Saturday, February 09, 2019 5:45:12 AM
I agree with most of what you said , but not all of it.
Try to follow the reasoning below, you will see, it is pretty simple, just a bit of concentration is needed :
I think you omitted one major point. We know for sure two events dates : Feb 2017 : 133 events and Feb 2018 : 208 events. This tells a lot and allows to calibrate our statistical models as Lightrock is trying to do. We are not doing blind statistics !
So :
133 deaths in feb 2017 that's 661 survivors
208 deaths (+75) in feb 2018 that's 586 survivors, yearly death rate was 11,4% (75/661)
As we know death rates diminish in time (that's a from cancer epidemiology), lets apply 11% death rate to the 586. This means 64 died since last year (11%x586). So today's count should be around 272, it can't be much more.
This allows to compute an end of trial date (we still need 26 deaths to reach 298), let's say 1st October 2019
With all this you have 4 points in time : feb 2017, feb 2018, feb 2019, Oct 2019. You can draw a survival curve which will be pretty accurate.
That's all I did, with precise recruitment numbers, logarthmitic curves, assumptions on MK benefit etc etc....
So what it shows, is that the five year observed survival from the WHOLE (TEST + MK) group should be close from 60%. And this is what we want to know, because in whole Head and Neck cancer survival DB we find SOC survival curves much below. For instance, if you take the US benchmark, through the SEER public db you will find 2008 - 2014 five years 65% relative survival for regional Oral Cavity cancer which implies a 56% observed survival (relative is observed less other causes of death). And the US benchmark is on the best in the world. And that's where I agree with you, germany will show something like 50% observed survival (check litterature), UK 56% in best of cases, and India under 50%. Most of the study took place in countries like india, ukraine, hungary, etc... where SOC 5 year survival is likely below 50% for stage III-IVa H&NSCCC
Blinded study ? True, but 60% five year survival in TEST + CONTROL, that means thas SOMETHING is likely to be happening in the TEST arm improving significantly the survival of the whole group of 794 patients.
Funds do have tools to follow this, much powerful than we have. Blackrock is not Lightrock (no pun intended) or Fosco. They probably know all we know and know they have time to invest and to minimize risk they can gradually invest until october. I believe will see more money pouring in as key threshold months are left behind.
Is it more clear Alexander ?
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