GenVec has begun a Phase II clinical study to evaluate the anticancer activity of TNFerade in patients with metastatic melanoma. The open-label, single-arm, multicenter study will assess tumor response after four weeks of intratumoral injections of TNFerade plus concomitant radiation therapy in 29 patients with Stage III or IV metastatic melanoma who are ineligible for curative surgery or unlikely to benefit from other treatment options. Patients will be evaluated two months after the completion of therapy and followed for three years thereafter.
In a Phase I trial in patients with solid tumors, three patients with Stage IV metastatic melanoma had complete local response and prolonged disease-free survival after local TNFerade lesion injection plus concomitant radiation; two of those patients remain disease-free approximately four years after treatment. This compares to the average survival rate of less than 2 years for patients with stage IV metastatic melanoma. Previous studies have demonstrated the ability of TNFerade to suppress the metastasis of melanoma into the lymph nodes in an animal model.