MaaT013 As Salvage Therapy in Ruxolitinib Refractory GI-aGVHD Patients
Summary
MaaT013 showed interesting results in steroids and ruxolitinib-resistant aGVHD patients with gut involvement (55% ORR at D28) and 47% and 39% OS at 6 and 12 months respectively (Malard 2020), therefore warrant being tested as salvage therapy in steroid and JAK inhibitors-resistant GI-aGvHD patients. Given the absence of an approved 3rd line strategy or 2nd line strategy in ruxolitinib intolerant patients and the extremely poor prognosis of these patients, who are mostly left with no viable therapeutic option, a single-arm open-label design was proposed.
Timeline
- Start
- 2022-03-25
- Primary completion
- 2024-11
- Completion
- 2025-11
Outcome
Met primary endpoint
release “positive topline results from the pivotal Phase 3 ARES Study evaluating MaaT013 in aGvHD. The study met its primary endpoint” maatpharma.com ↗
release “ARES Study evaluating MaaT013 (Xervyteg ® ) in aGvHD, meeting its primary endpoint with a significant gastrointestinal overall response rate at Day 28 of 62%” maatpharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MaaT013 | Other / unclassified | — | Rectal |