Table 1.
Patient baseline demographics and clinical characteristics
| Talimogene laherparepvec (N=111) | |
| Age | |
| Median (range), years | 68 (26–90) |
| <50 years, n (%) | 19 (17.1) |
| ≥50 years, n (%) | 92 (82.9) |
| ≥75 years, n (%) | 38 (34.2) |
| Sex, n (%) | |
| Male | 49 (44.1) |
| Female | 62 (55.9) |
| Race, n (%) | |
| Caucasian | 111 (100) |
| ECOG PS 0/1, n (%) | 87 (78.4)/24 (21.6) |
| Stage of melanoma, n (%) | |
| IIIB | 14 (12.6) |
| IIIC | 32 (28.8) |
| IVM1a | 38 (34.2) |
| IIIB-IVM1a | 84 (75.7) |
| IVM1b | 15 (13.5) |
| IVM1c | 12 (10.8) |
| BRAF status, n (%) | |
| Mutation (V600E or V600K) | 37 (33.3) |
| Wild-type | 73 (65.8) |
| Missing/unknown | 1 (0.9) |
| Baseline LDH, n (%) | |
| ≤ULN | 84 (75.7) |
| >ULN | 27 (24.3) |
| Baseline HSV status, n (%) | |
| Positive | 88 (79.3) |
| Negative | 17 (15.3) |
| Equivocal | 1 (0.9) |
| Unknown | 5 (4.5) |
| Prior surgical procedures*, n (%) | |
| Yes | 108 (97.3) |
| No | 3 (2.7) |
| Prior anticancer therapy, n (%) | |
| Yes | 58 (52.3) |
| No | 53 (47.7) |
| Type of prior therapy, n (%) | |
| Immunotherapy† | 40 (36.0) |
| Chemotherapy | 18 (16.2) |
| External beam radiotherapy | 10 (9.0) |
| Targeted biologics‡ | 4 (3.6) |
| Targeted small molecules§ | 7 (6.3) |
| Other¶ | 19 (17.1) |
*The most frequently reported surgical procedures were tumor excision (73.0%) and excisional biopsy (55.0%).
†Most common class of immunotherapy was immune checkpoint inhibitors (ipilimumab n=22; pembrolizumab n=7; nivolumab n=9).
‡Interferon.
§Targeted small molecules include dabrafenib, vemurafenib, cobimetinib and imatinib.
¶Includes radiotherapy, topical therapy, clinical trial, cryotherapy, electrochemotherapy, protein kinase inhibitor, radical teleradiotherapy, chemoimmunotherapy, electrochemotherapy.
BRAF, v-raf murine sarcoma viral oncogene homolog B1; ECOG PS, Eastern Cooperative Oncology Group performance status; LDH, lactate dehydrogenase; HSV, herpes simplex virus; ULN, upper limit of normal.