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Posted On: 11/12/2019 9:36:07 AM
Post# of 154883
RE: what is "significant" CTC count reduction ...
I believe "significant" refers to whether CTC numbers drop below the "5" number referenced below. RP previously mentioned this in his talks. The idea being that there is a huge set of data that indicates CTC numbers below "5" (not sure what the reference is) are statistically correlated with longer PFS (progression-free survival) and OS (overall survival).
In other words, a potent secondary endpoint on which the FDA might grant accelerated approval given a large enough data set.
As someone else noted, it remains to be seen whether the ACTUAL data is below this number. But, IMO, this is 100% what they are shooting for.
**note the quoted scientist in the link below.
https://www.cellsearchctc.com/about-us/news/d...n-free-and
I believe "significant" refers to whether CTC numbers drop below the "5" number referenced below. RP previously mentioned this in his talks. The idea being that there is a huge set of data that indicates CTC numbers below "5" (not sure what the reference is) are statistically correlated with longer PFS (progression-free survival) and OS (overall survival).
In other words, a potent secondary endpoint on which the FDA might grant accelerated approval given a large enough data set.
As someone else noted, it remains to be seen whether the ACTUAL data is below this number. But, IMO, this is 100% what they are shooting for.
**note the quoted scientist in the link below.
Quote:
In the subset of triple negative breast cancer (TNBC patients), at both the first and second CTC follow-up visits, those with a CTC count of <5 had significantly longer median PFS (p<0.001 and 0.002) and OS (p=0.003 and <0.001) times compared to those with ≥5 CTC . For all 294 patients, the median PFS and OS were 7.9 months (95% CI = 6.8 to 8.9 months) and 20.9 months (95% CI = 17.3 to >24.8 months), respectively.
https://www.cellsearchctc.com/about-us/news/d...n-free-and
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