ESMO 2025 | CREST: immune-related adverse events with sasanlimab and BCG in NMIBC

Yeah, you know that CREST is a phase 3 trial which used the combination of sasanlimab, a subcutaneous PD-1 inhibitor, a combination of BCG, in non-muscle invasive bladder carcinoma in a high-risk situation. So that’s T1 high-grade, Ta high-grade, plus or minus CIS, a carcinoma in situ, and that this study was able to improve the event-free survival rate with the combination of sasanlimab plus BCG, the induction, and the maintenance. And it’s important to mention the maintenance because we learned that the full dose BCG regimen is necessary. Well, in our poster at this ESMO Congress, we had a more detailed look at the immune-mediated adverse events. And we combined all patients who have received sasanlimab because there were two arms, the BCG induction maintenance plus sasanlimab and the BCG just induction plus sasanlimab. And in this patient cohort, the aim of the poster was to give a detailed look at the immune-mediated side effects because the therapy and you know that BCG is often administered by the urologists and the outpatient practice by the catheterization and the instillation therapy to give a more detailed look and granularize that. What did we observe? So first of all I think the main and the important message is that the side effects which were observed for sasanlimab being a PD-1 antibody were just in line with what we know for the PD-1 immune checkpoint inhibition. So, there were no new safety signals observed. We had the classical spectrum of immune-mediated side effects. The rate in total was about 29% of grade 1 and 2 side effects. So, one of the messages and what we analyzed is that the majority of the side effects were cured within the first six months of treatment. So, of course, there were also spectrum and confidence intervals from the onset, early onset, late onset. But in the middle, it was more or less in the first six months. I think this is important for the clinical management of the patient because in the first six months, you have the patient more frequently due to the BCG induction. That’s weekly at the beginning and then the early maintenance start. And that, you know, well, if the patient has passed the first six months, it’s a rare event that then immune-mediated side effects can occur. On the other hand, the treatment discontinuation rate was about 13% to 16% interruption discontinuation of the Sansalimab. So you must, of course, be careful and monitor for these immune-mediated side effects. And then we also described the time to resolution. So the time to resolution was short. Patients needed that sometimes the glucocorticoids, also above the 40 milligram prednisolone equivalent threshold. But also the resolution was then after the onset within the first six months usually. So this is what was supposed to be about, so to granularize this immune-mediated side effect just to give a more detailed insight for the treatment management in the clinical routine.

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