ESMO 2025 | Current and novel treatment strategies for early bladder cancer

Yeah, the presentation was during the session, the educational session on bladder cancer. It was dedicated specifically to localized disease to see how we can optimize the management of early bladder cancer. And I was tasked to talk about the adjuvant setting, which means the post-operative setting. And it was really a very rich presentation because we had a lot of novelties, a lot of new data coming in a few years ago. And that’s what makes the landscape of treatment in the adjuvant setting very rich currently. Well, because a few years ago, we didn’t have options to suggest or to propose to patients who underwent radical cystectomy. So we had observation. Then when we saw that observation cannot be enough for the patients who are at high risk, like the pT3, pT4, or patients with positive disease. So we saw that there is a need to intensify the treatment to cure those patients. And here came the rationale behind chemotherapy or the adjuvant chemotherapy. And we should admit that the rationale behind chemotherapy in the adjuvant setting is less strong and less important than we see in the neoadjuvant setting where we have strong data with phase 3 positive with improvement of overall survival in the neoadjuvant setting. So we all admit that the neoadjuvant chemotherapy is much more the standard of care for high-risk bladder cancer. But then we still have some patients who underwent cystectomy up front or they have a high risk even after the neoadjuvant chemotherapy. And this is the rationale behind developing the immune checkpoint inhibitor and testing them in the post-operative setting. And the first standard as immunotherapy was with the nivolumab after the Checkmate 274 study, the phase three trial that showed the improvement in the primary endpoint, which was the disease-free survival, but also an important and strong trend in overall survival, which makes this immunotherapy standard of care in the adjuvant setting. Then, so we had also the KEYNOTE-564 trial with pembrolizumab, another anti-PD-1 that showed also an improvement in DFS in a phase three trial, but it was not enough to admit it and now to include it now integrated in the guidelines because we had not met yet the overall survival, which was also a co-primary endpoint. Very recently, we had also a lot of data about the patients who can benefit more from this immunotherapy. And that’s why we went deeply into the field of biomarkers like the ctDNA, for example. Well, between brackets, we should say also that we are in the area of perioperative treatment. So yeah, now we are talking about the adjuvant, but we should also remind that the perioperative treatment, after the NILE trial results, etc., is now a new standard of care.

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