Melanoma Vaccine OncoVEX enters Phase III Clinical Trial
Researchers have found a melanoma vaccine that has had promising results. A clinical trial is underway and is in Phase III after positive findings from the first two trials. The vaccine, OncoVEX has lead to complete recovery of melanoma in eight patients from an earlier Phase II clinical trial.
Survival in individuals with advanced melanoma is six months to two years, and few treatments exist. Superficial melanoma lesions can be removed from the skin but if the deadly cancer develops in the intestines or other body tissues the prognosis is poor. Early detection of melanoma that often appears as a mole leads to the best outcomes.
"Very few treatment options exist for patients with advanced melanoma, none of them satisfactory, which is why oncologists are so excited about the results we found in our Phase II study," said Dr. Howard Kaufman, associate dean of Rush Medical College and director of the Rush Cancer Program. Kaufman is leading the Phase III study.
OncoVEX was originally developed to treat herpes. Discovery that the vaccine could treat melanoma occurred by accident when scientists put it in a Petri dish with cancer cells. In addition to killing cancer cells, OncoVEX also boosts immunity.
In the Phase II trial, OncoVEX was given to patients with advanced melanoma that had spread to other parts of the body and had not responded to other treatments including Interleukin 2 - an immune boosting therapy that is in Phase IV clinical trials - and who had not responded to chemotherapy.
The overall response rate for melanoma treatment with the vaccine OncoVEX was twenty six percent, compared to 15 percent with other therapies.
The vaccine can be administered at the doctor’s office with or without guided ultrasound and is given directly into melanoma lesions. Patients in the earlier Phase II clinical trial received the vaccine every two weeks for a total of twelve injections, and eight of 50 patients recovered completely.
"What really surprised, and encouraged, us was that the vaccine worked not just on the cells we injected, but on lesions in other parts of the body that we couldn't reach," Kaufman said. "In other words, the vaccine prompted an immune response that was circulated through the bloodstream to distant sites.”
The melanoma vaccine Phase III clinical trial is currently enrolling 430 patients to study OncoVEX in a larger group of patients. The researchers say OncoVEX “showed the best results to date for any vaccine developed for melanoma, but they need to be confirmed in a larger population."
J. Clin. Oncol. 27: 5763-5771