Evaluating the effectiveness and safety of T-VEC plus surgery for the treatment of patients with resectable advanced stage melanoma.

This study compared the effectiveness and safety of talimogene laherparepvec (Imlygic; T-VEC) plus surgery versus surgery alone for the treatment of patients with resectable advanced stage (III or IV) melanoma. The data showed that T-VEC plus surgery was safe and effective for these patients.

Melanoma is an aggressive type of skin cancer. It has a high tendency to spread to other parts of the body (metastasis). The main form of treatment is the surgical removal of tumors. In stage III or IV melanoma, cancer has spread to nearby lymph nodes. These patients need additional therapy before surgery to shrink the cancer so that it can be completely removed by surgery (neoadjuvant therapy). Additional therapy options can include immunotherapy or targeted therapy.

T-VEC is a recently approved treatment for the treatment of unresectable (inoperable) advanced-stage melanoma. T-VEC is a genetically weakened herpes virus. This type of treatment specifically targets cancer cells, leaving healthy cells alone. When injected into a tumor, it splits the cancer cells open. This leads to cancer cell death. It has shown good effectiveness in unresectable melanoma. However, the effectiveness and safety of T-VEC plus surgery versus surgery alone for the treatment of patients with resectable stage III or IV melanoma are still unknown.

This study involved 150 patients with advanced-stage (III or IV) melanoma. Patients were randomly assigned into 2 groups. Group 1 included 76 patients who received T-VEC followed by surgery. Group 2 included 74 patients who received surgery alone. The average follow-up time for group 1 was 32.1 months and 30.9 months for group 2.

After 2 years, 88.9% of the patients in group 1 were alive compared to 77.4% of patients in group 2. Patients in group 1 were 51% more likely to have a better survival compared to group 2.

After 2 years, 29.5% of the patients in group 1 were alive without cancer recurrence compared to 16.5% of patients in group 2. Patients in group 1 were 25% more likely to have a better survival without cancer recurrence compared to group 2.

In group 1, 17.1% of patients achieved a pathological complete response (pCR; the absence of any cancer cells after surgery). 40.8% of the patients in group 2 had disease control (cancer gone or was not growing or spreading). The most common side effects of T-VEC were flu-like symptoms (fatigue, fevers, nausea).

This study concluded that T-VEC plus surgery was a safe and effective treatment for patients with resectable advanced-stage melanoma.

This study was funded by Amgen Inc, the manufacturers of T-VEC. This study had a small number of participants and a short follow-up period. Larger studies are needed.