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BWIS

02/24/17 7:42 AM

#104202 RE: AVII77 #104201

Were these 51 considered the worst of the worst? Was 14 months a great number for that group?

Pablosrv

02/24/17 7:55 AM

#104204 RE: AVII77 #104201

I think it says 15 months.
Could you make a summary of why you think the trial is going to fail?

Barunuuk

02/24/17 10:59 AM

#104240 RE: AVII77 #104201

AVII, This doesn't include all 51 patients

First off, the title is on recurrent GBM (rGBM) which is different than the rapid progressors. Recurrent GBM patients wouldn't even be allowed in the screening for the P3, let alone the informational arm. The 51 information arm patients were all pre-screened and were initially included in the trial, but didn't pass the baseline MRI visit on month 2, so where then excluded, and moved to the informational arm.

Recurrent GBM is when you have already removed the tumor and it progresses, and so this second cohort of rGBM (8 patients), would have had a second surgery to remove the tumor and create the DCVax-L vaccine.

As for the 19, it looks like the 19 are part of the 20 rapid progressors, however, still, the overall 51 patients mOS isn't 14 months, as you state, as that 14 is only the 19 patients, not the overall 51 so it doesn't includes the other 31 patients. Even if the 18 months is taken from diagnosis, then from randomization, it would be ~16 months.

Again, as I mentioned, because of how the median is calculated, the majority of these 51 patients would offset one another, which would leave ~ 7 patients between 16 - 19 months (assuming everything has been adjusted to diagnosis) that would effect the median, which, depending on the data (if there is a lot of patients in the 18-20 OS, might not even effect the median value. If it were the mean or average, yes it would for sure effect the value.

Again, I wouldn't use the DCVax-L informational arm to evaluate that the ICT-107 mOS should be considerably higher than 21 months. For all we know, there could have been substantial amount of pseudoprogressors included that pushed up the median OS to ~21 months. I guess what I am saying is that mathematically we do not know.

However, we do know that the DCVax-L P3 trial measures OS, and PFS from randomization, NOT diagnosis, so it is using the same measuring time stamp to ICT-107 P2.