The final 5-year analysis of a phase II trial showed continued improvement in outcomes with the neoadjuvant addition of the intralesional oncolytic viral immunotherapy talimogene laherparepvec (T-VEC) to surgery in patients with advanced melanoma, according to a research letter published by Dummer et al in JAMA Oncology. Researchers randomly assigned 150 patients with advanced melanoma to receive six doses of neoadjuvant intralesional T-VEC followed by surgery (n = 76) or immediate surgery (n = 74). The primary analysis of the trial demonstrated a 2-year recurrence-free survival rate of 29.5% for patients in the T-VEC group vs 16.5% among those in the surgery alone group (hazard ratio [HR] = 0.75, 80% confidence interval [CI] = 0.58–0.96). After a median follow-up of 63.3 months, compared with those who received surgery alone, the patients who received T-VEC plus surgery experienced recurrence-free survival rates of 22.3% vs 15.2% (HR = 0.76, 80% CI = 0.60–0.97), event-free survival rates of 43.7% vs 27.4% (HR = 0.57, 80% CI = 0.43–0.76), and overall survival rates of 77.3% vs 62.7% (HR = 0.54, 80% CI = 0.36–0.81). Further, patients in the T-VEC plus surgery group had a median survival of 28.0 months vs 21.1 months among those in the surgery alone group. The study authors concluded: “These results demonstrate that neoadjuvant T-VEC plus surgery improves cancer-related outcomes vs surgery alone, with acceptable safety.”


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