We’re here at the EBMT 2026 annual meeting in this beautiful city of Madrid, and as you may guess, GVHD has been a key and very important topic in this meeting. And the good news is that we have a lot, a lot of new data, lots of novelties, whether it’s about acute GVHD or chronic GVHD.
When it comes to acute GVHD, I think the biggest highlight is the presentation from the presidential symposium by Professor Mallard and colleagues about the role of the microbiota, especially the drug called now Xervyteg or MaaT013 previously in steroid refractory, but also ruxolitinib refractory, acute GVHD patient with GI involvement...
We’re here at the EBMT 2026 annual meeting in this beautiful city of Madrid, and as you may guess, GVHD has been a key and very important topic in this meeting. And the good news is that we have a lot, a lot of new data, lots of novelties, whether it’s about acute GVHD or chronic GVHD.
When it comes to acute GVHD, I think the biggest highlight is the presentation from the presidential symposium by Professor Mallard and colleagues about the role of the microbiota, especially the drug called now Xervyteg or MaaT013 previously in steroid refractory, but also ruxolitinib refractory, acute GVHD patient with GI involvement. We know very well this is a population with a highly unmet need. We do not have any effective treatment in this setting until recently. We would usually use the so-called best available therapies, but usually they are very disappointing. Here, in this pivotal so called ARES study, the investigators included 66 patients with severe GI, acute GVHD. These are patients who received and failed corticosteroids, high-dose corticosteroids, but also ruxolitinib. And the good news is that using this microbiotherapy with MaaT013, which is an enema, it’s a pooled multi-donor preparation, which is scaled and transformed into a drug, actually, allows you to achieve more than 60% response, made almost majority of complete responses, but also VGPR, very good partial responses. And these responses, especially the CRs, are sustained in time because what we observe at day 28 is going to be sustained at day 56, and at the end of the day, this will translate into an overall survival advantage with more than 50% at one year. This is clearly transformative, and this is clearly bringing a new, effective, and safe treatment for those patients who, until recently, didn’t have many solutions. And hopefully, we will be able to use this microbiotherapy on a larger scale in the near future.
When it comes to chronic GVHD, we have also lots of innovations. In the last 10 years, we’ve seen the approval and advent of ibrutinib in the United States. Ruxolitinib is approved and available almost everywhere, and it is proving to be a great drug for, for instance, steroid refractory chronic GVHD. More recently, we have seen the approval in the United States and in many countries across the globe of the ROCK2 inhibitor, namely Belumosudil. And this ROCK2 inhibitor, Belumosudil, is proving to be highly effective in those patients who are refractory to corticosteroids, but also who are refractory to ruxolitinib. So this is bringing really an important, effective, but also easy-to-use, safe treatment oral drug to this population. We know very well that chronic GVHD patients are really suffering from physical disability. They have an altered quality of life, and at the end of the day, they will have a dismal outcome. So the advent of Belumosudil in this population is very welcome. We should not also forget, although this is not yet available in Europe, about axatilimab, which is approved in North America. And again, this is a very specific IV monoclonal antibody, which works very well against the fibrotic process involved in chronic GVHD. So in summary, you see things are moving forward in the right direction positively when it comes to acute, but also chronic GVHD. And I believe these are really good news for patients and for all of us involved in the field.
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