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Re: pennymonster1 post# 222490

Saturday, 04/13/2019 1:42:34 PM

Saturday, April 13, 2019 1:42:34 PM

Post# of 701716
Haha... yes.

And that won't happen.

First off, all the control patients start off only on standard of care treatment - temozolmide and radiation. The entire trial has also been "culled" for both rapid and pseudo progressing (fast but false progressing) patients. Rapid progression patients progress because unfortunately, their GBM is fast progressing. Meanwhile, pseudo progression patients falsely progress on standard of care because they are having a "reaction" to the combination of chemotherapy and radiation. In a sense, the combination is working and causing a reaction that appears like a progression when it isn't. The same thing is happening with immunotherapy drugs... and most of us believe it is also happening with some patients due to DCVax.

Anyhow... back to why it won't happen.

The treatment patients begin to receive the treatment as soon as they are randomized into the trial. When and if they event (falsely or really), they cross over to... the same thing they were on before. There is a difference though, and that is they begin the treatment course all over again which means they receive the more intense regimen that always starts the course of treatment off. So they are receiving a lot of immunotherapy help, reving up their immune systems, straight out of the gate. Plus, it's possible that treatment patient really never even evented!

Meanwhile, the control patient receives nothing but the SOC. And believe me, that is treatment is exhaustive and is doing nothing to help boost the immune system of that patient. When the patient finally events... and for the most part, give or take a few patients that may have slipped through the screening process, they are truly eventing - meaning their GBM has returned. That's when that patient gets to cross over and begin receiving DCVax-L. So if DCVax works - and the blended data in this trial is surely indicating it does, IMO, the control patients are receiving it 4 to 18 months later than the treatment patients to.

Additionally, the P1/2 trials using DCVax that were done at UCLA showed that the recurrent GBM patients had a mOS of 17 months, give or take. I'd have to look it up and I don't have time right now. But the recurrent GBM patients somewhat represent the crossover control patient in that they didn't begin treatment until after recurrence. But... in the P1/2 trials, their vaccines were made from their recurrent GBM, and not their original GBM. One would think that would work even better, as their current tumor is being treated with a vaccine made from it; whereas in the DCVax trial, the control patient's recurrent GBM is being treated with the vaccine made from the original tumor. I'm not sure, though, if in the end, that might not be better to have been treated with a vaccine from the original. We'll have to see.

So...that is why I don't think the control patients will perform the same as the treatment patients. I'm working on a post, in fact, to give further and much more detailed reasons as to why I think that. :)
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