NorthWest Biotherapeutics Inc (NWBO)

[Doktornolittle]

?Median OS or PFS a poor measure for DCVax-L Efficacy?

LL in her video showed CR for 25% of patients. That seems huge to me.

I don't want to overstate that because I am still out, wheeling and dealing to get more $ fast before the deal here vanishes. In fact; once again had my foot caught in a giant clam 2000 leagues under the sea, for nearly 5 weeks. The clam tricked me into the situation. Flat out lied. Finally, after 5 weeks, I cut off my foot to escape, and literally 5 minutes later the clam opened it's shell. I hate giant clams.

Now trying to find another foot somewhere before I swim over to NWBO.

The 25% CR for DCVax-L is all mesenchymal according to LL. Flipper showed data indicating 49% of GBM patients are mesenchymal. So half of those are showing complete response. Isn't temozolomide effective in about half of GBM patients? If so, is it as simple as low MGMT expression + mesenchymal + DCVax-L = complete response?

Here is one article stating, "MGMT promoter methylation was found in 43.1% of glioblastoma". If 57% don't express MGMT, then that's about right. 57% of patients responding to temador, but maybe the 6% discrepancy from perfect 51% here to yield 25% CR could be attributed to imperfections in the process. That would be a heck of a lot better than the chess master is claiming. Of course these % numbers are not nailed down quite tight enough in these studies to worry about this small discrepancy anyway.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3180167/

Above is in part to allow corrections to how I am viewing this. But where I am going with this is to a concern about Median PFS being the measure of efficacy here. The same concern would apply if the measure was Median OS.

If you had a therapy with a 49% CR, but the other 51% had no improvment, the median improvement would be 0. That sucks, because a CR of 49% would be the an absolute miracle.

So surely the FDA does not look at just median efficacy... nor the PEI for either approval or HE reimbursement... right? I know that many of you know the answer to this.

Of course that is not the exact situation here, but I got the impression from LL that it could be a little bit like this. Further, many subgroups are defined, and one is likely this combination of proper methylation status and mesenchymal; constituting 28% of GBM patients showing a CR in 90%. Wow!
(Assuming the methylation status accounts for the missing 51% factor)