. 2021 Mar 30;9(3):e001621. doi: 10.1136/jitc-2020-001621

Table 3.

Relationship between CD8⁺ T-cell density at baseline/during treatment and efficacy endpoints following treatment with talimogene laherparepvec

	OR/HR (95% CI) or correlation coefficient; p value
	Primary analysis (median follow-up 59 weeks)	Longer-term analysis (median follow-up 108 weeks)
Association between log₂(baseline CD8⁺ T-cell density) and efficacy endpoints
Baseline CD8⁺ and objective response rate*†‡	1.11 (0.87 to 1.42); p=0.387	1.06 (0.84 to 1.34); p=0.621
Baseline CD8⁺ and durable response rate†‡	1.40 (0.99 to 1.97); p=0.056	1.18 (0.91 to 1.53); p=0.222
Baseline CD8⁺ and disease control rate†‡	1.09 (0.87 to 1.37); p=0.436	1.09 (0.88 to 1.35); p=0.451
Baseline CD8⁺ and duration of response§¶	0.74 (0.39 to 1.37); p=0.335	0.84 (0.56 to 1.27); p=0.415
Baseline CD8⁺ and change in tumor burden**	r=0.03 (n=82); p=0.82	r=0.01 (n=84); p=0.94
Baseline CD8⁺ and overall survival‡§	1.15 (0.92 to 1.43); p=0.217	1.06 (0.89 to 1.25); p=0.539
Baseline CD8⁺ and time to treatment failure‡§	0.94 (0.82 to 1.08); p=0.399	0.94 (0.82 to 1.07); p=0.336
Association between change in log₂(CD8⁺ T-cell density) and efficacy endpoints
Change in CD8⁺ and objective response rate†††	0.94 (0.72 to 1.24); p=0.660	1.01 (0.78 to 1.31); p=0.962
Change in CD8⁺ and durable response rate†††	0.99 (0.69 to 1.44); p=0.974	0.93 (0.68 to 1.25); p=0.612
Change in CD8⁺ and disease control rate†††	1.08 (0.84 to 1.38); p=0.551	1.11 (0.87 to 1.41); p=0.386
Change in CD8⁺ and duration of response‡‡‡	1.28 (0.47 to 3.47); p=0.626	1.22 (0.76 to 1.95); p=0.406
Change in CD8⁺ and change in tumor burden**	r=−0.18 (n=56); p=0.18	r=−0.19 (n=60); p=0.14
Change in CD8⁺ and overall survival§††	0.85 (0.66 to 1.08); p=0.187	0.89 (0.75 to 1.06); p=0.188
Change in CD8⁺ and time to treatment failure§††	0.94 (0.81 to 1.09); p=0.412	0.97 (0.85 to 1.11); p=0.680

*Primary endpoint of study.

†A logistic regression model for objective response rate and durable response rate was performed for baseline/change from baseline intratumoral CD8⁺ T-cell density to obtain unadjusted OR.

‡Analysis conducted in biomarker analysis set, n=91.

§A Cox proportional-hazards regression model for duration of response, overall survival and time to treatment failure was performed for baseline/change from baseline intratumoral CD8⁺ T-cell density to obtain unadjusted HR.

¶Analysis conducted in responders who had CD8⁺ density recorded at baseline: primary analysis n=27, longer-term analysis n=28.

**Pearson’s correlation coefficient (r) was estimated to assess the relationship between log₂(CD8⁺ T-cell density) or change in log₂(CD8⁺ T-cell density) and the maximum decrease in measurable tumor burden.

††Analysis conducted in biomarker evaluable analysis set for non-injected lesions: primary analysis n=59, longer-term analysis n=63.

‡‡Analysis conducted in responders in the biomarker analysis set who had CD8⁺ density recorded at baseline and week 6: primary analysis n=16, longer-term analysis n=17.

CI, confidence interval; HR, hazard ratio; OR, odds ratio.