The results do not show a statistically significant benefit for the co-primary endpoint of progression-free survival, nor for secondary endpoints of overall response or disease-control. All observed differences in currently available endpoints numerically favor the group that received Genasense®.
Here is what they are going for now:
Overall Survival
Overall survival – the other co-primary endpoint in AGENDA – is too early to evaluate, as prospectively specified. An analysis for futility, which was defined as ‰¥ 50% conditional power to observe a statistically significant benefit of Genasense under the prospectively assumed hazard ratio of 0.69 and alpha level of 0.05, was conducted for the co-primary endpoint of overall survival. AGENDA has passed this futility analysis, and the Independent Data Monitoring Committee for AGENDA has recommended to the Company that the trial continue to completion. Pending availability of sufficient funds, Genta's Board of Directors has indicated that the trial should continue until the analysis for overall survival can be conducted.
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