Table 2

Study characteristics of included clinical studies of T-VEC

Clinical studyTreatmentTotal NType of cancerEfficacy measures*Risk of bias (/9)
Hu et al 14
Non-controlled
phase I
T-VEC30 (9 melanoma)Breast, colorectal, melanoma, head and neckCR: 0% (0%–14.1%)
PR: 0% (0%–14.1%)
7
Senzer et al 15
Non-controlled
phase II
T-VEC50MelanomaOR: 26.0% (15.1%–40.6%)
CR: 20.0% (10.5%–34.1%)
PR: 10.0% (3.7%–22.6%)
7
Harrington et al 18
phase I/II
T-VEC +cisplatin17Head and neckCR: 23.5% (7.8%–50.2%)
PR: 58.8% (33.5%–80.6%)
OR: 82.4% (55.8%–95.3%)
6
Chang et al 19
phase I
T-VEC17PancreaticOR: 0% (0%–22.9%)6
Andtbacka et al 13
phase III
T-VEC295MelanomaDR: 16.3% (12.1%–20.5%)
OR: 26.4% (21.4%–31.5%)
PR: 15.6% (11.7%–20.3%)
CR: 10.8% (7.6%–15.1%)
3
GM-CSF (control)141DR: 2.1% (0%–4.5%)
OR: 5.7% (1.9%–9.5%)
PR: 5.0% (1.3%–8.5%)
CR:<1%
Long et al 16
phase Ib
T-VEC +pembrolizumab21Melanoma6
Puzanov et al 17
phase Ib
T-VEC+IPI18MelanomaDR: 44.4% (22.4%–68.7%)
OR: 50.0% (29.0%–70.9%)
CR: 22.2% (7.4%–48.1%)
PR: 27.8% (10.7%–53.6%)
6
  • *Definitions of DR/OR/CR/PR were based on RECIST guidelines for clinical studies.

  • †Total number of domains that were assessed a score of high risk or unclear (maximum=9). The nine domains include randomisation, allocation concealment, blinding of participants/personnel, outcome assessment blinding, incomplete outcome reporting, selective outcome reporting, reported conflicts of interest, sample size calculation and funding.

  • CR, complete response/complete regression; DR, durable response; IPI, Ipilimumab; OR, objective response; PR, partial response; RECIST, Response Evaluation Criteria in Solid Tumours; T-VEC, talimogene laherparepvec.