GU Cancers 2026 | PRESERVE-006: Phase I trial of gotistobart and 177Lu-PSMA-617 in mCRPC

Here at this conference, we presented updated results of the combination and monotherapy data of gotistobart with Pluvicto. And the idea behind this trial is that gotistobart is a second-generation CTLA-4 binding antibody and based on preclinical data and now based on some clinical data, seems to be a more potent selective Treg depleter in the tumor microenvironment while preserving the Treg levels in the periphery. And so this seems to translate into a lower toxicity risk with this agent, and we think that that’s important because we think that by enabling the continued activity of CTLA-4 binding like we’ve seen with Ipilimumab without this high-grade toxicity that we could potentially bring this agent into the prostate cancer landscape and so what we showed in this updated phase one profile is continued good tolerability we did see immune-related adverse events, but they were thankfully not high grade, and thankfully we have not had any fatal events, which has been seen with Ipilimumab and other therapies in prostate cancer and has really been a major barrier to that combination. Here in the combination with Pluvicto, we did not see any synergistic toxicity or really additive toxicity. We saw the expected profile of Pluvicto and the expected profile of gotistobart. And we also updated the efficacy results in this conference. And we continue to see a good initial effect on PSA response in the combination compared to the monotherapy. Of course, the data does need to mature and we will present larger cohorts in subsequent conferences.

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