ASCO 2025 | PRESERVE-006: gotistobart and 177Lu-PSMA-617 in pre-treated mCRPC

Yeah, so this was a study that was looking at the combination of a novel CTLA-4-binding antibody combined with lutetium PSMA-617 that we conducted and we led across the United States at approximately 20 sites. You know, the rationale for this study was actually a finding that radiation therapy seems to more significantly deplete effector T-cells, whereas regulatory T-cells are maintained in the tumor microenvironment. And so this immunotherapy agent has the capacity to deplete regulatory T-cells. And so that led to the rationale that this immunotherapy may potentiate the response to radiation therapy by creating a more effective anti-tumor immune microenvironment. And so that was the rationale. Of course, the safety was the key endpoint for the phase one that we presented. And we did find in the 24 patients treated, we were able to identify a phase two dose. We were able to identify quite a manageable safety profile from the dose that we found, which we chose to actually conduct the dose optimization. And so we’re moving forward with six milligrams per kilogram Q6 or three milligrams per kilogram Q4, which were both doses that did not have dose-limiting toxicities in the phase one study. We were anticipating, of course, immune-related adverse events with the CTLA-4 binding antibody, and we did observe those, but we did not observe severe unmanageable events, thankfully, and we’re excited to see the results of the phase two.

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