Managing High-Risk NMIBC
Transcript: NMIBC trends and research at ESMO 2025
Félix Guerrero-Ramos, MD, PhD, FEBU
Interview recorded October 2025. All transcripts are created from interview footage and directly reflect the content of the interview at the time. The content is that of the speaker and is not adjusted by Medthority.
- And this is more regarding NMIBC. They are having two very important studies that have been presented. One of them is POTOMAC, which has confirmed, like the results by the current study, which was presented at the AUA in Las Vegas in May. And they have seen with, that the addition of durvalumab to BCG induction plus maintenance is better than BCG induction plus maintenance alone for high-risk non-muscle invasive bladder cancer patients.
The differences with CREST are basically that this is an intravenous infusion and it's only one year as compared to sasanlimab, which is subcu for two years. And it is funny that the hazard ratio is exactly the same. It is 0.68 for both trials. So both of them are positive. The thing is that, we have not seen in POTOMAC an advantage for those patients with CIS, which is strange because it was a very big difference in the CREST trial. Another trial presented here has been the ALBAN trial from the French group with one year of atezolizumab plus BCG versus one year of BCG. And this trial has been negative with the hazard rate of 0.98. So this is a negative trial as compared with the POTOMAC and the CREST. And finally we're presenting our poster on the biomarkers for SunRISe-1 one for BCG-unresponsive CIS patients. Efficacy rates are the same, 82.4 complete response rate with a significant duration of the response, over 50% at one year. But what we are seeing here is that we have analysed several genomic alterations. 83% of the patients presented genomic alterations, but none of them has been related with their response rate.
Regarding the translation of the studies presented here to the daily clinical practise, I believe that there would be a role now for immune checkpoint inhibitors with BCG induction plus maintenance in high-risk non-muscle invasive bladder cancer patients who are BCG-naive. However, we know that these states a significant toxicity and we should try to select these patients and see which groups of patients would be, could obtain the higher benefits of this. Probably we will see in the new updates in the guidelines, some kind of recommendation of this new therapy. But of course we have two positive studies. We have to weigh the benefits and the toxicity of these new therapies. For example, on Monday, my clinic, if I had everything available, I would inform my high risk patient, especially if it's a very high risk patient, that there is a possibility to treat with the BCG plus durvalumab, but there are certain risks and make the patient understand what the role of the IO is and all that. And then have shared decision between us together. Especially those trials for BCG-naive and BCG-unresponsive patients.
Curiously, as surprising has been the negative results of ALBAN compared with POTOMAC and CREST. So it might look like this is not a class effect, as we are used to say for immune checkpoint inhibitors, or it could be some differences in the design of the trial. So that has surprised everybody to have two positive and one negative trials so far. Again, I am very closely looking at the BCG results in those trials and BCG has performed really well, more than what was said before and more than the classical series. This could be impacted by two things. We have higher quality TURBTs since these studies were published like 30 years ago. We're administering BCG with induction plus maintenance. But of course I also believe there is a bias of those patients who receive BCG under a clinical trial who are more willing to complete the therapy and are better seen in a clinical trial and usually have less comorbidities and all that.
Regarding intravenous administration, TAR-200 as we representing the biomarkers, but is a really promising option, a new way to deliver drug and maintain a sustained delivery into the bladder. And what I am happy is that all these new studies are reporting about patient reported outcomes, quality of life and all that, which is not so common. But we do not only have to look at efficacy, but also the patient's performance under the therapy. As I was speaking with my colleagues some days ago, this is not like the goal, this is the beginning of a new era. So we have many challenges ahead and many things that might have or have to evolve and improve. For example, I think it is time already for clinical guidelines such as EAU guidelines to include these new therapies, maybe also TAR-200, even if we do not have EMA, AMA approval and all that.
We also have to take into account that we need to better select our patients. We are using staging, which is a very old, based only on clinical pathological features, and we need to integrate molecular biomarkers to better stratify the patients. Not only that, but also predictors of response. As I said in our poster that we're presenting about the biomarkers-targeted response in SunRISe-1 trial was negative, but the sample is very small and long only for BCG CIS patients. Maybe with the results of SunRISe-3 trial, which is a big phase three trial with over 1000 patients, we have a more significant sample to be able to find differences according to the biomarkers.
So for me, in the future, we need more involvement with the guideline, in the guidelines, with the new therapies, biomarker selection, and better patient classification.
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