By comparison, the overall response rate in the OncoVEX trial was 26 percent. Eight of the 50 patients were free of disease by the end of the trial period, which consisted of vaccination every two weeks, for a total of up to 24 injections or until disease disappeared. Four more patients were rendered disease-free after surgery or further vaccination of new lesions. Overall survival was 58 percent at one year, and 52 percent at two years. The results were reported last December in the Journal of Clinical Oncology.
"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.
"These are the best results to date for any vaccine developed for melanoma, but they need to be confirmed in a larger population."
The Phase III trial will enroll a total of 430 patients at centers across the U.S. As with the earlier trial, the vaccine will be injected directly into tumor nodules every two weeks for up to 24 treatments. Patients will be tracked for two years after the first dose is received.
BioVex, in Woburn, Massachusetts, which makes OncoVEX, is funding the study.
|Contact: Sharon Butler|
Rush University Medical Center