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Thursday, February 15, 2018 1:42:57 PM
NWBO never said that. Yes, they did state they had reached 248 PFS events - which was the “threshold” for the trial; however they also stated in their February 6, 2017 PR that they would continue to accumulate PFS events as the trial continued. That does not sound like it was ready to be analyzed, as much as some of us would like some analysis.
https://www.nwbio.com/nw-bio-announces-lifting-clinical-hold-dcvax-l-phase-iii-trial-fda-progression-free-survival-events-reached-overall-survival-events-not-yet-reached/
By the way, "threshold" is defined as: the magnitude or intensity that must be exceeded for a certain reaction, phenomenon, result, or condition to occur or be manifested.
The company stated at the ASM (which Adam also cites in his article) that they have analyzed the data every spring. What he is only correct about is that they haven’t disclosed it.
You’ll see later how no investigators involved in the trial state what he states here. And so who are these so-called experts stating this is extraordinary who ARE investigator’s in the trial? There are none. There are just two “outside cancer experts.”
Guess what, Dr. Don O’Rourke is NOT an investigator. The hospital he is affiliated with did enroll patients, however. But Dr. Don O'Rourke is chasing a different treatment modality in GBM - he is the the lead investigator on a… drum roll please… CAR T trial for glioblastoma (ahhhh). In fact, he’s loading the CAR Ts with EGFRv3 (double ahhhh).
Let's see if that doesn’t color every quote for you that he makes thereafter.
Dr. Don and CAR-T:
https://www.pennmedicine.org/news/news-releases/2016/april/pennled-team-presents-results
So no one can think of a trial that’s delayed their results by a year?
AstraZeneca did for it’s PD-L1 MYSTIC study. I don't know how long they delayed it for but I know they delayed it. But Adam probably forgot them.
https://www.fiercebiotech.com/biotech/astrazeneca-delays-pd-l1-data-rejig-late-phase-program
O’Rourke forgot them too.
Cue Adam to the phone, he calls Dr. Walbert (who actually is a PI for the trial), who states no one knows what’s going on. If he’s a co-author, then he knows what’s going on, he just ain’t telling Adam. If he’s not, well then too bad for him. Remember I did suspect Adam was calling these people.
lol, like they are going to tell Adam anything. By the way, the subject of a futility verdict on DCVax has been discussed forever here. If one thinks a futility recommendation was made, I’d consider looking at who would make such a futility recommendation. Then, like with Dr. O’Roarke, I’d look to see what they might stand to gain by making it. Just saying.
Okay, he reported something accurately.
Consider the source people. This is coming from a big CAR T fan here who is NOT a PI for this trial.
I can’t find this quote attributed to Prasad elsewhere, so it would seem he said it directly to Adam. I had thought Adam and Prasad didn’t get along so I’d initially suspected he’d found this quote in another article and used it, because Prasad is pretty well known for endorsing this perspective.
But I will point out that Dr. Prasad also was interviewed back in October 2016, and that he stated that when a trial is based on the rate of death (OS), if it takes longer for people to die, guess what? It’ll take longer to generate the result.
Here's what the outside cancer expert Prasad said (it's actually pretty interesting),
https://www.managedcaremag.com/archives/2016/10/conversation-vinay-prasad-md-first-do-no-harm-you-must-start-good-evidence
So back to Adam’s recent hit piece.
Yawn.
Uh huh. Blah, blah. But wait, Adam thought Rindo was going to do fabulously targeting the same EGFRv3 that Dr. Don is targeting with his CAR T GBM treatment. And we all know how Rindo turned out. And I thought Provenge was still being used, or did I miss something?
No surprise there. Of course Dr. Don thinks that.
But I have to ask, since when did the industry back dendritic cells? I also want to remind you that phRMA did feature this ad in late 2017, so I’m kinda thinking they are thinking they may be moving on to dendritic cells. I'll just feature their ad again here in my post. :)
Finally, Adam gets it.
Unfortunately, it takes awhile, as Dr. Prasad forgot he said earlier, it takes longer when every one is living longer.
Well a lot of us here kinda predicted Celldex would eventually fail, right? Their vaccine killed off the EGFRv3 protein, but so what? The tumor just came right back without it.
Material events that could effect biases in blinded clinical trials are not usually disclosed, of course, unless they are bad. So I’m going out on a limb here, but… it must not have been bad. Or rather, it probably turned out not to be bad. Though there may have been a few involved who were bad seeds maybe even receiving honoraria that really tried to push the concept that it was. I wonder if there were, were they taken out of the loop and no longer had access to the information? Just a WAG.
Yes… although the ASM note did provide us with some new insights. Adam too, but he, as usual, misunderstood them when he reported them.
Hahahahaha. Dr. Portnow is a PI for the P3 trial. Her answer could be true, or it could be what she felt was the appropriate answer to give Adam who was obviously calling the PIs in the trial.
Of course, O’Rourke is not an investigator in the DCVax-L trial so how would he know?
I’ll instead take the opinions of the 65 co-authors on the upcoming article over his. I’m sure this outside cancer expert Dr. Don O'Rourke has absolutely no idea what is going on with the DCVax-L trial.
And that's it in all its not very exciting entirety. :)
https://www.statnews.com/2018/02/15/northwest-bio-clinical-trial/?utm_source=STAT+Newsletters&utm_campaign=42879d981d-Readout&utm_medium=email&utm_term=0_8cab1d7961-42879d981d-150144869
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