A single-arm phase 2 study of talimogene laherparepvec in patients with lower-risk invasive cutaneous squamous cell cancer.

Abstract

Minimally invasive treatments are increasingly needed for low to intermediate risk cutaneous squamous cell carcinoma (cSCC), particularly in patients with high disease burden. To evaluate the efficacy and tolerability of intralesional talimogene laherparepvec (TVEC) as a novel immunotherapeutic approach for cSCC in patients seeking non-surgical options. Up to 5 histologically confirmed invasive low to intermediate risk cSCC tumors per patient were treated and referred to as target lesions injected (TLIs). Intralesional TVEC was administered every 2 weeks, up to 4 injections per lesion. Response rate was assessed by subject and individual TLIs. Eleven patients with 24 cSCC tumors were enrolled. ORR was 100% by patient (11/11) and by tumor (24/24) (95% CI = 76.2%). A confirmed complete response occurred in 90.9% of patients (10/11; 95% CI = 58.7%, 99.8%) involving 23 of 24 tumors. Median duration of response was 212 days (range = 140-236 days). Two years post-treatment, patients showed no recurrence and significantly fewer new primary invasive cSCCs. Nonrandomized, small sample size, and lesion site exclusions. Intralesional TVEC demonstrated promising efficacy and tolerability as a minimally invasive treatment for low to intermediate risk cSCC with potential to reduce subsequent incidence rates.