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Tuesday, September 01, 2020 4:25:22 AM
Ah, at last some intelligent posters in this board, much better than yahoo's !
Guy I fully agree with your statements.
Recently on the stock, I made some DD and here are my conclusions so far, not sure I am 100% right but I am sharing with you
Just to speak about correct data :
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Please keep in mind the 2018 data : Median OS for the 100 best responders was of 58.4 months with 95% confidence interval (from KM) : 45.9 – 94.5 months
The 40.4 months figure comes from 2017 data. In 2018 more patients recruited in the latest years made it through more years in survival than the previous median, hence 2018 median is higher than 2017.
Therefore 50 patients (half of 100) made it likely between the various points in time in the KM derived confidence interval.
.... Overall survival is at least of 15% (50/331) between month 45.6 (year 3.8) and month 94.5 (year 7.8), average months 58,4 (4.86 years)
We can therefore state with 95% confidence than 15% OS stands between year 3.8 and year 7.8, most likely around year 5.
That was 2018 figure. There are probably better data from 2019 and 2020 as more and more patients (those who were recruited in the later years) ,as Guy stated, are not censored anymore in the KM analysis and survived above the previous median (more than 5 years). This will have as an effect to right offset the confidence interval :
For instance 15% on the overall trial population might conservatively have survived between year 4 and year 8, average year 5.5
Now, please have a look at my extract from SEER Glioblastoma survival database, courtesy SEER
SEER SURVIVAL FOR GBM 2000-2017
For instance 2012 data has shown 10.9% survival at month 36, 7.9% at month 48 and 5.7% at month 60 for the standard population
We can therefore state that this population is surviving longer, including in the low range of the confidence interval.
Conclusion :
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Will overall better survival than expected be enough for approval ?
We do not know for sure because of the SAP changes uncertainties and the crossover design which might make difficult to compare test VS control.
However it is looking obvious that this population is surviving longer and that might be the effect of the drug.
GL all
Fosco
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