Table 1.
Baseline demographics and clinical characteristics.
| Talimogene laherparepvec | GM‐CSF | |
|---|---|---|
| No. of patients | N = 61 | N = 26 |
| Median (IQR) age, y | 70 (61–79) | 66 (58–75) |
| Men, no. (%) | 51 (84) | 17 (65) |
| ECOG PS, no. (%) | ||
| 0 | 43 (70) | 20 (77) |
| 1 | 18 (30) | 6 (23) |
| Disease stage at screening,a no. (%) | ||
| IIIB | 9 (15) | 5 (19) |
| IIIC | 17 (28) | 6 (23) |
| IVM1a | 11 (18) | 6 (23) |
| IVM1b | 15 (25) | 4 (15) |
| IVM1c | 9 (15) | 5 (19) |
| Elevated LDH, no. (%) | 2 (3) | 1 (4) |
| BRAF status,b no. (%) | ||
| Mutant | 10 (16) | 6 (23) |
| Wild‐type | 6 (10) | 4 (15) |
| Unknown/missing | 45 (74) | 16 (62) |
| Location of first recurrence,c no. (%) | ||
| Surgical scar (local) | 17 (28) | 4 (15) |
| In‐transit/satellitosis | 21 (34) | 7 (27) |
| Regional lymph node(s) | 16 (26) | 3 (12) |
| Distant skin site | 7 (11) | 6 (23) |
| Distant lymph node(s) | 0 | 1 (4) |
| Visceral | 3 (5) | 2 (8) |
| Other | 4 (7) | 4 (15) |
| Missing | 3 (5) | 2 (8) |
| Median (IQR) time from initial diagnosis to first recurrence, y | 0.6 (0.3–1.2) | 0.5 (0.3–1.6) |
| Line of therapy, no. (%) | ||
| First line | 37 (61) | 15 (58) |
| Second line or greater | 24 (39) | 11 (42) |
| HSV‐1 status, no. (%) | ||
| Seropositive | 38 (62) | 13 (50) |
| Seronegative | 18 (30) | 13 (50) |
| Unknown | 5 (8) | 0 |
Abbreviations: GM‐CSF, granulocyte‐macrophage colony‐stimulating factor; IQR, interquartile range; ECOG PS, Eastern Cooperative Oncology Group performance status; LDH, lactate dehydrogenase; HSV‐1, herpes simplex virus type 1.
a
Per case report form at screening.
b
Because tissue was not collected prospectively, BRAF mutation analysis was reported by investigators and not evaluated centrally.
c
Patients may have had more than one site of first recurrence. Site of first recurrence was evaluated at screening.