NorthWest Biotherapeutics Inc (NWBO)

[antihama]

If "A picture is worth 1000 words" what picture will these words generate?

E.5.1 Primary end point(s)
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.
E.5.1.1 Timepoint(s) of evaluation of this end point
October 2020
E.5.2 Secondary end point(s)
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.

The second secondary endpoint, confirmed progression-free survival (cPFS), is confirmed disease progression (cPD) compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.

The third secondary endpoint, PFS, is progression-free survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.

The fourth secondary objective, OS, is overall survival compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221.

The fifth secondary objective is tumor response compared between subjects randomized to DCVax®-L and those randomized to Placebo within Study 020221

What beauty lies here! Every time I read these endpoints, I see the beauty that flows from them! It's scientific art.

The primary and second secondary endpoint should have been the original trial endpoints but we were still learning about the effects of immunotherapy back then. And I know longs love the third (original PFS) and forth secondary endpoint (original OS) because many believe they could still have been SS. For the first secondary endpoint (OS in crossover patients vs recurrent SOC), I do think it's somewhat ambitious since they are not making lysate from resected tumor but it's probably a low bar they have to hurdle (and on the plus side, tumors revert to a more advantageous form for DCVax-L). And the last secondary endpoint is tumor response, and why not, since so many cancer trials are using TR to obtain accelerated approval. That ship has sailed for this trial but could be a hurdle for future trials that they will need to jump over.

Anyhows, thanks for your input and for everybody else on this board for their contributions. And oh yeah, if I could add a pic to iHub I would but not going to attempt it. Right now for me it's a recent pic of Fall foliage at peak on a mountainside overlooking a roaring mountain stream. Hey, that's me; you guys pick your own be it a Rembrandt or whatever. Luckily, I only have ~180 words (in the endpoints description above) to present a picture of.