Table 4.
Melanoma lesion characteristics at first administration of talimogene laherparepvec, at the lesion level and patient level
| Overall | Lesion levelb | Patient level | ||||
|---|---|---|---|---|---|---|
| Total lesions | Lesions injected with T-VEC | Lesions not injected with T-VEC | Total patients | Lesions injected with T-VEC | Lesions not injected with T-VEC | |
| (N = 558) | (N = 514) | (N = 44) | (N = 66) | (N = 66) | (N = 9) | |
| Cutaneous lesions, n (%)a | 279 (50.0) | 273 (53.1) | 6 (13.6) | 38 (57.6) | 38 (57.6) | 4 (44.4) |
| Head/neck | 6 (2.2) | 6 (2.2) | 0 | 2 (5.3) | 2 (5.3) | 0 |
| Trunk | 78 (28.0) | 77 (28.2) | 1 (16.7) | 10 (26.3) | 10 (26.3) | 1 (25.0) |
| Inguinal | 1 (0.4) | 1 (0.4) | 0 | 1 (2.6) | 1 (2.6) | 0 |
| Upper extremity | 18 (6.5) | 17 (6.2) | 1 (16.7) | 5 (13.2) | 4 (10.5) | 1 (25.0) |
| Lower extremity | 176 (63.1) | 172 (63.0) | 4 (66.7) | 27 (71.1) | 27 (71.1) | 2 (50.0) |
| Diameter of lesions (mm) | Number of lesions | |||||
| Mean (SD) | 4.6 (4.9) | 3.3 (–) | 4.6 (5.0) | 7.3 (6.7) | 7.2 (6.8) | 1.5 (1.0) |
| Median (IQR; range) | 3.0 (2, 5; 1–40) | 3.3 (–) | 3.0 (2, 5; 1–40) | 6.0 (2, 10; 1–30) | 5.5 (2, 10; 1–30) | 1.0 (1, 2; 1–3) |
| Subcutaneous lesions, n (%)a | 249 (44.6) | 217 (42.2) | 32 (72.7) | 35 (53.0) | 34 (51.5) | 4 (44.4) |
| Head/neck | 30 (12.0) | 30 (13.8) | 0 | 4 (11.4) | 4 (11.8) | 0 |
| Trunk | 26 (10.4) | 26 (12.0) | 0 | 3 (8.6) | 3 (8.8) | 0 |
| Inguinal | 0 | 0 | 0 | 0 | 0 | 0 |
| Upper extremity | 8 (3.2) | 8 (3.7) | 0 | 4 (11.4) | 4 (11.8) | 0 |
| Lower extremity | 185 (74.3) | 153 (70.5) | 32 (100) | 24 (68.6) | 23 (67.6) | 4 (100) |
| Diameter of lesions (mm) | Number of lesions | |||||
| Mean (SD) | 6.8 (8.2) | 6.9 (8.3) | 3.6 (3.3) | 7.1 (9.9) | 6.4 (7.4) | 8.0 (11.5) |
| Median (IQR; range) | 5 (3, 8; 1–60) | 5 (3, 8; 1–60) | 2.6 (1, 4.6; 1–10) | 3.0 (1, 8; 1–50) | 3.0 (1, 8; 1–27) | 3.0 (1, 15; 1–25) |
| Nodal lesions, n (%) a | 16 (2.9) | 13 (2.5) | 3 (6.8) | 6 (9.1) | 5 (7.6) | 2 (22.2) |
| Head/neck | 0 | 0 | 0 | 0 | 0 | 0 |
| Axillary | 5 (31.3) | 4 (30.8) | 1 (33.3) | 1 (16.7) | 1 (20.0) | 1 (50.0) |
| Cervical | 1 (6.3) | 1 (7.7) | 0 | 1 (16.7) | 1 (20.0) | 0 |
| Inguinal | 6 (37.5) | 4 (30.8) | 2 (66.7) | 3 (50.0) | 2 (40.0) | 1 (50.0) |
| Trunk | 1 (6.3) | 1 (7.7) | 0 | 1 (16.7) | 1 (20.0) | 0 |
| Upper extremity | 0 | 0 | 0 | 0 | 0 | 0 |
| Lower extremity | 2 (12.5) | 2 (15.4) | 0 | 1 (16.7) | 1 (20.0) | 0 |
| Other | 1 (6.3) | 1 (7.7) | 0 | 1 (16.7) | 1 (20.0) | 0 |
| Diameter of lesions (mm) | Number of lesions | |||||
| Mean (SD) | 10.7 (7.0) | 10.2 (7.0) | 18 (–) | 2.7 (1.4) | 2.6 (1.1) | 1.5 (0.7) |
| Median (IQR; range) | 9.5 (5, 17; 3–25) | 8.0 (5, 16.0; 3–25) | 18 (–) | 2.5 (2, 3; 1–5) | 3 (2, 3; 1–4) | 1.5 (1, 2; 1–2) |
IQR interquartile range, SD standard deviation, T-VEC talimogene laherparepvec
aSubjects can have lesions on multiple body sites
bNumber of subjects with evaluable data for lesion diameter