I'm not focusing my NWBO bear thesis on the use of PFS as the primary endpoint. I answered a question about the pros and cons of PFS vs OS as primary endpoint in front-line GBM studies.
The FDA did not require a crossover in the DCVax-L study. I know, Liau claims otherwise. She's mistaken. No, I'm not calling her a liar. She's just mistaken. FDA has long emphasized OS as the gold standard endpoint in the front-line setting for just about all cancer indications. I can't think of an example right now where OS is not the required endpoint in a front line cancer setting. IF you can provide me with an example, I'm happy to reconsider. PFS and even ORR are approval-worthy endpoints in more advanced lines of therapy, but not front line.
As I've noted previously, CLDX & BMY are using OS as the primary endpoint for their front-line GBM studies. Roche has used OS as the primary endpoint for frontline GBM studies. I know you believe NWBO is super-duper special, but they're not and they don't get a pass to use PFS instead.
There is nothing envelope-pushing about the DCVax-L study. If you want to bet on an envelope pushpin study, then consider the BMY study comparing Opdivo vs TMZ in front-line GBM. You can find the listing for the study on clinical trials.gov. It is expected to begin enrollment soon. This will be the first pivotal study of a checkpoint inhibitor in GBM. If successful, the study will establish a new standard of care using Opdivo instead of TMZ.
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