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EBMT 2026 | MaaT013 pooled allogeneic microbiotherapy in refractory GI acute GvHD: results of the ARES trial

Florent Malard, MD, PhD, Saint-Antoine Hospital and Sorbonne University, Paris, France, discusses the current management of acute graft-versus-host disease (aGvHD) and shares the final results of the Phase III ARES trial (NCT04769895) exploring the pooled allogeneic microbiotherapy MaaT013 in patients with refractory gastrointestinal (GI) aGvHD previously treated with systemic steroids and ruxolitinib. Dr Malard notes the encouraging sustained overall response rate (ORR) observed with this fecal microbiotherapy (FMT) product, and emphasizes the potential of MaaT013 as the new third-line treatment option in this patient population. This interview took place at the 52nd Annual Meeting of the EBMT in Madrid, Spain.

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Transcript

So during this EBMT in Madrid, I have the pleasure to present the results of the ARES pivotal study evaluating MaaT013, a new microbiotherapy during the presidential symposium. So this phase three pivotal study shows a high response rate being 62% overall response rate at day 28 for GI graft versus host disease. This is a truly impressive result because this study addressed the unmet need of GI graft versus host disease that fail steroids but also ruxolitinib...

So during this EBMT in Madrid, I have the pleasure to present the results of the ARES pivotal study evaluating MaaT013, a new microbiotherapy during the presidential symposium. So this phase three pivotal study shows a high response rate being 62% overall response rate at day 28 for GI graft versus host disease. This is a truly impressive result because this study addressed the unmet need of GI graft versus host disease that fail steroids but also ruxolitinib. So it was a third-line treatment and we achieved this 62% overall response rate. Most importantly, the response rate was sustained because patients remained in response at day 56 and also at three months, and it translated to a high overall survival for this patient that used to have a very poor and very dismal outcomes. 

So when we are going to the treatment of refractory graft-versus-host disease, so steroids is a standard first-line treatment. We have ruxolitinib that is now approved for the second-line treatment of graft-versus-host disease as a patient with GI, skin or liver graft-versus-host disease. For the third-line setting, we don’t have any treatment approved so far. So we have this very exciting result with MaaT013, this microbiotherapy in the third-line setting for patients with GI graft-versus-host disease and we show in the pivotal study the 62% overall response rate at day 28 that truly suggests that it may be the new third-line treatment for those patients to improve their outcomes.

 

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Disclosures

Honoraria: AstraZeneca, Bristol Myers Squibb (BMS), Jazz Pharmaceuticals, Merck Sharp & Dohme, Novartis, Priothera, Sanofi, Therakos.