Antigenics' in-depth analysis of Oncophage shows improvement in recurrence-free survival

By Elaine Rigoli

Tampa, Fla., June 7 - Antigenics, Inc. said an in-depth analysis of its phase 3 study of Oncophage (vitespen) vaccine in kidney cancer found that there was a clinically significant improvement in recurrence-free survival (RFS) associated with Oncophage in a well-defined subgroup of better-prognosis in the full analysis set (FAS), which represents the true adjuvant patient population intended for the trial.

It is in this large group of 361 patients - or 60% of the total FAS population - that the greatest apparent response to Oncophage versus the observation arm was observed, according to a news release.

In addition, the hazard ratio for this group was 0.567, indicating that patients receiving Oncophage had a 43% decreased risk of recurrence compared with patients in the observation arm, the release said.

Overall survival, the secondary endpoint of the study, was also assessed in the 604 patients included in the FAS population. Preliminary analysis indicates a trend against Oncophage; however, the survival data are immature, the release said.

The company said it believes the data are likely influenced by missing information caused by patients who were lost to follow-up or withdrew consent.

At the time of data cut-off in January 2006, 31 patients (10.3%) had died in the Oncophage arm versus 22 patients (7.2%) in the observation arm.

As of May, seven additional deaths have been reported, with two in the Oncophage arm and five in the observation arm.

Antigenics is a biotechnology company that has headquarters in New York.

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