Sunday, June 05, 2016 8:58:14 PM
You have NW Bio's 2013 old protocol assumptions for PFS and OS for this Phase III trial back when the trial was meant to be 240-patients. Let’s review:
During her October 2015 speech, Linda Liau stated that GTR median OS have risen to 22 - 24 month range. But she also made these two statements about the DCVax-L trial:
How do you reconcile your DMC finding futility with Linda Liau’s statement that EVERYONE is living longer? Do you spot the hole in your DMC “halt for futility” hypothesis yet? Would that not mean that AVII’s theory is accurate; and that the vaccine is very effective but the immunotherapy imaging standards do not match? Seriously, think about this:
The trial, as you know is randomized by 2:1; the Intent to Treat population is patients who qualify for Gross Total Resection (GTR). We also know that the best (pseudos) and the worst (rapids) immunotherapy patients are removed, and patients are randomized according to MGMT promoter status, meaning each arm will get their fair share of chemotherapy responders, as such following the old protocol 240-patient endpoint assumptions:
—1/3 of main arm (placebo cohort) is expected, after randomization, to have median event of 7 mo. PFS; 17 mos. OS.
—2/3 of the main arm (treatment cohort) is expected, after randomization, to have median event of 13.5 mo. PFS; 34 mos. OS.
For Linda Liau’s statements to be truthful, that means that the trial median needs to have a SIGNIFICANTLY high OS in both arms. Her statements suggest that they can not be falling short on their protocol assumptions. They can only be exceeding them. If this trial is removing pseudo progression patients prior to enrollment, and yet OS for a mixed MGMT promoter status is so high, where 80 of 240 patients are expected to >34 months OS, well that is some mighty strong acting placebo. Don’t you agree? If not, then show me one GTR SoC study, where the median OS surpasses 24 months (Linda confirmed this trial is surpassing) and yet the study has no pseudo patients within it. You won’t be able to do it. :)
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