Sherlock57, I always enjoyed reading your posts
Post# of 158771
I like to answer some of your points, I am sure not in as perfect English ,
But I will try to go by your paragraphs ...
" I like to see the efficacy of LL mono-therapy as well."
--Well you will not see it in this trial design, as for this we will need 3 arms,
1- only LL
2--only chemo.
3 --chemo plus LL
"Pretty darn numbers for MSS mCRC "
--True , but we know that from the MOA , LL should have positive effect on its own , M-i-L was on monotherapy , improved dramatically , and was a live I believe for about 3 years.
But we don't know how we affected her PD-L1 , and maybe she will be without cancer , doing well until now with ICI...
" sure the numbers are small "
--Yes vey small number and without us knowing the PD-L1..
" Mfglola -as far as the rollover protocol may work out -how they define "disease progression "
--There is much more then survival ,
tests , MRI and other scans are showing percent of shrinking or growth of cancer , new lesions or some are gone.. Many , many ways we know if patient is improving..
"If the protocol is changed to give people an ICI as their PD-L1 numbers rise we not going to get much in the way of OOR numbers "
--True , but as we said above , if no new lesions , some gone or getting smaller , we will know.
" But that would be like changing horses in mid-stream"
--No it will not , protocols are amended with new information all the time..
"One final comment on a practical issue ,
Trial is open label so anyone can leave the trial and ask for ICI."
--You know this will not happen.
How many patients will know this details . Not all the doctors will .
My adult son was dying with severe Covid in 2021 , I knew about LL so I asked and Dr NP gave him RTT LL ,
My son survived.
But about 2 M people died only in USA because they didn't know.
Maybe no patients will develop elevated PD-L1 in CRC , but if they do , and we know this will be blocking their immune system from attacking cancer cells ,
If anyone care for the patients , they will try to get this protocol amended.
And to a people who don't think it is important , just know , this is medicine and life , tomorrow any of us could be these patients.
GLTU.