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Yes.
That being said, positive evidence of effectiveness is positive evidence of effectiveness.
I'm not worried about it, but it is slightly spin-like wording compared to the trial design.
The results are in, now it is an FDA application, i.e., the past is the past. Whether or not it goes through is a lot more to do with the FDA's modern view of this, PERHAPS, less to do with what the trial design started off with.
Science is science though, and if the "test" needed to hit a high bar and missed, then there IS a question did the science work or not.
Seems to me it worked well enough, but that question is ahead of us and not behind us.
This part seems a little bit spin, in that the 10% overall survival benefit goal was to be measured as of year 3.
A small difference in year 3 mathematically will grow larger as time goes on.
So it WAS to be resounding "proof" in year 3 with a signal that big.
Now it is a question of "ok, good enough?" The effect IS "durable", continues. That counts for something.
Fair is fair, this is slightly misleading, and I am not so much complaining as being technical with this as worded. To be precise, such a statement would be about the numbers AT year 3.
From the statement at clinicaltrials.gov
Thanks, that's pretty big
You'd hope that chemo exists for some kind of valid reason
Whatever it is, let's put that in place of where I said cisplatin :)
https://clinicaltrials.gov/ct2/show/NCT01265849?term=multikine&draw=2&rank=3
am I getting old or what
thx
This one had the tidbit
https://www.onclive.com/view/leukocyte-interleukin-plus-soc-without-chemo-provides-5-year-os-benefit-of-14-1-in-head-and-neck-cancer
My bad, that was the 5 year actual, apparently
That's almost exactly the differential what we wanted to see at 3 year
Are we reading the same thing ?
https://www.irdirect.net/prviewer/release_only/id/4763752
It is because there is positive effectiveness in test and apparently aux arms with and without chemo, that's why.
... and the differential is greater without chemo
My understanding is we can't use the 48.6 because that's SEER data, and we're talking about what actually happened between the test and control arms, etc.,
Maybe it can come out in a scientific paper why the entire population of the study did so well.
Maybe it could say something like "keytruda" was later applied to just about everyone also. That sort of thing. There is no way to know until the papers come out.
The study protocol does not preclude ANY further treatment by ANY means.
Clear ?
Before we got any data whatsoever, the ONLY thing in the world to compare the trail run length to was SEER data.
The actual race is between test and control groups
The part that is most intriguing to me is the part that sounded like the auxiliary group performed outstanding with clear efficacy.
Because the obvious purpose of that arm is to make sure nobody is cheating.
So by the sounds of things, if that's right, then we should be good to go, new doors to open with this tech, and maybe only a $7B/yr concern, but that's not too bad, for now.
Making a dent in this cancer thing is a big deal.
I have little reason to believe with what they've said that we can expect the over all test/control comparison to come up to what they've said about the sub-group.
Just remember though we can make it on secondary measures alone, and there is reason to believe that is going to be good.
The data, so far, also seems to suggest the theory is correct, put immunotherapy before Chemo ( if not eliminate chemo altogether )
Mustard Gas can't be good
Why not just use chlorine
We've been over that before a few times now
If you want to wait for that, that's up to you
Sounded to me like 155,000 need it, per year
Did you miss that too ?
The 5% thing in our case is bolstered by lack of effectiveness of placebo in cancer studies.
Our 5% is not confuse-able with placebo effect
14% at year 5 is 2/3rds of a year added lifespan on average to that population
For immunotherapies that's not 1-3 months, that's substantial - especially into and beyond year 5
... people are alive today that probably wouldn't be otherwise ...
Why are you focused on that when there is a viable sub-group ?
If your light-bulb works when you plug it in, then you go where there is an electric outlet
I don't really know what you can say to the FDA and then publish in a journal later or vice versa
I'd assume that you would publish first and then prepare a filing for the FDA. - but having never dealt with this before I don't know. You kinda wanna have your science peer-reviewed before pressing ahead, otherwise.
Ok, answers:
1. No idea about terminology, that's noise to me
2. Science has to happen the science way, test and control groups and those are the only gospel. Did this light-bulb work better than that one under test conditions for both. I don't care if this one is more popular at home depot or on amazon.com (seer data)
- in order to compare to SEER data, the trial size would have to be of the same order (or within an order) of magnitude as the SEER data - an actual example of that scale is a current example, hey let's try covid vaccines on the entire population of Earth all at once.
( I think the SEER data, going from vague memory, is something like 200,000 samples in our case )
What's the question exactly ?
Generally I'd say we can go back in the history of this board and read about "lightrock resurrection" - so to speak, and thus we spake
Nothing really shocks me anymore but seems we're looking at that exact issue, the SOC did much better than SEER suggested.
Won't know for sure until we get something more "raw data".
Also I think it is thumb sucking to stick to some global expectation when there are clear results of efficacy for at least a sub-group.
Don't follow the thumb-suckers, follow the science
Imagine watching Edison trying to invent the light-bulb one at a time. We'd have gone through this entire process 1,500 times.
By contrast, we tried 923 light-bulbs at the same time and some of them worked, not just one.
It was positive in that group as well, just not as much
Seems they will have to learn more about that
Meanwhile "give it to everybody" sounds good
Good observation
This one makes it sound like the aux arm is saving our bacon
https://www.onclive.com/view/leukocyte-interleukin-plus-soc-without-chemo-provides-5-year-os-benefit-of-14-1-in-head-and-neck-cancer
We haven't heard enough details yet to be "sure"
Like I was saying, now the aux arm weighs, now the secondary measures weigh
Technically, we're in the same boat before the "news" came out
It obviously worked out that way as simply a matter of "SOC"
The SOC said who got what why for those
It is the analysis that makes the observations where what worked best, after the fact
Makes sense that PII was either too small or we didn't look at people in the the process of chemo.
Ok, maybe I read it wrong
The PR seemed to indicate that 5 of the entire population were not evaluable
In turn that suggests that everyone in the study beat the pants off of SEER regardless of which arm they were in
Seems like...
There was efficacy without chemo
There was efficacy with chemo
There is pudding - the needle moved in both subgroups
Pending:
What did the auxiliary arm say ? ( this alone can break it )
What did the secondary measures say ? ( this alone can make it )
Target market remains at about 155,000 cases/yr ?
Don't know the buyer, but maybe they were a short that gave up ?
I am reporting from memory what I remember seeing at the time.
His life-table was 1/0 based, and if I remember right on monthly enrollment, kind of a win/loss sort of thing.
It was not stochastic per enrollee
I don't know how to explain it without going in to too much detail.
To try to make a short story it seemed like his spreadsheet was overly simple, but I didn't complain because he seems to work with this kind of data for a living.
There is no doubt people lived longer than the average expectation.
So much so that seemingly (at least some, AT LEAST) of the SOC must have lived longer than average also.
...
There is a lot of science to study and publish about whatever went on.
Such as, does having a reputable radio-therapy calibration (MD Anderson? right?) make a difference in outcomes.
What other (not prohibited at all) treatments went on.
...
There's no way with the information I have to separate the wheat from the chaff any better. Something about this study population was very positive.
imnsho - enough to suggest that "do whatever we did and everybody is likely to live longer", regardless of what exactly it was that made the difference.
We can suspect, of course, it was in large part due to Multikine.
I believe the man has a Ph.D and works in this field
I can only complain so much
He and I were talking quite a while ago, it was during this time that he changed opinion.
I was discussing the anomaly "lightrock resurrection" with Sun.
I don't know why but that messed him up. He did not give me the rigorous reason(s) why.
My opinion however has not changed.
It appeared to me that the way he was doing kaplan-meier projection was not stochastic in time. It seemed more like a monthly scoring that did not allow for difference in individual lifespan (enough).
THX all
What did I miss ?
Didn't see any news
Whale bail ?
THX, yeah, all is well, just patiently waiting for the report, nothing much really to weigh-in on, been here the whole time :)
I suppose it could all get really exciting if we get mediocre survival but excellent secondary or something like that.
The secondary measures topic could be interesting, quality of life is a thing of its own right.
If the secondary is great but primary not so great I'd wait for a bunch of bail outs and then go back in because it will likely still go to market.
Not wrong, ... yet
It was clear reading the median expectation we should be looking at July when that conversation went through
Dam it
https://www.greencarcongress.com/2021/05/20210519-bloom.html
What's it, May ? Ours should be getting ready to do that soon
Yeah, the world continues to sleep on this ... giant-in-the-making
Couple years ago, still as good as ever
There were a few papers that came out regarding changing the status of cancer cells to a state where they are more susceptible to radiation, various treatments seemed to do that ( not just MK ) but MK was one that had potential to do that.
So, not only treating the immune system, but also (possibly) enhancing the effect of Radio-therapy.
There is no claim to that effect, this is inferred as a possibility due to certain similarities, some of the common cytokines I believe, seemed to do that in other studies of other drugs.
This is kind of a side-note, something to look for when lots of data is published.