Replies to post #233244 on NorthWest Biotherapeutics Inc (NWBO)

[longfellow95]

Great spot, Lykiri.
Lots of content is a rehash of the earlier UCLA video.
But the new bit appears to be at the 44.50 mark where she trails a new trial starting 'in the Summer' (Summer is already here..) which appears to be for recurrent operable GBM.
ICI or placebo as a neo-adjuvant, followed by surgery, followed by dendritic cell vaccination with more ICI or placebo.
(It would have helped if they had set up the camera so that all the screen projection was visible, instead of half the image being a blank back wall.)
So we are probably talking about Pembrolizumab and DCVax in the same P3 rGBM trial. I'm assuming Pembrolizumab rather than Nivo, due to the recent neo-adjuvant study which was Pembrolizumab.

To which my first reaction is huge ambivalence.

And the room elephant:- Is this Merck just donating Keytruda, or something bigger?

[scotty3371]

She is working with medtronic. wow.

[Whitewater55]

What’s surprising about that? I would only assume that she would be supportive of advancing the use of implantable intrathecal pumps for cancer pain.

[trocprofit]

Thanks Lykiri, phenomenal find, IMO. LL gives a lot of insight to where we started and where we are today. I particularly liked when she said:

Pseudoprogression window of up to 60 days! Image read by a trial-blinded radiologist, with no correlation to patient status. In other words scan looked bad, patient looked good, but blinded radiologist says progression...done. Off trial, if you will, and into cross-over. LL says many taken off trial too early. IMO, this is one of the SAP items that needs huge clarification.

I also loved that the SPORE-funded trial starts this summer. Curious why this hasn't been PR'd?

Then this....and LL talks about the two groups, both of whom are far exceeding SOC results.

[FloatServe]

Woahhhh.... 28:00 minutes in-
LL- “the majority of patients actually did get the vaccine at some point, umm so the, so this actually probably turned, is going to turn out to be a very large single arm study that has a variable where some patients got the vaccine early and some patients got the vaccine late”

This is an unbelievable find

[flipper44]

Lykiri, Dr. Liau did clarify her presentation versus slightly less recent versions on one matter in my opinion. She noted that psPD can be confirmed (typically) after 60 days from enlargement as opposed to six months for it to retreat.

I am certain Ex and AVII noticed it.

What does this mean? It means to me what they believe they determined after blinded readjudication is that the apparent wait and see policy, after initial enlargement detected, was probably effective in avoiding second surgery on most psPD.

I think this is likely a very good sign for the trial's ability to detect efficacy. It also means it was likely a more justifiable (apparent) policy.

[alphapuppy]

I finally got around to viewing LL UW video.

Very interesting.

The most important slide, in my opinion, is towards the end when she identifies the new study that is going to open at UCLA this summer

She identifies in that new study it is DCVAX plus or minus a PARP inhibitor. So, DCVAX POST OP is the new standard of care control arm for this study and the experimental arm is adding the inhibitor. Just saying, a scientist would not Ethically, be allowed to put DCVAX as the control arm Unless it was proven as a standard of care.