Table 3.

Analysis of survival outcomes.

Variable	Vaccine-Related Time-to-Treatment Failure				Overall Survival
	Univariate Analysis		Multivariate Analysis		Univariate Analysis		Multivariate Analysis
	Median V-TTF (95% CI), Months	p Value	HR (95% CI)	p Value	Median OS (95% CI), Months	p Value	HR (95% CI)	p Value
Cancer type		0.002		0.091		<0.001		0.019
- others	19.0 (10.5–27.5)		1.00		38.0 (27.5-NR)		1.00
- lung	2.7 (1.8–3.6)		1.96 (0.89–4.29)		14.9 (11.4–18.3)		4.18 (1.26–13.86)
Number of metastatic sites		<0.001		0.007		<0.001		0.14
- 1	19.4 (10.5–28.2)		1.00		26.2 (23.8-NR)		1.00
- ≥2	2.7 (1.7–3.7)		3.08 (1.36–6.99)		14.7 (12.4–17.0)		2.37 (0.73–7.63)
Bone metastases		0.001		0.47		0.002		0.50
- not present	9.4 (0.1–9.3)		1.00		56.2 (21.8–90.6)		1.00
- any	2.3 (0.4–4.2)		1.30 (0.63–2.68)		14.8 (11.5–18.1)		1.31 (0.58–2.93)
Weight loss a		<0.001		0.47		<0.001		0.83
- <10%	9.4 (3.7–15.1)		1.00		53.8 (27.2–80.4)		1.00
- ≥10%	2.0 (1.0–3.1)		1.34 (0.60–2.98)		13.7 (10.7–16.7)		1.09 (0.46–2.58)
PD-L1 TPS		0.001		0.47		<0.001		0.015
- <1% or unknown	2.5 (1.0–3.9)		1.00		12.4 (10.3–14.5)		1.00
- ≥1%	9.8 (2.3–17.3)		0.76 (0.37–1.59)		56.2 (31.7–80.7)		0.34 (0.14–0.81)
NK cell level b		<0.001		0.014		<0.001		0.027
- low-responders	2.4 (1.8–2.9)		1.00		12.0 (8.1–15.8)		1.00
- high-responders	14.0 (1.8–26.2)		0.34 (0.14–0.80)		56.8 (29.6–78.0)		0.36 (0.15–0.89)

HR—hazard ratio; CI—confidence interval; PD-L1 TPS—programmed cell death-ligand 1 tumor proportion score; NR—not reached; ^a weight loss indicates body weight variation in the 90 days preceding the third dose of tozinameran; ^b 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.