Replies to post #521106 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

exwannabe,

Patients were matched as best as possible by an external party. The 6% difference in patient category allocation may include biopsy only but is not clear as that category is listed as other or missing. We also do not know the performance scores of those patients and we also know that this small difference can not explain the difference in long tail survival numbers which this small difference in enrollment clearly does not explain especially when those with more residual disease in the treatment arm had better long tail numbers than originally expected. The bias you suggest disparages the independent composer of these ECAs not NWBO as you would imply. I would suggest that there is more to this story that we are not privy to yet that supports the ECAs as composed as there would be no reason to include biopsy only and a greater percentage of patients with residual disease UNLESS other factors were being considered as part of patient comparator balancing. Dr. Linda Liau, Linda Powers and others would see any attempt to sabotage the trial through external comparator bias. Best wishes.

[biosectinvestor]

That’s not exactly what it says. They don’t exclude patients who can’t have a total resection, they say what you say, they are INTENDING to go for gross or total resection, but there is no indication that they excluded patients where they could get an adequate amount for the vaccine. That is very different. They must have 1) resection; and 2) they must get enough tumor for the vaccine. The modifier is with the intent to go for as much tumor as is possible, it does not say excluding…

“Patients must have sufficient tumor lysate protein that was generated from the surgically obtained tumor material. Patients must also have sufficient DCVax-L product available after manufacturing. These determinations will be made by Cognate BioServices, Inc. (Cognate) and communicated to the clinical site through the Sponsor, or its designee.
…

Primary therapy must consist of surgical resection [obviously, and same as the others] with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent Temodar chemotherapy. Patients having a biopsy only will be excluded. These primary treatments must be completed at least two weeks prior to first immunization.”

Are you saying the other trials did not have that same intention if they required surgery? That would be odd…

Granted, the excluded biopsy only patients. I’d want to know more about the other trials and how many such patients they included. Those earlier trials also may have had more patients that are now defined as no longer GBM. One of the challenges, but I do not expect again for these things to be fatal.
You wrote:

“No. Of course every patient (even in trials) is going to have the maximal resection that can be safely performed.

For many patients though, it is known they can only remove some (or none) of the tumor.

NWBO excluded these patients. OTOH, the ECAs allowed biopsies and partials where there was no intent to remove nearly all the tumor.”

They have to have surgery to get the sample for the vaccine. These patients are not necessarily less sick and the tumors grow back rapidly even with near total resection and no doubt the other trials had those patients as well.

Having a huge contiguous brain tumor is not a good or better prognosis for not having rapid recurrence. To a large degree we know if patients just have surgery, with no treatment they are all likely to die rapidly, likely we’ll before the current standard for treatment.

I’d want to know what percentage of those other trials had biopsy, but I do not think the regulators will find that disqualifying given this is a rare disease and the nature of the disease. They could likely touch on it.

And it sounds like NWBO is getting to the point that a small biopsy for future treatments may be enough with their newer manufacturing processes. So that population may be a future opportunity.

That previous trials did not all necessarily differentiate those patients from those with total resection clearly (even if some may have, which I am sure you’ll find if you can), may also be an interesting and telling detail as well about how that is seen in these trials.