Managing High-Risk NMIBC
Transcript: ALBAN trial and insights from ESMO 2025
Morgan Rouprêt, MD, PhD
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.
- Yeah, thank you for the question. Actually, in the Western world, the vast majority of the cases we diagnose with bladder cancer are localised disease, especially non-muscle invasive bladder cancer. So there is a big unmet need at this stage because the current standard treatment is transurethral resection of the bladder plus BCG intravesical as induction and maintenance. So the question which was addressed by ALBAN was whether or not the addition of a systemic treatment with immunotherapy was likely to decrease the number of recurrences from the disease and the progression to a muscle-invasive stage.
The key efficacy is based on the endpoints that were defined at the enrollment of the patient. So as I told you, two arms: one is TURBT BCG for one year. The other one is TURBT BCG plus systemic atezolizumab for one year. The primary endpoint was not met, which was EFS, event-free survival. And there was, as a ratio, close to one, which means that the addition of the systemic treatment did not bring any, I would say, optimization of the treatment in these patients.
There were as many recurrences in the experimental arm than that we saw in the regular arm and, on concerning the adverse event and the side effect, of course the toxicity was much higher in the arm taking the atezolizumab with serious side effects coming from Grade 3 and 4 side effects, which are depicted in the literature. I think that after the trial and the other trials that are released in the field, we need to discuss during the tumour board discussion for every patient diagnosed with non-muscle invasive bladder cancer, there may be room for systemic treatment but in a highly selected population. We need to look at the forest plot because there were three trials: our trial, which was negative, but another trial which was positive today. And when you look at the forest plot, you can see that in some population, the CIS, carcinoma in situ, there is a signal, a trend towards improvement.
So probably in the future we'll select based on the pathological assessment not only the patient with high-risk characteristic but the patient with CIS plus multifocality, for instance. And then you will see that probably this population is suitable for the systemic treatment. I don't know what the systemic drug that we should choose. What we can say today is BCG remains the standard as an intravesical drug. We have three drugs potentially on the market, atezo, and sasanlimab. The question is also the length of time that you take the drug because, in the previous trial, which was released early on, it was two years of systemic treatment, which means a lot for the patient in terms of side effects and acceptance.
Because if you look at the endpoint, the endpoint is not overall survival, it's EFS, which means that you have to balance the pain and the gain because side effect from toxicity from an ongoing treatment versus two or three more, I would say, surgical endoscopic TURBT; it has to be balanced in the discussion. So at the moment there is nothing telling us that we should pinpoint this drug among the other one. There is no way we can choose because there is no head-to-head comparison. But, as I said, there is a subset of the population which is likely to receive a systemic drug. ALBAN, CREST coming together a few months ahead of POTOMAC, we have three trials, meaning that we are now enrolling patient on a large scale in the field of non-muscle invasive bladder cancer. It's the next big thing in the field because it will be potentially a game changer as this is the population we treat in the UK, we treat in Western Europe, we treat in Canada, we treat in the United States.
And at the moment we were a bit orphan of clinical research. So it's probably a way to open the Pandora's box of clinical research. Is not so many answers that we have today, more question mark, but I think the research will be extremely active in the field within the next few years.
Developed by EPG Health. This content has been developed independently of the sponsor, Pfizer, which has had no editorial input into the content. EPG Health received funding from the sponsor to help provide healthcare professional members with access to the highest quality medical and scientific information, education and associated relevant content. This content is intended for healthcare professionals only.
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