@Outlander2 yousaid“the data is coming. Let it be wonderful.”
I refuse to respond to that thread for obvious reasons!
Well, with regard to future data, why shouldn’t it be wonderful?
For me, here are some of the key takeaways ofthe Oct31 data cut which was 32 patients
- as i said previously, the longer on study the better the result. This is undeniably true.
- most of the patients - but not all - that didn't stay on study beyond 50 days and are now "off treatment" and they are almost ALL Cohort 1 patients, ie the LOWEST dose.
- There were only 4 patients from the higher cohorts who discontinued before making the 50 days:there were 2 x Cohort 2 patients, 1 x cohort 3 and 1 x cohort 4 who moved off treatment under 50 days.
- AND those that didn’t make 50 days are almost exclusively marked as progressive disease (PD) regardless of the cohort.
- So you might conclude that a lower dose and/or less time means less of a result? Howeverthe single Cohort 1 patient that persisted beyond 50 days DID manage to achieve stabledisease (SD).
- Now. those who haven't made over 50 days but remain on study are mostly cohort 3 and 4 - which makes sense because they started the study closer to the data cut-off ie they started on the study more recently.
- Importantly, almost all of the patients that have stayed on study OVER 50 days have achieved stable disease (SD) – including that one Cohort 1 patent! Imagine for them, disease control (not better, not worse) at just the lowest dose.Amazing stuff!
- So again, the longer on study the better the result!!
- Also of note is that there are more patients in the over 50 days group who have chosen to remain on study, versus the under 50 days group – suggesting they are more prepared to stick it out.And, the data looks to be on their side here.
- Our complete response (CR) was from cohort 2 and had been on study for over a year
- The partial response (PR) is from cohort 3 and has been on study for about 100 days (before discontinuing)
- So again, the longer on study the better the result
- Of note, no cohort 1 patient remains on study
- US09-003 of Cohort 4 is SD at approx. 70 days and is already showing a reduction in tumor size.They are our first Cohort 4 patient and have been on study the longest for any Cohort 4 patient and they are also IV!
Graph below:
- Note the Dec 31 (per AACR2024) now shows 5 x Cohort 4 patients(3 of which are IT) so we added one since the Oct data cut.
- All those above the line (increase in tumor size) almost exclusively part of the under 50 day group and predominantly Cohort 1
- in the poster version (below), we see there are more cohorts above the line as the newer cohorts obviously came onto study later and then had their first scans
- those with a decrease in tumor size are almost exclusively cohort 2 & 3 and who have all been on study longer
- US09-003 – the first cohort 4 patient - is showing a tumor reduction and who is also IV
- so imagine what happens for Cohort 4 and 5?!
As a result, weshould hope that the remaining cohort 2 and 3 patients choose to stay on study for theirbest response and, hopefully, they also move from SD to either PR or CR.Very keen to see the progress on the 4 continuing cohort 4 patients who were very early into the study.
Low dose, IV patients and the non-pembro patients are all holding their own here.
GLTAH !!
(20min delay)