Replies to post #261196 on NorthWest Biotherapeutics Inc (NWBO)

[AVII77]

I would appreciate you can provide more graphs comparing our Double Blind, Randomized, Placebo Controlled Phase III clinical trial with some juicy fancy, you-pick phase 1 and phase 2 trials (there will be abundant for you to pick, maybe IC or Ex, or even learning curve or mini can help you for some raw data),in this way we may be able to better understand your graphs and essence.

OK

Rapid Early Tumor Progression is Prognostic in Glioblastoma Patients

https://www.ncbi.nlm.nih.gov/pubmed/30973372

They looked at survival (and PFS) in patients with and without REP ( Rapid Early Progression).

This was assessed at an earlier time point than the psPD studies we have discussed. They assessed it after surgery but before ChemoRad.

Patients with MGMT promotor methylation had a better OS compared with patients MGMT promotor unmethylated tumors (P =0.042): 21.7 months (95% CI: 15.6-32) versus 16.5 months (95% CI: 11.8-19.9). Kaplan-Meier for OS based on MGMT promotor methylation status and presence of REP are displayed in Figure 2. Survival based on presence of REP and MGMT was 10.2 months (95% CI: 7.1-17.6) in patients with evidence of REP and MGMT promotor unmethylated tumors; 16.5 months (95% CI: 6.4-23.5) in patients with evidence of REP and MGMT promotor methylated tumors; 19.6 months (95% CI: 15-25.1) in patients without evidence of REP and MGMT promotor unmethylated tumors, and 34.7 (95% CI: 17-57.9) months in patients without evidence of REP and MGMT promotor methylated tumors (P = 0.033).

So, in patients who didn’t have Rapid Early progression before chemorad, for Unmethylated they saw 19.6 months and for Methylated they saw 34.7 months.

The DCVax Blended paper reports: 19.8 months and 34.7 months for patients non-progressing following chemorad.

Not an apples to apples comparison but demonstrates the importance of recognizing patient selection issues.