Wednesday, November 09, 2022 8:35:19 PM
As you may remember, I have been saying that part of the 35 patients not included in any of the nGBM / rGBM arms could have been pseudoprogressors from SOC that received DCVax-L (after initially being mistakenly thought to be real progressors), but were not included in the rGBM arm because they were not really recurrent patients. If they exist, they would be part of the following subgroup of the 35:
Patients in the original placebo arm that had PFS events but were not included in the rGBM arm:
81 PFS events - 64 patients in rGM arm = 17
Now I think that some of the group of 35 could also correspond to patients that without having recurred, started receiving DCVax after it was realized that there was no placebo anymore in the trial and patients were going to be compared to external arms. Which I think was the plan from long time ago, before presenting the SAP. I also think regulators were on board from that time, otherwise why the trial ended with exactly 232 patients in the DCVax nGBM arm, exactly according to the plan, leaving the placebo short by 17 patients. If they exist, they would be part of the following subgroup of the 35:
Patients in the original placebo arm that didn't have PFS event:
99 - 81 = 18
If this is the case, the group of 35 could have a good mOS as numbers suggest. And the reason is not that DCVax doesn't work like some here like to sugest, but the opposite, that it works very well.
As previously expressed, I think final resuls are going to be better supported by this and other facts than what we have seen until now.
* English is not my native language.
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