Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Advanced Melanoma

The study aimed to assess the safety and efficacy of LTX-315 in combination with the immune checkpoint inhibitor (ICI) pembrolizumab in patients with advanced melanoma. LTX-315 has been administered with pembrolizumab in a previous Phase I/II study, and there were clear indications that LTX-315 + pembrolizumab was a clinically active combination. Furthermore, the addition of LTX-315 to pembrolizumab dosing did not appear to increase the overall incidence or severity profile of toxicities. The present study documented the preliminary efficacy, clinical safety, and tolerability of LTX-315 in combination with pembrolizumab, in a dose and regimen that is considered to be safe. Patient population consisted of patients with stage III B, C, D and Stage IVm1a, m1b unresectable metastatic melanoma with ECOG performance status of 0 or 1, who had received an FDA-approved anti-PD/PD-L1 therapy and had progressed after prior anti-PD-1 or anti-PD-L1 therapy, alone or in combination with systemic therapy.