Based on what we saw in the Zaltrap and Dasatinib trials, its seem reasonable to expect median OS in the control arm to come in at around 22 months. Based on this, I have an estimated median OS of 25 months in the custirsen arm. If I'm right, this seems like it may be too close to declare victory, as the closest successful trial I've come across is the provenge P3 (25.8 months vs 21.7 months).
Any insight from those more statistically inclined?
Hi Summer, I was wondering how you arrived at 500 as event trigger. Also, I was wondering if you knew any historical difference between patient prognosis between USA and ex-USA sites. Are patient less likely to seek out clincial trials (vs USA)? Are the generally sicker? Are they less likely to seek out alternative treatments? Ultimately, are differences in OS between USA and ex-USA patients. Again, I alway appreciate your intelligent insights.
Summer, this is probably an unfair question but when has that ever stopped me. Is it possible to calculate what the difference would have had to be to succeed at the interim? I know they haven't disclosed what the required p-value was but maybe you can pick one that you think was likely. Obviously I'm hoping that the difference would have had to be a lot more than 3m which would give us some breathing room with respect to the final.