EHA 2025 | Real-world ocular monitoring and safety of belantamab mafodotin monotherapy in RRMM

Belantamab came to the market some years ago, both in the US and in Europe. It was retracted from the market. It came to the market as a monotherapy in late line. Then a randomized trial versus pomalidomide was negative. It was retracted from the market, but now it comes back. It’s now approved in Europe and will be approved by the FDA. Belantamab mafodotin in combination with either pomalidomide-dex, and bortezomib-dex. So the reason this study has been done with this BEAM study which is looking at real-world data efficacy but mostly about ocular follow-up and toxicity. This is because it’s a very, it’s a drug with very few side effects. It’s very easily managed, very easily for the patient to tolerate. Except one thing, it’s quite common with ocular events, keratopathy, blurred vision. So the idea was to see in a real-world situation, based on the approval that was there some years ago, in the US with 184 patients and 84 patients in Europe, how that was followed up and what we saw of ocular adverse events and what was the consequence of that. The data when it comes to efficacy, PFS response rates are the same as we knew from before, so there’s nothing new there. The patients in Europe were prospectively included in this trial. Routinely based treatment, but a prospective follow-up and registration. In the US this was a flat iron database, a bit retrospective data. One of the big differences between Europe and US in this regard is that the US demands of the ophthalmology is to see the patient every cycle. In Europe this was just the first three or four cycles and then it’s just up to symptoms. What we see is that, first we see that the ocular events are as was in the trial, it’s nothing new when you see this in routine practice. But the other thing is that there was not a bigger problem in Europe than in US. And Europe was even prospectively followed patients. So it means that this very sort of intensive ophthalmological follow-up that is in the US every cycle, it’s probably not necessary. I don’t even think it’s necessary as in Europe when it was usually used for the three, four cycles. I think we will gradually go to a more symptom-based follow-up. So patients who have no problems with their vision can just be in contact with ophthalmologists when they get trouble. So because I think that’s important because having such frequent ophthalmologist evaluations is a hurdle because sometimes it’s not available and sometimes it’s insurance problems and whatever. So I think that’s good to see. I also think we will see less of this when we have less intensive schedule, but not by itself, which is what we will do now.

This transcript is AI-generated. While we strive for accuracy, please verify this copy with the video.