Table 2.
Characteristics of patients treated with talimogene laherparepvec in OPTiM by complete response and partial response (per investigator assessment)a
| Characteristic | Complete response (n = 50) | Partial response (n = 43) |
|---|---|---|
| Median (IQR) age, years | 70 (60–78) | 63 (53–77) |
| Female | 20 (40) | 21 (49) |
| ECOG performance status = 0 | 42 (84) | 31 (72) |
| AJCC stage | ||
| IIIB/C | 31 (62) | 15 (35) |
| IVM1a | 15 (30) | 14 (33) |
| IIIB–IVM1a | 46 (92) | 29 (67) |
| IVM1b | 2 (4) | 7 (16) |
| IVM1c | 2 (4) | 7 (16) |
| In-transit or distant skin metastases | ||
| IIIB–IVM1a | 42 (84) | 20 (47) |
| IIIB–IVM1c | 44 (88) | 26 (60) |
| Elevated LDH (>ULN) | 0 | 0 |
| Line of treatment | ||
| 1st | 33 (66) | 27 (63) |
| ≥ 2nd | 17 (34) | 16 (37) |
| Median baseline tumor burden (range), cm2 | 4.6 (0.3–38.3) | 10.9 (0.6–280.6) |
| BRAF status | ||
| Mutation | 5 (10) | 9 (21) |
| Wild type | 5 (10) | 9 (21) |
| Unknown/missing | 40 (80) | 25 (58) |
| HSV-1 seropositive at baseline | 32 (64) | 28 (65) |
Data presented are number (%) of patients, unless otherwise indicated
aAmong 295 patients randomized to talimogene laherparepvec, 291 received treatment and 287 were evaluable for response assessment per investigator assessment
AJCC American Joint Committee on Cancer, ECOG Eastern Cooperative Oncology Group, HSV herpes simplex virus, IQR interquartile range, LDH lactate dehydrogenase, ULN upper limit of normal