Sept Letter & PoC Protocol: Based on the positi
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Posted On: 10/07/2025 8:56:42 AM
Sept Letter & PoC Protocol:
Based on the positive data presented at ESMO, we will shortly submit a follow-up Phase II proof of concept (POC) protocol for PD-L1-negative patients with mTNBC. These patients, currently ineligible for ICI therapy, will receive leronlimab plus standard chemotherapy, followed by a regimen of leronlimab with an ICI.
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From a publication:
Among many challenges in PoC clinical trial design and analysis, the application of multiplicity comparison procedures (MCP) is frequently discussed when multiple doses or drugs are included in one PoC study.
https://pmc.ncbi.nlm.nih.gov/articles/PMC8142878/
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We know the historical CRC did not track blood for PD-L1 comparisons.
Our mTNBC ESMO poster says LL/ICI were dosed @ same time & also @ seperate times.
Our next mTNBC trial is now focused on PD-L1-negative patients.
So being a PD-L1-negative patients protocol
--- it would not make sense to extend out the ICI dosing in this trial.
Everything reads like our PoC protocol will now be LL/ICI combo for the metastatic subtype tumors.
Going to be an interesting protocol & reads like it is good odds the LL/ICI combo will be implemented early, like many have debated.
They're covering every base for Leronlimab & for that potentially significant partnership Dr. J referenced about in the past.
Based on the positive data presented at ESMO, we will shortly submit a follow-up Phase II proof of concept (POC) protocol for PD-L1-negative patients with mTNBC. These patients, currently ineligible for ICI therapy, will receive leronlimab plus standard chemotherapy, followed by a regimen of leronlimab with an ICI.
___
From a publication:
Among many challenges in PoC clinical trial design and analysis, the application of multiplicity comparison procedures (MCP) is frequently discussed when multiple doses or drugs are included in one PoC study.
https://pmc.ncbi.nlm.nih.gov/articles/PMC8142878/
___
We know the historical CRC did not track blood for PD-L1 comparisons.
Our mTNBC ESMO poster says LL/ICI were dosed @ same time & also @ seperate times.
Our next mTNBC trial is now focused on PD-L1-negative patients.
So being a PD-L1-negative patients protocol
--- it would not make sense to extend out the ICI dosing in this trial.
Everything reads like our PoC protocol will now be LL/ICI combo for the metastatic subtype tumors.
Going to be an interesting protocol & reads like it is good odds the LL/ICI combo will be implemented early, like many have debated.
They're covering every base for Leronlimab & for that potentially significant partnership Dr. J referenced about in the past.
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