A single-arm phase 2 study of talimogene laherparepvec in patients with lower-risk invasive cutaneous squamous cell cancer
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: BACKGROUND: Minimally invasive treatments are increasingly needed for low to intermediate risk cutaneous squamous cell carcinoma (cSCC), particularly in patients with high disease burden. OBJECTIVE: To evaluate the efficacy and tolerability of intralesional talimogene laherparepvec (TVEC) as a novel immunotherapeutic approach for cSCC in patients seeking non-surgical options. METHODS: 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. RESULTS: 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. LIMITATIONS: Nonrandomized, small sample size, and lesion site exclusions. CONCLUSION: 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.
Authors: Delaney Bake Stratton, Anngela Christina Adams, Srinath Sundararajan, Haiyan Cui, Denise J. Roe, Clara Curiel-Lewandrowski
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,200
Funder: Amgen
OpenAlex ID: W4416265448