CU6 clarity pharmaceuticals ltd

SECURE versus PSMAfore: How about complete responses?Trying to...

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    SECURE versus PSMAfore: How about complete responses?

    Trying to compare SECURE with PSMAfore is an interesting Olympic sport! I will try.

    1. SECURE is a dose determining study. In other words, we do not know what dosage to use (YET) in a future trial where 67Cu-Sar-bisPSMA will be evaluated versus SOC (including Pluvicto)! Any complete response is a bonus. Noone is about to run to the FDA to ask for 67Cu-Sar-bisPSMA approval based on that! We don't even know what dosage to use!
    2. As a safety focussed study, the sample size is deliberately small! Getting one complete response from such a small number is still a powerful message! Doing so before reaching the maximum dosing - something that dose expansion will/is investigating, is strong. The key here being that, safety opens up possibilities for more dosages: SECURE is a safety study. Effectiveness is a bonus.
    3. ALL of the patients in SECURE had failed multiple lines of therapy, including Pluvicto and even Alpha therapies in some cases! This is a safety determining study, so the people coming in are pretty desperate, with nothing else to use. A complete response means something very different in this group - unlike what it meant in PSMAfore.
    4. Moroever, PSMAfore EXCLUDED anyone who had previously used PSMA-targeted radioligand therapy or radionuclide therapy!

    -----
    Here (below) are PSMAfore inclusion and exclusion criteria!

    https://hotcopper.com.au/data/attachments/6813/6813417-ce66d355138b85c19d581735960be4ea.jpg


    https://hotcopper.com.au/data/attachments/6813/6813343-fb23d4f6d74a95f01515d0b27228cb49.jpg

    https://hotcopper.com.au/data/attachments/6813/6813439-f8d8340f182295c53147c19e0ce04eef.jpg

    https://hotcopper.com.au/data/attachments/6813/6813444-0b78705e15dc1a6db2fdb5d19a6b6dbb.jpg

    https://hotcopper.com.au/data/attachments/6813/6813446-c92f6eca2dd021cd1c46e0a395589335.jpg



    REFERENCES
 
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