In This Article:
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Efficacy, safety, and long-term follow-up data from 154 patients in the EAP in Europe further reinforce the excellent clinical profile of MaaT013 in GI-aGvHD.
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MaaT013 is a safe and effective treatment for refractory GI-aGvHD particularly in patients who previously received ruxolitinib.
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Long-term follow-up shows that the observed high response rates translate into a prolonged survival at 2 years.
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A pivotal Phase 3 trial evaluating MaaT013 (ARES trial - NCT04769895) in GI-aGvHD patients who previously received steroids and ruxolitinib has been completed in October 2024. Topline results are expected in January 2025; among the 154 patients in the EAP, 58 patients closely resembling the Phase 3 population have shown very promising results.
LYON, France, November 07, 2024--(BUSINESS WIRE)--Regulatory News:
MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to enhancing survival for patients with cancer through immune modulation, announced that updated results from its Early Access Program of MaaT013 in 154 patients with steroid-refractory (SR) or dependent (SD) gastrointestinal acute Graft-versus-Host Disease (GI-aGvHD) have been selected for poster presentation at the 66th American Society of Hematology (ASH) Annual Meeting. GI-aGvHD is a major cause of morbidity and mortality following allogeneic hematopoietic stem cell transplantation. These patients previously failed 1 to 6 aGvHD systemic treatment lines and most had grade III (47%) or IV (40%) aGvHD.
Robust response rates that translated in sustained survival and strong safety were observed following MaaT013 treatment, confirming its potential as a transformative therapy for GI-aGVHD patients in urgent need of novel therapies.
Efficacy data is summarized below (see here for full abstract):
Full patient cohort (n=154):
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The gastrointestinal overall response rate (GI-ORR) at day 28 was 51% with complete response (CR) occurring in 46 patients (30%). ORR considering all organs was 49% with CR occurring in 41 patients.
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Overall survival (OS) was 53% at 6 months, 47% at 12 months and 42% at 24 months, indicating long-term benefits survival. Importantly, OS was significantly higher in patients who responded to MaaT013 compared to non-responders (68% versus 24% at 12 months and 58% versus 24% at 24 months).
Subset receiving 2nd line ruxolitinib (n=58) resembling the population enrolled in the Phase 3 ARES trial:
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Compared to the full patient cohort, improved responses were observed. The GI-ORR was 59% at day 28 (CR 48%). ORR considering all organ was 55% (CR 43%).
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In line with the full patient cohort, OS was significantly higher in patients who responded to MaaT013 compared to non-responders (75% versus 11% at 12 months and 61% versus 11% at 24 months).