As reported in a research letter in JAMA Oncology by Reinhard Dummer, MD, and colleagues, the final, 5-year analysis of a phase II trial showed continued improvement in outcomes with the addition of neoadjuvant talimogene laherparepvec (T-VEC) to surgery in patients with advanced melanoma.
Reinhard Dummer, MD
In the open-label trial, 150 patients from sites in nine countries were randomly assigned beginning in February 2015 to receive six doses of neoadjuvant intralesional T-VEC followed by surgery (n = 76) or immediate surgery (n = 74). The primary analysis of the study showed a 2-year recurrence-free survival rate of 29.5% in the T-VEC/surgery group vs 16.5% in the surgery group (hazard ratio [HR] = 0.75, 80% confidence interval [CI] = 0.58–0.96).
The benefit persisted at 3 years (HR = 0.74, 80% CI = 0.57–0.95). The current analysis provides findings at 5 years.
Median follow-up at the time of analysis was 63.3 months (range = 0.1–86.8 months). Estimated 5-year rates for the T-VEC/surgery group vs the surgery-alone group follow: 22.3% vs 15.2% for recurrence-free survival (HR = 0.76, 80% CI = 0.60–0.97); 43.7% vs 27.4% for event-free survival (HR = 0.57, 80% CI = 0.43–0.76); and 77.3% vs 62.7% for overall survival (HR = 0.54, 80% CI = 0.36–0.81).
Median survival durations were 28.0 vs 21.1 months for local recurrence–free survival (HR = 0.82, 80% CI = 0.64–1.06); 32.9 vs 24.7 months for regional recurrence–free survival (HR = 0.81, 80% CI = 0.62–1.05); and 27.6 vs 15.0 months for distant metastasis–free survival (HR = 0.73, 80% CI = 0.57–0.94).
The investigators stated: “In this analysis, we report durable improvements in 5-year [recurrence-free survival, event-free survival, distant metastasis–free survival, and overall survival] with neoadjuvant T-VEC plus surgery over standard surgery. These results demonstrate that neoadjuvant T-VEC plus surgery improves cancer-related outcomes vs surgery alone, with acceptable safety.”
Dr. Dummer, of the University Hospital of Zurich, Switzerland, is the corresponding author of the JAMA Oncology article.
Disclosure: The study was funded by Amgen. For full disclosures of the study authors, visit jamanetwork.com.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.