I think you're spot on mfglola. I wrote Looking
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Posted On: 04/25/2025 5:21:35 AM
I think you're spot on mfglola.
I wrote Looking Forward 2 months ago on March 2, 2025.
That quote was from CytoDyn Announces Promising Survival Observations in mTNBC Patients Treated with Leronlimab
In the Key Takeaways portion of my post:
Considering Trodelvy is FDA approved in All mTNBC after 2 prior therapies and is therefore, 2nd line, while Keytruda is 1st line, only approved in about 33% mTNBC who are PD-L1 positive with a CPS > 10, like you mfglola, my gut is that Gilead wants to be included together with Merck's 1st Line Early Treatment, even if only for the 33% PD-L1+ w/ CPS>10. Gilead want to be a part of the First Line combination Trodelvy + Keytruda for any PD-L1+ mTNBC due to improved PFS .
Mrkev, I don't think leronlimab will have any problem increasing PFS beyond what the combination of Keytruad + Trodelvy could muster up together:
I wrote Looking Forward 2 months ago on March 2, 2025.
Quote:
Based on these survival observations, the Company has initiated two pre-clinical studies in mTNBC that will evaluate possible treatment synergies between leronlimab, an antibody-drug complex treatment (sacituzumab govitecan), and an immune checkpoint inhibitor (pembrolizumab). The Company will also continue to perform follow-up testing on the group of mTNBC survivors who currently identify as having no evidence of ongoing disease.
That quote was from CytoDyn Announces Promising Survival Observations in mTNBC Patients Treated with Leronlimab
In the Key Takeaways portion of my post:
Quote:
"Key Takeaways
Keytruda is used earlier (1st-line) in PD-L1-positive (CPS ≥10) mTNBC patients (~25–40%), offering a longer OS (23 months) and PFS (9.7 months) compared to chemo.
Trodelvy is used later (2nd-line or beyond) in all mTNBC patients , providing an OS of 11.8 months and PFS of 4.8 months, but still a significant benefit for those who progress after prior treatments."
Quote:
" Comparing leronlimab's assumed OS of 48 months in these patients with Keytruda's current OS of 23 months, (from table above), that would be a double or more. We might ask a question, Why is Keytruda's OS more than double Trodelvy's OS? (I just said, leronlimab's monotherapy OS = 48 months in May of 2025 is more than double Keytruda's OS. Why? Because leronlimab treats all MSS Type Tumors via CCR5 blockade.) From table above, Keytruda is only indicated to treat (PD-1+ with CPS >10) Tumors. This represents only 25-40% of all mTNBC tumors. (See the chart above.) In contrast, Trodelvy is indicated for all mTNBC Tumors, (regardless of PD1 and regardless of MSS or MSI Type), but requires at least 2 prior treatments for authorization. These PD-1+ Tumors, though they are mTNBC, they are in fact a fractional part of the 5% MSI Type Tumors and not a part of the 95% more typical MSS Type Tumors . So Keytruda really is just treating another MSI-H Type Tumor and that is why the OS for Keytruda is so high at 23 months. It is as if it is treating HR+ or HER2- Breast Cancer. Where as leronlimab's OS could be found to exceed twice Keytruda's OS and 4 times Trodelvy's, while leronlimab treats the more difficult MSS tumors .
What else would leronlimab add to Keytruda's list of deficiencies? The combination of (leronlimab + Keytruda) MOA could become CCR5 blockade + PD-L1 blockade, which could be superfluous. The FDA could approve All of mTNBC to the combination (leronlimab + Keytruda). The OS could likely exceed 30 months on average. PFS could exceed 20 months. "
Considering Trodelvy is FDA approved in All mTNBC after 2 prior therapies and is therefore, 2nd line, while Keytruda is 1st line, only approved in about 33% mTNBC who are PD-L1 positive with a CPS > 10, like you mfglola, my gut is that Gilead wants to be included together with Merck's 1st Line Early Treatment, even if only for the 33% PD-L1+ w/ CPS>10. Gilead want to be a part of the First Line combination Trodelvy + Keytruda for any PD-L1+ mTNBC due to improved PFS .
Mrkev, I don't think leronlimab will have any problem increasing PFS beyond what the combination of Keytruad + Trodelvy could muster up together:
Quote:
" After primary analysis of MicroNuclei MN formation MN presence based on numerous clinical variables, progression free survival (PFS) and overall survival (OS) outcomes were monitored for 36 months after the baseline blood draw. It was found that patients with MN in CAMLs had faster rates of progression, with MN presence associated with a median PFS of 5 months vs. a median PFS of over 36 months in patients without MN. Upon further analysis over 36 months, MN presence in CAMLs was found to be a significant predictor of PFS. In addition, it was observed that patients with MN CAML positivity had faster rates of mortality, with MN presence associated with a median OS of 7 months vs. a median OS of over 36 months in patients without MN. Similarly, MN presence in CAMLs was determined to be a significant predictor of OS over 36 months.
Patient B had an initial blood draw with high numbers of MN (3.1 MN/CAML) and had progressive disease while on FOLFOX. A new single agent CCR5 inhibitor, leronlimab, was started which coincided with a dramatic drop in MNs after 1 cycle of therapy. After 4 cycles of therapy, a scan confirmed a partial response of −39% in all target lesions. Additional blood draws found an increase in MNs at cycle 6 and 7, which was then associated with an 11% increase from the prior scan. Based on the lesion increase, the patient was started on FOLRIRI along with leronlimab, which saw a MN drop to 0 MN/CAML and the patient was found to have stable disease, with no changes in lesions observed ."
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