Monday, April 25, 2022 10:32:31 AM
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:
https://collaboration.fda.gov/pbq6126oijaa/
Also, note what Dr. Liau says around the 36:00 minute mark in this video:
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:
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