The study, which is not intended for registration, showed that in all stage IV patients, median survival improved by more than 50% in the Oncophage-treated arm compared with those in the physician’s choice treatment arm which included the current array of therapies such as chemotherapeutics, biological agents and/or surgery.
Median survival in the Oncophage-treated arm was 20.9 months, versus 12.8 months in the physician’s choice arm.
This is the first phase III randomized trial of a cancer vaccine to show a potential survival benefit in this category of melanoma patients. However, the difference has not achieved statistical significance at the time of this preliminary analysis. A final analysis is expected during the first quarter 2006.
“This potential benefit with heat shock protein vaccination in stage IV M1a advanced melanoma is encouraging and consistent with the concept that immunological therapy is most appropriate for patients with M1a disease,” said Dr John Kirkwood, director of the Melanoma Center at The University of Pittsburgh Cancer Institute.
“These patients are the appropriate target for the most advanced molecular and vaccine interventions. It is in these patients that application of immunological therapies such as the heat shock protein vaccine Oncophage could likely achieve its greatest therapeutic impact,” added Dr Kirkwood.