NP has been saying we need at least a few patients
Post# of 148258
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Posted On: 07/19/2021 12:18:03 PM
Re: HouseofCards #96679
NP has been saying we need at least a few patients/subjects who are responders for some period of time, and to show some significant improvement over standard of care. It now seems like we have confirmation that the 72% (or 70%?) of combined mTNBC subjects that have reduced CAMLs have improved overall survival (no word on tumor shrinkage or not) at 12 months.
It would be good to have some solid numbers instead of having to piece it together onself, but here goes.
As of SK presentation (last month?) we had just gotten approval to go to Cohort 3 at 700 mg. The mTNBC CD07 trial seemed to be a "standard" "3+3" dose escalation study with up to 18 subjects. I believe there were 3 at 350 mg, 3 at 525, and they just started dosing at 700 mg. So, that makes maybe 6-10 subjects dosed in CD07, or perhaps it could be N=6 in each cohort and we are now up to 12-15? If correct, then the majority of the 30 subjects reported on were in the compassionate use study, 15-20 of them or so.
How do we get to 72%?
22/30=73.3%; 21/29=72.4%; 20/28=71.4%; 19/27=70.4%; 19/26=73.0%;
18/25=72% seems most likely; so 5 of the 30 apparently haven't reached the 12 month mark yet.
I believe they were able to calculate *median* PFS, which was up from 2 months to 8 months!
Not sure of how they got 450% increase in OS.
So, the numbers and water are muddy, as is typical with CYDY PR. They combined CD07 with compassionate use data, two different populations. They didn't give actual N for each trial, or list the mPFS (seems to be 8 months in the 18 with lowered CAMLs).
Can anyone piece together how they calculated 450% in OS (from median of 6 months to 21 months? or are they using some other calculation since less than half the 18 have not died yet, thankfully, and no median is known? possibly did they use % alive at 12 months = "OS12"?).
mTNBC survival varies with site of mets:
https://www.verywellhealth.com/triple-negativ...is-4778440
So, we need to know the site of mets I think.
More numbers would be good.
It would be good to have some solid numbers instead of having to piece it together onself, but here goes.
Quote:
results from its Phase 1b/2 trials and compassionate use with a total of 30 metastatic triple-negative breast cancer (mTNBC) patients
As of SK presentation (last month?) we had just gotten approval to go to Cohort 3 at 700 mg. The mTNBC CD07 trial seemed to be a "standard" "3+3" dose escalation study with up to 18 subjects. I believe there were 3 at 350 mg, 3 at 525, and they just started dosing at 700 mg. So, that makes maybe 6-10 subjects dosed in CD07, or perhaps it could be N=6 in each cohort and we are now up to 12-15? If correct, then the majority of the 30 subjects reported on were in the compassionate use study, 15-20 of them or so.
Quote:
Key findings from the interim 12-month analysis include the following:
72% of patients had a decrease in CAMLs (cancer-associated macrophage-like cells) ~30 days after induction of leronlimab
The decrease in CAMLs was associated with:
A ~300% increase in mean progression-free survival (mPFS)
A significant ~450% increase in overall survival (OS) at 12 months
How do we get to 72%?
22/30=73.3%; 21/29=72.4%; 20/28=71.4%; 19/27=70.4%; 19/26=73.0%;
18/25=72% seems most likely; so 5 of the 30 apparently haven't reached the 12 month mark yet.
I believe they were able to calculate *median* PFS, which was up from 2 months to 8 months!
Not sure of how they got 450% increase in OS.
So, the numbers and water are muddy, as is typical with CYDY PR. They combined CD07 with compassionate use data, two different populations. They didn't give actual N for each trial, or list the mPFS (seems to be 8 months in the 18 with lowered CAMLs).
Can anyone piece together how they calculated 450% in OS (from median of 6 months to 21 months? or are they using some other calculation since less than half the 18 have not died yet, thankfully, and no median is known? possibly did they use % alive at 12 months = "OS12"?).
mTNBC survival varies with site of mets:
https://www.verywellhealth.com/triple-negativ...is-4778440
Quote:
The American Cancer Society breaks five-year survival rates down into three categories:9
Local (91%)
Regional (65%)
Distant (11%)
So, we need to know the site of mets I think.
More numbers would be good.
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