Table 2.
Patient and sample incidence of T-VEC DNA during cycles 1–4.
Patient incidence of T-VEC DNA |
Sample incidence of T-VEC DNA |
|||||
---|---|---|---|---|---|---|
Baseline HSV-1 seronegative |
Baseline HSV-1 seropositive |
Overall |
Baseline HSV-1 seronegative |
Baseline HSV-1 seropositive |
Overall |
|
N = 17 |
N = 40 |
N = 60 |
n3/n4 (%) |
n3/n4 (%) |
n3/n4 (%) |
|
n1/n2 (%) | n1/n2 (%) | n1/n2 (%) | ||||
Blood | 17/17 (100·0) | 39/40 (97·5) | 59/60 (98·3) | 136/297 (45.8) | 234/693 (33.8) | 383/1043 (36.7) |
Urine | 5/17 (29·4) | 14/40 (35·0) | 19/60 (31·7) | 9/294 (3.1) | 22/694 (3·2) | 31/1041 (3·0) |
Surface of injected lesions | 17/17 (100·0) | 40/40 (100·0) | 60/60 (100·0) | 165/307 (53·7) | 507/885 (57·3) | 726/1260 (57·6) |
Exterior of occlusive dressings | 13/17 (76·5) | 33/40 (82·5) | 48/60 (80·0) | 51/289 (17·6) | 145/741 (19·6) | 212/1085 (19·5) |
Oral mucosa | 3/17 (17·6) | 1/40 (2·5) | 5/60 (8·3) | 7/105 (6.7) | 1/237 (0·4) | 9/359 (2·5) |
Anogenital area | 0/7 (0·0) | 2/16 (12·5) | 2/25 (8·0) | 0/53 (0·0) | 2/121 (1·7) | 2/190 (1·1) |
N = Number of patients in the analysis set; n1 = number of patients with positive qPCR testing result; n2 = number of patients with samples collected; n3 = number of samples with positive qPCR testing result; n4 = number of samples collected.
Abbreviations: HSV, herpes simplex virus; qPCR, quantitative polymerase chain reaction; T-VEC, talimogene laherparepvec.