Antigenics Inc. (NASDAQ: AGEN) today announced top-line results from its Phase 3 study of Oncophage(R) (vitespen) in kidney cancer patients who are at high risk of recurrence after surgery. The analysis was triggered based on the number of events (defined as recurrence of disease or death of a patient prior to recurrence) reported by study investigators. However, an independent review by the trial’s Clinical Events Committee (CEC) revealed that a substantially smaller number of events had actually occurred. The analysis showed a trend in favor of Oncophage for recurrence-free survival (the study’s primary endpoint), and a trend against Oncophage for overall survival (secondary endpoint); both findings were not statistically significant.
