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

• Takeda Pharmaceutical Co Ltd (NYSE: 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.

• Price Action: TAK shares closed at $15.63 on Friday.

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