-- Regarding Stable Disease My original inclination about PFS not being reported is because of the handcuffs designed into the current trial. My understanding of the Phase I trial was that most Patients were Stage 4 cancers that has metastasis across the body. DCVax-Direct was only injected into the main tumor. Thus, even though the primary tumor has shrunk or was impacted, other/new tumors are still growing or have expanded to different organs. I obtained my definition of PFS from here:
specifically from this quote. "But progression may also be due to the appearance of a new lesion originating from the same tumor or to the appearance of new cancer in the same organ or in a different organ."
As this is a late stage cancer and DCVax-Direct was only applied to the main tumor and PFS is measured across the entire body, I think it is entirely fine not to report a PFS. In Phase II when the DCVax-Direct will be injected into multiple tumors, I will be very suspect if no PFS data was shared EVEN if it was not the primary endpoint.
Not sure if the above is correct, but hopefully convey's my comfort with the lack of a PFS statistic.
-- Regarding the Population of Slow Progressors in Phase I I think your points about the population of patients NWBO had to select from @ MDA is very fair. One of the largest cancer hospitals, NWBO definitely had a diverse sample to select patients that could've resulted in a high number of Slow Progressors. Guess this will be a wait and see approach. Allow Phase I data to further mature and see over the next 2 to 5 years how many survivors.
-- Regarding Pancreatic Cancer mOS Discussion I think you meant to say "even". Skipping the word itself, I guess my next question here is that the tumor has metastasis across the body. Thus, even though the general cause of death is cancer, would MDA be able to pinpoint the exact reason? Was it from the tumor that was treated? or was it from the complete failure of an organ that had a secondary tumor that ultimately killed the patient (i.e. Metastasized tumor to Lung blocks air pathway)
That trial handcuff of being able to attack only the main tumor makes me question the cause of death for any patients that has passed away. Depending on where the Stage IV has already metastasized to will determine whether or not enough time was give for the immune system to launch a systematic defense (or some version thereof). Some patients were luckier than others because the cancer had spread to areas that were not as critical.
Of course the theory I presented above assumes DCVax-Direct works and is effective to some degree. All of what I described and your own conclusions about DCVax-Direct's limited capabilities are valid. In the end it will take a well thought out Phase II/III trial to prove both our points.
-- All Other Points that You've Shared Where I Have No Additional Comments Thanks, understood
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