New results reveal MaaT013 (Xervyteg) achieved a one-year overall survival rate of 54% for the treatment of patients with refractory severe acute Graft-versus-Host Disease (aGvHD). 

The data was announced by biotechnology company MaaT Pharma at the American Society of Hematology (ASH) Annual Meeting and Exposition, currently taking place in Orlando, US. 

MaaT Pharma presented results from the ARES Phase III single-arm trial evaluating MaaT013 in aGvHD patients with gastrointestinal involvement following corticosteroid and ruxolitinib failure. The findings demonstrate the durable survival benefit in this patient population, known for extremely poor prognosis. 

“These results confirm that MaaT013 (Xervyteg) offers a durable clinical benefit for patients with GI-aGvHD who have exhausted all currently approved treatment options,” said Professor Florent Malard, Professor of Haematology at Saint-Antoine Hospital and Sorbonne University, and lead investigator of the ARES trial. 

“Achieving a 62% gastrointestinal response at Day 28, maintaining responses over time, and reaching a 54% one-year overall survival represent a meaningful step forward in addressing this critical unmet need.” 

MaaT013 is currently under review by the European Medicines Agency (EMA) following the submission of a marketing authorisation application in June 2025, with a decision expected in mid-2026. 

Bruno Quinney, Content Team, DDW