Replies to post #492201 on NorthWest Biotherapeutics Inc (NWBO)

[GermanCol]

I will also present your previous post in quotes, and then respond.

If a patient was in the control arm, and was considered to have evented, then received DCVax, and following this, the clinicians had decided the patient had actually developed psPD from chemo/radiation, these patients would NOT have been removed from the trial.

Presumably, if there were some late psPD patients (from chemo/rad), because the trial was randomized, there would have very likely been some late psPD patients in the treatment arm… and yet, no treatment arm patients were removed for late psPD due to chemo/rad.

I agree. I'm not saying these patients were removed from the trial. They can still be an important part of the trial since they received DCVax at some point and apparently (according to my calculations) had good results. For example they could have been used for the tumor response endpoint.

These same patients would have instead been part of the 64 that crossed over. Period.

You look very sure about that, but let me disagree. Or at least tell you that you cannot be sure of that. We just will be sure when we get the rest of the information. What I said is these patients would not fit in any of the nGBM or rGBM arms according to the primary and first secondary endpoins definition:

The primary endpoint of this study is overall survival (OS) compared between patients randomized to DCVax-L and control patients from comparable, contemporaneous trials who received standard of care therapy only, in patients with newly diagnosed glioblastoma.

The first secondary endpoint is overall survival (OS) compared between patients randomized to placebo who received DCVax-L treatment following disease recurrence, and control patients from comparable, contemporaneous clinical trials, in patients with recurrent GBM.

And, it is unusual that there were only 81 control PFS events of 99 by about 30 months, leaving 18 (right? Not 17: 99 - 81 = 18?) patients not having reflected a PFS event, and yet there are ZERO patients remaining at risk. If those 17/18 patients had died, their death would have also counted for the primary endpoint (according to the protocol).

No, I'm not talking about those 18. I am talking about the 17 difference between the 81 events in the PFS chart in slide 11 and the 64 that finally were considered in rGBM arm. (81 - 64 =17). Why if there were 81 events in the PFS chart, there were only 64 patients in the rGBM arm? The best explanation that comes into my mind is that those 17 patients were considered a PFS event, but then it was realized they were pseudoprogressors, so not a cPFS event and as such, not part of the 64 patients in the rGBM arm. This 17 difference reinforces why I don't think any pseudoprogressor from the initial control arm would be part of the rGBM arm.

The 18 that you are mentoining (99-81) are simply left censors according to the PFS definition from my point of view.

The protocol did not have any provisions whatsoever for removing late pseudoprogressors from either the control or treatment arm. So although you may think that it is possible these patients were removed, this suggestion is not supported by the protocol. Additionally, it would hardly have been fair to remove any late psPD patients (who usually live longer) from the control arm, and then not correspondingly remove them from the treatment arm. And from the looks of that PFS chart shown on slide 11, there were ALOT of treatment arm pseudoprogression patients.

I agree with you. If you look at the quote from my post you were refering to, that was what I was saying that I find possible that some SOC pseudoprogressors where not excluded from the trial because they pseudoprogressed after randomization.

Maybe I'm not totally clear as English is not my native laguage, but I never said they were excluded from the trial.