NorthWest Biotherapeutics Inc (NWBO)

[ATLnsider]

Hopeforthefuture3, there you go again , suggesting that DCVax-L only helps about 25% to 35% of GBM patients.

However, I believe and agree with Dr. Liau and Dr. Ashkan. DCVax-L is helping all GBM patients across the board, but it does help some patients more than it help other patients.

Some people are saying that DCVax-L will only be approved for a subset of newly diagnosed Glioblastoma (ndGBM) patients. They suggest that DCVax-L will only be approved for the 25% to 35% of the DCVax-L treated patients who are included in the long-tail survivors who had Overall Survival (OS) of 5+ years (60+ months).

The OS for the current standard of care (SOC) to treat ndGBM is currently only 14 to 16 months. They say that DCVax-L will not be approved to treat those subsets of trial patients who had OS increases to 18, 24, 30, 36, 42, 48, and 54 months, compared to the current OS for SOC to treat ndGBM, which is currently only 14 to 16 months.

But, these people fail to realize that the current SOC (the Stupp Protocol) to treat ndGBM, became SOC in 2005, even though it only added about 2 months of OS. Also, the Stupp protocol does not benefit all subsets of ndGBM the same. It benefitted ndGBM differently based on their age, methylation status, gene subtype, etc. But the Stupp protocol was approved by the FDA and regulatory authorities around the world, and it quickly was adopted as SOC to treat ndGBM.

I believe that DCVax-L will be approved for all ndGBM and rGBM patients worldwide, and it will quickly become the new SOC to treat all GBM patients worldwide, regardless of age, gene subtype, methylation status, etc.

Dr. Richard Pazdur says the following around the 32:00 minute mark, regarding the reasons why the FDA started Project Orbis:

This has some important aspects in oncology, we really want to have a global standard of care, and when you have a truly important “Breakthrough therapy drug, it is important that it has relatively widespread worldwide distribution and approval as soon as possible because that becomes the new standard of care, and subsequently the new control arm for subsequent trials

https://collaboration.fda.gov/pbq6126oijaa/

Also, note what Dr. Liau says around the 36:00 minute mark in this video:

The whole group is doing better, the treatment and the control group. They seem to be doing better than the historical analysis for this is the issue with why we think the whole group was doing better, there is a crossover arm, so if the patient got progression or was deemed to progression on the MRI scan, they were allowed to crossover

Here is what Dr. Ashkan Keyoumars said on this video around the 5:30 minute mark, which was released after the 2018 blinded and blended DCVax-L trial data was released:

we also have to work with regulatory bodies, and we should probably ought to do that now and even waiting, because we want this available to all the patients. Again, what was very nice about this study is, yes those patients who are in better prognostic groups are going to benefit more, but there is a benefit to all patients, we want this available to absolutely everybody