Table 2.
Analysis of clinical benefit outcome.
| Univariate Analysis | Multivariate Analysis | ||||
|---|---|---|---|---|---|
| NCB N = 30 (100%) |
DCB N = 26 (100%) |
p Value | OR (95% CI) | p Value | |
| Age | 0.99 | - | - | ||
| - ≤70 years (N = 32) | 17 (56.7%) | 15 (57.7%) | |||
| - >70 years (N = 24) | 13 (43.3%) | 11 (42.3%) | |||
| Sex | 0.55 | - | - | ||
| - female (N = 16) | 10 (33.3%) | 6 (23.1%) | |||
| - male (N = 40) | 20 (66.7%) | 20 (76.9%) | |||
| ECOG PS | 0.25 | - | - | ||
| - 0 (N = 17) | 7 (23.3%) | 10 (38.5%) | |||
| - 1 (N = 39) | 23 (76.7%) | 16 (61.5%) | |||
| Cancer type | 0.005 † | 0.16 | |||
| - any other (N = 19) | 5 (16.7%) | 14 (53.8%) | 1.00 | ||
| - lung (N = 37) | 25 (83.3%) | 12 (46.2%) | 0.25 (0.03–1.71) | ||
| Number of metastatic sites | <0.001 † | 0.026 | |||
| - 1 (N = 23) | 4 (13.3%) | 19 (73.1%) | 1.00 | ||
| - ≥2 (N = 33) | 26 (86.7%) | 7 (26.9%) | 0.10 (0.01–0.76) | ||
| Brain metastases | 0.34 | - | - | ||
| - not present (N = 44) | 22 (73.3%) | 22 (84.6%) | |||
| - any (N = 12) | 8 (26.7%) | 4 (15.4%) | |||
| Bone metastases | 0.008 † | 0.66 | |||
| - not present (N = 39) | 16 (53.3%) | 23 (88.5%) | 1.00 | ||
| - any (N = 17) | 14 (46.7%) | 3 (11.5%) | 0.68 (0.12–3.85) | ||
| Liver metastases | 0.025 | - | - | ||
| - not present (N = 50) | 24 (80.0%) | 26 (100%) | |||
| - any (N = 6) | 6 (20.0%) | - | |||
| Weight loss a | 0.001 † | 0.28 | |||
| - <10% (N = 39) | 15 (50.0%) | 24 (92.3%) | 1.00 | ||
| - ≥10% (N = 17) | 15 (50.0%) | 2 (7.7%) | 0.31 (0.03–2.65) | ||
| PD-L1 TPS | <0.001 † | 0.010 | |||
| - <1% or unknown (N = 22) | 20 (66.7%) | 2 (7.7%) | 1.00 | ||
| - >1% (N = 34) | 10 (33.3%) | 24 (92.3%) | 13.29 (1.86–94) | ||
| Treatment setting | 0.26 | - | - | ||
| - first line (N = 36) | 17 (56.7%) | 19 (73.1%) | |||
| - second or later line (N = 20) | 13 (43.3%) | 7 (26.9%) | |||
| Corticosteroid therapy b | 0.34 | - | - | ||
| - no (N = 44) | 22 (73.3%) | 22 (84.6%) | |||
| - yes (N = 12) | 8 (26.7%) | 4 (15.4%) | |||
| ICI therapy | 0.48 | - | - | ||
| - anti-PD-1 (N = 47) | 24 (80.0%) | 23 (88.5%) | |||
| - anti-PD-L1 (N = 9) | 6 (20.0%) | 3 (11.5%) | |||
| Treatment type | 0.14 | - | - | ||
| - ICI monotherapy | 18 (60.0%) | 21 (80.8%) | |||
| - ICI and chemotherapy | 12 (40.0%) | 5 (19.2%) | |||
| NK cell level c | <0.001 † | 0.020 | |||
| - low-responders (N = 24) | 21 (70.0%) | 3 (11.5%) | 1.00 | ||
| - high-responders (N = 32) | 9 (30.0%) | 23 (88.5%) | 12.31 (1.48–102) | ||
NCB—no clinical benefit; DCB—durable clinical benefit; OR—odds ratio; CI—confidence interval; ECOG PS—Eastern Cooperative Oncology Group Performance Status; PD-L1 TPS—programmed cell death-ligand 1 tumor proportion score; ICI—immune checkpoint inhibitor. a weight loss indicates body weight change during 90 days before the third dose of tozinameran; b corticosteroid therapy indicates ≥ 10 mg prednisone equivalent daily for at least 7 days during 28 days before the third dose of tozinameran; c low-responders indicate the subgroup of patients with NK cell count < 222/µL after the third dose of tozinameran, high-responders indicate the subgroup of patients with NK cell count ≥ 222/µL after the third dose of tozinameran; † statistical significance maintained after Holm–Bonferroni p value correction for multiple comparisons.