NorthWest Biotherapeutics Inc (NWBO)

[Evaluate]

You wrote: Quote:
The first secondary objective is to compare overall survival (OS) 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.

This endpoint is really similar to the earlier secondary endpoint from the original trial, EXCEPT, that the control arm will be historical arms, and not the control arm for this trial

IMO, this new secondary endpoint/objective is completely different from the earlier secondary endpoint from the original trial, which did not at all look to compare patients who had a tumor recurrence.
Instead, the old secondary endpoint looked to compare OS between patients who started in the treatment cohort versus patients who started in the placebo cohort.
In this new secondary endpoint, all the patients who started out in the treatment cohort of the DCVax-L trial are not taken into account at all ... instead the ONLY patients from the DCVax-L trial being compared are those who start in the placebo cohort, and then have a tumor recurrence. Thus: recurrent GBM.
And most of these patients would have crossed over upon recurrence and then received the “real” DCVax-L vaccine.
And ... from LL comment that all patients (who received DCVax-L ... early or late), we can assume that this group of recurrent GBM patients did relatively well.
This above group is then compared to Control patients from comparable contemporaneous clinical trials whom also had a GBM tumor recur. And we can assume from the poor prognosis from such patients in the past, with no effective treatment choices, that this control group would not live as long as the above group of recurrent GBM patients in the DCVax-L trial.