NorthWest Biotherapeutics Inc (NWBO)

[sharpie510]

NWBO is also going for approval in recurrent GBM according to the first secondary endpoint. And the placebo crossover patients will be compared to comparable patients OUTSIDE of the trial.

Even for the second secondary, PFS must be CONFIRMED PFS (cPFS) = ADJUDICATED PFS? This is looking really good.

E.5 End points
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.
E.5.2.1 Timepoint(s) of evaluation of this end point
October 2020