Thank you for sharing, and it does appear and has been stated this was CYDYs intent with cancer as far as basket trial. This was mentioned even in the early Dr. Pestell days. I found it interesting that they were able to use the TNBC IND for this basket trial vs filing a new one and having to begin a completely new trial and IRB approval by filing it for all solid tumors. I didn't expect this, but was pleasantly surprised by how quickly they were able to get both of these approvals to move the trial forward!
Now, I am curious if there are additional cancers (non-solid tumor) that lero will benefit......possibly to a lesser degree due to degrees of CCR5 on and around the cancer. Maybe a medical guru is able to find data to confirm or deny whether leronlimab will be able to help with more than the 22 cancers currently noted? I guess I don't need to get ahead of myself, but I fully expect the MOA to be proven as it has shown in 100% of the patient results publish thus far.
One other note is while basket trial may seem like a difficult bar, I also think it is important to note that this is a relatively new concept as your article outlines with Keytruda being the first approval in 2017 and only 3 granted thus far. I haven't looked, but I doubt any of those other drugs are nearly as safe as lerolimab, so that is a huge advantage for CytoDyn even without unbelievable efficacy and high responder rate. PFS is the primary endpoint, but the surrogate endpoint data of reduced CTCs, Overall response rate (ORR), monitoring time to new metastasis (TTNM), Overall survival (OS), measuring PD-L1 in CTCs, metastatic tissue and immune cells such as CAMLs and correlate with therapeutic benefit, correlation between CCR5 expression (CTCs, CAMLs) and PD-L1 expression will help significantly (if positive) as this data is easily obtained to provide early scientific results (not subjective) to support the PFS primary endpoint.
Now, I am curious if there are additional cancers (non-solid tumor) that lero will benefit......possibly to a lesser degree due to degrees of CCR5 on and around the cancer. Maybe a medical guru is able to find data to confirm or deny whether leronlimab will be able to help with more than the 22 cancers currently noted? I guess I don't need to get ahead of myself, but I fully expect the MOA to be proven as it has shown in 100% of the patient results publish thus far.
One other note is while basket trial may seem like a difficult bar, I also think it is important to note that this is a relatively new concept as your article outlines with Keytruda being the first approval in 2017 and only 3 granted thus far. I haven't looked, but I doubt any of those other drugs are nearly as safe as lerolimab, so that is a huge advantage for CytoDyn even without unbelievable efficacy and high responder rate. PFS is the primary endpoint, but the surrogate endpoint data of reduced CTCs, Overall response rate (ORR), monitoring time to new metastasis (TTNM), Overall survival (OS), measuring PD-L1 in CTCs, metastatic tissue and immune cells such as CAMLs and correlate with therapeutic benefit, correlation between CCR5 expression (CTCs, CAMLs) and PD-L1 expression will help significantly (if positive) as this data is easily obtained to provide early scientific results (not subjective) to support the PFS primary endpoint.
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