ANTIGENICS ANNOUNCES DATA FROM METASTATIC MELANOMA TRIAL

Antigenics has announced findings from its preliminary analysis of a randomized Phase III study of Oncophage (vitespen; formerly HSPPC-96) in patients with metastatic melanoma. The study, which is not intended for registration, showed that in all randomized (intent-to-treat) Stage IV M1a patients, median survival improved by more than 50 percent in the Oncophage-treated arm compared with those in the physician's choice treatment arm (20.9 months versus 12.8 months), which included the current array of therapies such as chemotherapeutics, biological agents and/or surgery. This is the first Phase III randomized trial of a cancer vaccine to show a potential survival benefit in this category of melanoma patients.

The international, multicenter, open-label trial randomized 322 patients with Stage IV melanoma to one of two treatment arms: Oncophage or physician's choice in a 2:1 ratio favoring Oncophage, and stratified based on the AJCC (American Joint Committee on Cancer) metastatic stage. Physician's choice included interleukin 2 (IL-2) and/or dacarbazine-/temozolomide-based therapy and/or complete tumor resection, and could also include any other licensed treatments for cancer. The primary endpoint of the trial is overall survival.