Thursday, June 06, 2019 7:31:33 PM
So you see, I'd argue that all of the indeterminate group were NOT pseudo progression patients (no matter what LL says). And coming from that position, and that I can agree that it's likely 11 were psPD, then the percentages, as I see them, were more like this.
3/11 lived to 7 years - so 27% lived 7 years
5/11 lived to 5 years - so 45% lived to 5 years
mOS of that group of 11 - looks to be about 60 vs. Gunjur (whoever that is) saw 27.4.
Sentiment,
mOS around 60 months for the pseudo-progressors in the treatment goup, that is interesting.
Let's go back to Linda Liau's December 15, 2016 Presentation at Seattle Science.
Remember that is 16 months after the hold on recruitment and less than 3 months before the first interim data of March 8, 2017.
A few words about Linda Liau:
A few days ago she gave a presentation at the Mayo Medical Center in Rochester. ( I saw a picture of her presentation on Twitter)
And this is a quote from a recent introduction:
Her research interests include translational experimental therapeutics of cell-based immunotherapy for brain tumors
and the characterization of biomarkers of response to immune-based therapies.
She is internationally recognized for her achievements in understanding the immunology of malignant brain tumors and pioneering the use of dendritic cell-based vaccines for glioblastoma. Clinically, she has developed novel ways to map brain function during awake brain tumor surgeries, and specializes in surgery for brain tumors in eloquent areas.
https://www.aans.org/en/Annual-Scientific-Meeting/2019/Featured-Speakers
Back to Linda Liau's December 15, 2016 Presentation at Seattle Science.
I believe that Linda Liau was very accurate in her comment that was based on her expertise.
some quotes:
But in reality, when you treat patients, if you give them the option, you tell them if you can live three more months with this therapy, versus, you have a twenty to thirty-five percent chance of living five more years, most patients would actually opt for
that thirty percent chance of living five more years than okay,
I’ll do this and I’ll give you three more months.
And then also I think, as with any treatment, there’s going to be a subset of patients that benefit, and some that do not. Cause obviously with these immunotherapy trials, twenty-five,thirty percent have that long tail.
So in conclusion, brain tumor vaccines are feasible and safe, and can potentially lead to a significant subgroup of long-term, meaning greater than five year survivor, progression-free survivors.
So this is just not being alive, it’s being alive without progression.
And I think, you know, for patients, that is meaningful. Granted, it’s not everybody, like I said, it’s about twenty-five percent,
but if we could identify who those 25% of patients are to get on these trials, that may be meaningful.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=144937000
So in conclusion i think that Linda Liau expects that probaly 30% of the treatment group will live 5 years or more and 25% of the treatment group will live 5 years or more without recurrence.
So, let's apply that to the current trial:
30% of the treatment group of 232 patients = 69 patients.
25% without progression = 58 patients.
I assume 5% pseudo-progressors = 11 patients.
I agree that mOS of the group of pseudo-progression patients is probably around 60 months.
That means that 12 patients will be dead before 60 months and 11 will live 5 years of more.
If this reasoning is correct, we have around 23 pseudo-progression treatment patients in this trial.
Back in August 2015 most of these 23 pseudo-progressors were still alive.
I think it is reasonable that there are a few pseudo-progressors in the placebo group.(chemo-rad.)
Let's assume there are 8 pseudo-progressors in the placebo group.
Because of 2,3:1 randomization you can expect 18 pseudo-progressors in the treatment group.
So, in conclusion we probably have 5 more pseudo-progressors in the treatment group.
Sentiment, do you think that because of these 5 extra pseudo-progressors in the treatment group they put a hold on recruitment? And remember most are still alive at the time of the hold = August 2015 and you can assume that the group was less than 23 patients because at that time only 300 patients were randomized.
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