Takeda Presents Vedolizumab Data For Preventing Graft-Versus-Host Disease In Stem Cell Transplant Patients

Takeda Pharmaceutical Co Ltd TAK announced late-breaking data from the Phase 3 GRAPHITE study presented at the 2023 Tandem Meetings.
GRAPHITE (vedolizumab-3035) Phase 3 study designed to evaluate vedolizumab as prophylaxis of intestinal aGvHD in participants who receive allo-HSCT as a treatment for a hematologic malignancy or myeloproliferative disorder from an unrelated donor
The study exhibited that vedolizumab achieved a statistically significant and clinically meaningful improvement in lower gastrointestinal (GI) aGvHD-free survival by Day 180 after allo-HSCT with no relevant differences in safety profile versus placebo.
The study met its primary endpoint, with vedolizumab achieving a statistically significant improvement in intestinal aGvHD-free survival versus placebo by Day 180 after allo-HSCT (85.5% of patients in the vedolizumab arm versus 70.9% in the placebo arm.
Statistically significant superiority of vedolizumab over placebo was also demonstrated for intestinal aGvHD-free and relapse-free survival and Grade C-D aGvHD-free (with any organ involvement) survival.
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