Replies to post #371992 on NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

exwannabe,

Correct, all reported from randomization. None from surgery. Randomization in Weller et al. 2017 and Stupp et al. 2017 ( and i assume Gilbert 2013 and Wen 2019) took place 3 – 4 months post surgery. One exception, Gilbert 2014 randomized study subjects at an earlier timepoint then the other studies, and any analysis that would use this study as an external control comparator will be conducted both including and excluding this study.

DEC.11, 2019
Dr. Bosch’s Presentation at GBM Drug Development Summit in Boston: DCVax®-L Phase III Trial, “Where Are We, And How Did We Get Here?”

Background Survival Data

Historical Data (Temodar + Radiation)

• Stupp et al. 2005: median* overall survival (mOS) = 14.6 months
• Hegi et al. 2005: mOS in MGMT-methylated** patients = 17.0 months

Recent Clinical Trials (Temodar + Radiation groups)
These trials have similar inclusion criteria to the DCVax-L trial

• Weller et al. 2017: mOS = 17.4 months from randomization***
• Stupp et al. 2017: mOS = 16.0 months from randomization***
• Methylated MGMT: mOS = 21.2 months (from randomization***)
• Unmethylated MGMT: mOS = 14.7 months (from randomization***)

*median means half lived longer, and half lived shorter
** patients with a methylated MGMT gene promoter derive greater benefit from temozolomide chemotherapy
***randomization in these trials took place 3 – 4 months post surgery

https://nwbio.com/wp-content/uploads/Boston-Presentation-v0.2.pdf

ASCO 2018