My name is Dr. Paul Richardson and I am the clinical program leader and director of clinical research at the Jerome Lippert Multiple Myeloma Center at the Dana-Farber Cancer Institute in Boston, Massachusetts. And it's my pleasure to be talking to you here at the International European Hematology Association meeting. It's the 30th meeting in fact in Milan, Italy and there's a lot of myeloma here, which is very exciting and very appropriate given all the exciting recent advances. But I was asked to talk to you about several particular topics for today. And the first one I wanted to talk to you about was the successes that we're seeing around the use of the antibody drug conjugate, Bilanthamabmafidotin, which has been used in combination with Bortezomib in one trial, the Dream 7 study, and in combination with pomalidomide in the Dream 8 trial. And these results have both generated remarkable data showing clinical benefit for patients with relapsed refractory disease. Now it's important to note that Bilanthamabmafidotin, which is a so-called antibody drug conjugate, targets BCMA. But unlike the very potent platforms such as CAR-T treatments that target BCMA or bispecific therapies that target BCMA, it doesn't actually redirect T cells in the classic sense, but rather generates an immunogenic signal from the myeloma cell that enhances the ability of the body's immune system to eliminate the myeloma. It does so in two ways, one by engaging the cell at the level of the BCMA cell surface receptor and at the other level by delivering what's called a cytotoxic wartet, in this case, mafidotin, which triggers what we call immunogenic cell death. This of course allows the body's immune system and other mechanisms to eliminate the myeloma highly effectively. Now when you combine this with other drugs, this particular combination is really effective. And so we're very pleased to see the positive results of Dream 7 and Dream 8. And moreover, what we were very pleased to see is the very manageable safety profile in terms of ocular toxicity, which we've learned by reducing dose and extending interval to be able to make much less of an issue on the one hand, and on the other hand, enhance the efficacy of the combination approach. So we're very much hoping this will result in Bilanthamab's approval at the regulatory level later this summer, and at the same time, allow it to then be rapidly available to communities where I think in particular, my own view, is that this particular platform has real value as an important treatment option for our patients with relapsed refractory disease. Now you may say, well, wasn't this drug approved before and what happened to it? It was indeed approved through the accelerated approval pathway, but some of the initial phase three information that came through from the so-called Dream 3 study, whilst there were no major safety concerns of any kind, were little concerning for the actual primary efficacy of the drug, in other words, the endpoint of progression free survival. And because this endpoint wasn't met in that particular trial, there was concern that his efficacy may actually not have been what was expected. While Dream 7 and Dream 8 absolutely addressed that point and show very clearly the remarkable benefit to the drug. And so we're very pleased to see Bilanthamab being back and in that same context, very much hoping for a regulatory approval in the United States this year, recognising that there's been very favourable decisions already in Europe regarding its potential use.
HealthTree • July 7, 2025