CU6 - General discussion, page-489

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!

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Here (below) are PSMAfore inclusion and exclusion criteria!














REFERENCES

• 177Lu-PSMA-617 vs. Androgen Receptor-directed Therapy in the Treatment of Progressive Metastatic Castrate Resistant Prostate Cancer (PSMAfore) https://clinicaltrials.gov/study/NCT04689828#participation-criteria
• 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE) https://clinicaltrials.gov/study/NCT04868604#participation-criteria
• SNMMI 2024: Phase 3 Trial of [177Lu]Lu-PSMA-617 in Taxane-Naive Patients with Metastatic Castration-Resistant Prostate Cancer (PSMAfore);