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news.A phase III trial of Antigenics' investigational drug Oncophage in kidney cancer has failed to meet its primary endpoint. The disappointing data caused the company's stock to lose nearly half its value.
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The analysis of the data showed a trend in favor of Oncophage for recurrence-free survival, the study’s primary endpoint, but a trend against Oncophage for overall survival, the trials secondary endpoint; however, neither finding was statistically significant.
The company said that it is currently unclear as to why opposing trends were observed between recurrence-free survival and overall survival.
Antigenics is continuing to conduct a thorough review of the safety and efficacy data, and plans to meet with the FDA at the end of April to discuss the findings from this trial.
“We believe that further work is necessary to properly interpret these results,” said Dr Garo Armen, chairman and CEO of Antigenics. “Upon completion of full analysis of the data, we will further refine our Oncophage strategy, which includes testing Oncophage in combination with other agents, and development of a higher-activity Oncophage.”