Hi Biloxi, I believe as you posted , when our
Post# of 157921
(Total Views: 307)
Posted On: 10/15/2025 12:20:57 PM
Re: biloxiblues #157914
Hi Biloxi,
I believe as you posted , when our patients will start 700 mg , 30-90 days later we should see elevation of PD-L1 , hopefully in many.
This is an open trial which mean company will have all this information , and maybe even share it with us.
Personally I am very worry what will happen to these patients with elevated PD-L1 , if protocol will not be amended..
We know those from the beginning are a very sick patients , ( much sicker that in PH 1b/2 trial for treatment naive mTNBC) patients having relapsed refractory form of the disease , they have already received multiply line of toxic drugs , their immune system is already very compromised , and now we hoping their PD-L1 will be high , knowing PD-L1 will be blocking their immune system even more ,
and we not planning to add ICIs for one year.
In mTNBC about 76% of patients died during the first year,
Here should be more ,
So after the trial we may read that when LL is added to the treatment in mCRC , mortality is higher then only with SOC.
That could be our big problem , and I still hope Dr Jay will ask FDA to amend this protocol...
I am praying for this daily..
I believe as you posted , when our patients will start 700 mg , 30-90 days later we should see elevation of PD-L1 , hopefully in many.
This is an open trial which mean company will have all this information , and maybe even share it with us.
Personally I am very worry what will happen to these patients with elevated PD-L1 , if protocol will not be amended..
We know those from the beginning are a very sick patients , ( much sicker that in PH 1b/2 trial for treatment naive mTNBC) patients having relapsed refractory form of the disease , they have already received multiply line of toxic drugs , their immune system is already very compromised , and now we hoping their PD-L1 will be high , knowing PD-L1 will be blocking their immune system even more ,
and we not planning to add ICIs for one year.
In mTNBC about 76% of patients died during the first year,
Here should be more ,
So after the trial we may read that when LL is added to the treatment in mCRC , mortality is higher then only with SOC.
That could be our big problem , and I still hope Dr Jay will ask FDA to amend this protocol...
I am praying for this daily..
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