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GRAVITAS-301: improved complete aGVDH response

Presented By
Prof. Robert Zeiser, University Hospital Freiburg, Germany
EHA 2020
Phase 3, GRAVITAS-301
Although GRAVITAS-301 missed its primary endpoint, post-hoc analysis showed a significant effect of itacitinib in complete response at day 28 in patients with treatment-naive acute graft-versus-host disease (aGVHD). Prof. Robert Zeiser (University Hospital Freiburg, Germany) presented the results and a post-hoc analysis from the phase 3 randomised, double-blind GRAVITAS-301 trail [1]. GRAVITAS-301 evaluated itacitinib, a JAK-1 inhibitor in combination with corticosteroids in patients with treatment-naïve aGVHD. The primary endpoint was improvement of overall response rate (ORR) at day 28. The key secondary endpoint was 6-month non-relapse mortality (NRM). Included were adult patients (n=439) receiving allogeneic haematopoietic stem cell transplant (HSCT) for a haematologic malignancy who developed grade II–IV GVHD per MAGIC criteria. Patients were stratified...

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