OK so coming back to the exclusion criteria. Anyone that thinks the mOS for the placebo arm is going to come in at 13-17month like historical SOC is going to get a nasty surprise.
Remember that this trial has the rapid progressors removed, not the pseudoprogressors. We know the effect on overall survival of these patients (when DCVax-L treated )since it’s the 51 patients in the info arm….their mOS came in at 18.3 months with only 1 patient a confirmed pseudoprogressor. So flip I do not buy this argument that the trial is going to do great because they removed the long lived pseudoprogressors.
The other important exclusion criteria is the removal of the biopsy only patients which will make “everybody live longer”. Did anyone stop to think why the placebo arm in the rindopepimut trial came in with a mOS of 21 months? I put it down to 2 factors 1) The exclusion of biopsy only patients (ooops like DCVAx-L) and 2) The selection for EGFRvIII expressing patients that are known to live longer.
If the placebo arm comes in at 21 months mOS for DCVAx-L then it is screwed. However I don’t think it will since there’s no selection for EGFRvIII expression in the DCVax-L trial. Montano et al., Neoplasia, 2011 is actually pretty useful for getting an idea of the life extension due to EGFRvIII expression since it´s kind of internally controlled. Looks like EGFRvIII selection gives about a 4 month survival advantage compared to the general population. Therefore i’d guess that the non-biopsy placebo patient’s in the DCVax-L trial will come in at about 17 months at the high side of SOC which should be OK. It might come in even slightly higher considering the fact the shorter lived rapid progressors have been removed.
From my own analysis with the new data since 5th June this trial is going to have a positive result (at least for OS and assuming no placebo effect) but it’s going to be a lot closer than people think…just to put in my 2 penny worth
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