Survival, safety, and response patterns in a phase 1b multicenter trial of talimogene laherparepvec (T-VEC) and ipilimumab (ipi) in previously untreated, unresected stage IIIB-IV melanoma.

9063 Background: T-VEC is an HSV-derived oncolytic immunotherapy designed to induce systemic antitumor immunity. In a phase 3 melanoma study, T-VEC monotherapy significantly improved durable response rate (DRR, ≥ 6 month response) vs GM-CSF (16% vs 2%, P < 0.0001; Andtbacka et al. ASCO 2013), and median OS was 4.4 months longer for T-VEC vs GM-CSF (23.3 vs 18.9 months; HR = 0.79, 95% CI: 0.62-1.00; P= 0.051; Kaufman et al, ASCO 2014). Combining T-VEC to promote tumor-derived antigen release with an immune checkpoint inhibitor may enhance efficacy compared to either agent alone. The phase 1b portion of this phase 1b/2 combination study (NCT01740297) completed enrollment and met its primary objective with no dose-limiting toxicities (DLTs) and an objective response rate (ORR) of 56% (Puzanov et al. ASCO 2014). Methods: Key inclusion criteria included stage IIIB-IV melanoma; no prior systemic treatment; measurable disease; and ≥ 1 injectable cutaneous, subcutaneous, or nodal lesion. T-VEC was given intralesi...