Replies to post #653807 on NorthWest Biotherapeutics Inc (NWBO)

[TTsr]

Incredibly stated… but I don’t think he’ll understand (on purpose)!

Thx for great summary!

[meirluc]

Absolutely right GermanCol but let's look carefully at lessons to be learned
from No. 2.

2. 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 recurrent GBM.

JAMA only gave us the No. 2 data of the mOS after recurrence which was a
remarkable 5.4 months longer for the 64 patients receiving DCVax-L after relapse
than it was for the matched external controls (13.2 months vs. 7.8 months).
However, JAMA did not compare the mOS of those two groups from the
time from randomization..

In my opinion the absence of this comparison was due to the fact that the
64 patients receiving DCVax-L after relapse had as a group, an mPFS that
was longer than the average whereas the 35 remaining members of the
original 99 placebos had as a group a shorter than normal mPFS and
according to Dr. Liau, their mOS was also relatively short, which would not be
surprising.

Given a longer than average mPFS of the group of 64 patients and the fact that even
after progression this group lived 5.4 months longer than did the matched
external controls after their progression, the total mOS difference from
randomization between those two groups would be far greater than 5.4 months.
However, given the longer than average time to progression of the 64 crossovers,
it may not be proper to compare the mOS of that group to the mOS of the
matched external placebos.

However, a comparison of mOS values between the entire group of 99 original
placebos and the matched external controls is appropriate because as a group.
the mPFS of that group of 99 was most likely around the average with the 35
permanent placebos having a shorter than average mPFS and the 64 crossovers,
a longer than average mPFS

The entire trial of 331 patients had an mOS of about 20.0 months after randomization
(23.1 months past surgery) whereas the 232 treatment patients had an mOS of 19.3
months from randomization. It is likely that if the post randomization mOS of the
remaining 29 permanent placebos (7 of the 35 placebos dropped out) is added to
the 232 treatment patients that group of now 261 patients (232+29=261) would have a
post randomization mOS that would be even somewhat below 19.3 months.

That the mOS of the 64 crossovers when combined with an mOS of about 261 patients
could lift the combined mOS from less than 19.3 months to 20.0 months, suggests that the
combination of a longer than average mPFS and post relapse treatments with DCVax-L, resulted
in a very impressive mOS. I am therefore guessing that the mOS of that group of 64 crossovers
exceeded 24 months.

[dstock07734]

GermanCol,

I assume you are from Germany. I have a question: Was it mandatory before 2023 that clinical trial in EU must be registered on the following website so that the public can have access?

https://www.clinicaltrialsregister.eu/

The reason I am asking is that there is no trace on the collaboration trial between Merck and NWBO.

https://nwbio.com/nw-bio-announces-phase-ii-clinical-trial-program-combining-dcvax-l-and-pembrolizumab-keytruda-for-colorectal-cancer/