Table 5.

Summary of oncolytic virus use in Phase III clinical trials.

Trial Name	Virus	Cancer	n	Central Questions and/or Outcomes
A Study of Talimogene Laherparepvec in stage IIIc and stage IV malignant melanoma [136] (Andtbacka 2015).	Talimogene Laherparepvec	Stage IIB-IV melanoma	295	T-VEC was compared to subcutaneous GM-CSF. Higher DRR at 6 months and greater median OS with T-VEC particularly in untreated advanced melanoma. Lesions that were not directly injected showed response. OS was not improved.
Phase IIIb safety results from an expanded-access protocol of talimogene laherparepvec for patients with unresected, stage IIIB-IVM1c melanoma [137] (Chesney 2018).	Talimogene Laherparepvec	Melanoma	41	Safety profile was consistent with previous trials. As compared to OPTIM trial above, this trial also included ECOG of 2 (OPTIM was 0, 1 only). Efficacy was not assessed, as the primary outcome was to provide expand access to T-VEC until FDA approval.

AE, adverse response; DRR, durable response rate; OS, overall survival.