T-VEC Demonstrates Long-Term Efficacy in High-Risk Melanoma

Patients with advanced melanoma who receive talimogene laherparepvec (T-VEC) prior to surgery have better long-term outcomes than patients treated with surgery alone, according to a study published in JAMA Oncology.  

Researchers found that, at 5 years, patients who received T-VEC had superior relapse-free survival (RFS), event-free survival, and overall survival.

These results come from a phase 2 trial (ClinicalTrials.gov identifier: NCT02211131) of 150 patients with stage IIIB-IVM1a melanoma who had at least 1 injectable cutaneous, subcutaneous, or nodal lesion.

The patients were randomly assigned to undergo surgery alone (n=74) or with T-VEC (n=76). Patients in the T-VEC arm received 6 intralesional injections prior to surgery.

Adjuvant therapy was given at the investigator’s discretion. Patients in the surgery-alone arm were more likely than those in the T-VEC arm to receive adjuvant therapy (31.9% and 13.7%, respectively).

The median follow-up was 63.3 months. The 5-year RFS rate was 22.3% in the T-VEC arm and 15.2% in the surgery-alone arm (hazard ratio [HR], 0.76; 80% CI, 0.60-0.97).

There was no significant difference between the arms for local RFS (HR, 0.82; 80% CI, 0.64-1.06) or regional RFS (HR, 0.81; 80% CI, 0.62-1.05). However, distant metastasis-free survival was significantly better in the T-VEC arm than in the surgery-alone arm (HR, 0.73; 80% CI, 0.57-0.94).

The 5-year event-free survival rate was 43.7% in the T-VEC arm and 27.4% in the surgery-alone arm (HR, 0.57; 80% CI, 0.43-0.76). The 5-year overall survival rate was 77.3% in the T-VEC arm and 62.7% in the surgery-alone arm (HR, 0.54; 80% CI, 0.36-0.81).

“These results support further investigation of neoadjuvant T-VEC combined with checkpoint inhibitors for the treatment of resectable high-risk melanoma,” the researchers concluded.

Disclosures: This study was supported by Amgen. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

Reference

Dummer R, Gyorki DE, Hyngstrom JR, et al. Final 5-year follow-up results evaluating neoadjuvant talimogene laherparepvec plus surgery in advanced melanoma. A randomized clinical trial. JAMA Oncol. Published online August 10, 2023. doi:10.1001/jamaoncol.2023.2789

This article originally appeared on Cancer Therapy Advisor