13,832.8) [625.0; 77,104.5] {1} |
| PD‐L1 tumor cell expression (%) | 35.6 (29.6) | 37.5 (31.3) |
| [2.0; 100.0] {2} | [0.0; 95.0] {3} | |
| ECOG score | ||
| 0 | 13 (32%) | 7 (18%) |
| 1 | 27 (68%) | 33 (82%) |
| >1 | 0 (0%) | 0 (0%) |
| Metastases | ||
| Yes | 33 (82%) | 32 (80%) |
| No | 7 (18%) | 8 (20%) |
| Liver metastases | ||
| Yes | 7 (18%) | 4 (10%) |
| No | 33 (82%) | 36 (90%) |
| Number of non‐target lesions |
5.2 (2.5) [1.0; 11.0] |
4.5 (2.3) [1.0; 10.0] |
| Histology | ||
| Non‐squamous | 32 (80%) | 31 (78%) |
| Squamous | 8 (20%) | 9 (22%) |
| Previous medication with biologics a | ||
| Yes | 7 (18%) | 9 (22%) |
| No | 33 (82%) | 31 (78%) |
| Previous medication with antibiotics b | ||
| Yes | 14 (35%) | 11 (28%) |
| No | 26 (65%) | 29 (72%) |
| Concomitant corticosteroids | ||
| Yes | 20 (50%) | 23 (58%) |
| No | 20 (50%) | 17 (42%) |
Abbreviation: ECOG, Eastern Cooperative Oncology Group.
a
Biologics treatment received prior to therapy with bintrafusp alfa.
b
Systemic antibacterial medication received at any time in the period from 1 month (29 days) before until 1 month (29 days) after randomization for any duration.