NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

NWBO is (supposedly) planning to use historical comps to show the P3 trial has been a success. As such, that makes any trial with decent comps a subject of discussion for this message board.

The CHECKMATE-548 trial has a very similar population to the methylated population of the DCVax-L P3. That the 548 placebo arm did just as well as the -L blended meth+ arm is a valid discussion point.

Per the abstract:

RESULTS

As of December 22, 2020, median PFS was 10.6 months (95% CI, 8.9–11.8) with NIVO+RT+TMZ and 10.3 months (95% CI, 9.7–12.5) with PBO+RT+TMZ (HR, 1.06 [95% CI, 0.90–1.25]).

Median OS was 28.9 months (95% CI, 24.4–31.6) with NIVO+RT+TMZ and 32.1 months (95% CI, 29.4–33.8) with PBO+RT+TMZ (HR, 1.10 [95% CI, 0.91–1.33]).

Among patients without baseline corticosteroids, median OS was 31.3 months (95% CI, 28.6–34.8) with NIVO+RT+TMZ and 33.0 months (95% CI, 31.0–35.1) with PBO+RT+TMZ (HR, 1.12 [95% CI, 0.87–1.43]). Grade 3–4 treatment-related adverse events were 52.4% and 33.6% with NIVO+RT+TMZ and PBO+RT+TMZ, respectively.

The trial actually did measure IDH1+ (unlike NWBO'd -L P3) and thatd ata will be in the full results when we see them. But the lack of that means little when we have not idea what the DCVac-L P3 IDH1+ status was (or even if they can reliably determine it this late).