Re: Perifosine in Colorectal cancer Treatment - Timeline
If the Phase III Trial is not complete and blinded I don't know how they can speak about data from that trial.
As for approval, if you look at the extremes, if it's 5 vs. 8 we're talking a 60% improvement, probably no problem at all. On the other extreme, if it's 6 vs. 7 we're talking about roughly a 17% improvement, not impossible to gain approval but probably would require substantially more data.
I can't say how such big differences occur, but perhaps Phase II are less random then they should be, i.e. Doctors selectively put the patients they think will see the greatest benefits from experimental drugs in the group receiving them. Phase III is run more like a lottery, no cherry picking the patients.
The question is Phase III data is coming from, or is it an approximation made only from the partial data to date. I note 215 dosed in each arm, 360 deaths, nothing says how many deaths in each arm. On one extreme, if all 215 in the placebo are died, only 145 of 215 in the Perifosine arm would have died and their median was only a couple month longer, but 70 patients remain alive who will move that median to the right. Of course this is the most positive possible extreme, it's likely there are still some survivors in the Placebo arm, but without having the actual K-M curves I don't think you can accurately interpret the data.
I'm certainly no expert on this trial, nor do I know how many more patients must pass before it's considered to be concluded, but at some point actual K-M curves will be produced and they could show an improvement in the median because of more patients in the Perifosine arm still being alive if that is truly the case.