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.
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