12:00 AM
Mar 27, 2006
 |  BioCentury  |  Product Development

Protocol overshadows Oncophage

At first blush, the failure of Antigenics Inc.'s Phase III trial of Oncophage in renal cell carcinoma looks like either the company or its CRO or investigators didn't know what they were doing, either in terms of controlling enrollment or in calculating the number of events required to determine recurrence-free survival, the primary endpoint. But as with so much in clinical development, the reality is more complicated. As a result, it's hard to draw any conclusions about the efficacy of Oncophage from the data.

Oncophage vitespen is created using the patient's own tumor, from which the heat shock protein gp96 and associated peptides - the relevant antigens from the tumor - are isolated to create the immunotherapy. The RCC study was to enroll patients who had no residual disease or metastases following surgery.

The analysis of the primary endpoint was to be triggered by the occurrence of 214 events, defined by recurrence of disease or death. In fact,...

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