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
Study Details
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.
Key Findings
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.
