interim data from can-003 clinical trial, page-7

hi investor450,

I agree that people need to discuss the actual data!

Now, my background isn't with company knowledge, it stems from being involved in research myself. before you get excited, it isn't cancer research, my field is in exercise and type 2 diabetes. BUT, the point is, i understand study design and all that stuff that goes with it.

So, my point about the 7 NRCVAV people, is that their PFS is shown separately becuase they weren't randomized. PFS means how the median (ie. middle) score it took for people to progress, either through CA125, CT or death. So being in the trial first doesn't make your PFS higher, if that endpoint is in-fact reached. It just means that those that haven't progressed will show the highest days until progression score.

Like we both agree on, the problem is that the OSC group have not yet generated this statistic. BUT, the second remission groups results look promising. unfortunately, while im very familiar with research statistics, i am not familiar with those involved in cancer research, nor do i have any clue with regards to drug approval, other than if the CANVAS trial shows statistical significance, there will likely be a pay-day.

Now, if the second-remission group shows a significant difference, and i agree, the numbers may be too low for this to occur, i'm not sure if prima could push for early registration in second remission patients. I really don't know what the rules are for that. The key thing is, the median PFS won't change. AS i posted in previously, the second remission group will at least have a PFS of 400 days, this can only get higher. The OSC have a median PFS of 145, and this will stay the same. This gives us a hazard ratio (effect size used in cancer) of 0.35. That is amazing, provenge had an hazard ratio of 0.78 (thanks to nuts i think who alerted me to that. Sorry if i have credited the wrong person).

Now, as far as my understanding goes, and if i am wrong, i hope someone can point it out. Looking at everyone (1st and 2nd remission), except for the 7 NRCVAC people, we are in this position.

29 treated with CVAC, only 13 progressed. We actually need 2 more progressions until a PFS statistic can be generated, so i am not sure why they have provided one to us
(PFS=365 days). If you look at the figure in the poster, this is actually the first dark green bar from right to left.

22 OSC, 13 progressed. PFS (321 days)

So, the hazard ratio is somewhere around 0.88, which isn't great.

BUT, as i mentioned, median PFS in the CVAC group actually requires 2 more people to progress. If that were to happen today, the minimum PFS we would get is around 400 (the light green bar immediately to the right of the dark green bar above).

That gives us a hazard ratio of 0.80, which is looking much better.

Now, where my lack of knowledge lets me down, is what happens to PFS if those who are at 540 days, and haven't progressed. I'm not sure what happens here.

But overall, it isn't doom and gloom. Like i said, they need to do more stats, the data can be better presented i think. But i'm no expert in the cancer field