Takeda Pharmaceutical’s (NYSE:TAK) drug vedolizumab met the principle objective of a section 3 trial to stop intestinal acute graft-versus-host illness (aGvHD) in sufferers present process allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Vedolizumab is bought beneath the identify Entyvio, and its intravenous (IV) kind is permitted within the U.S. to deal with sure sufferers with ulcerative colitis (UC) and Crohn’s illness (CD). The drug is just not at present permitted to be used in aGvHD.
The section 3 trial, dubbed GRAPHITE, enrolled 333 sufferers who acquired both an intravenous infusion of vedolizumab 300 mg or placebo.
The Japanese drugmaker stated the trial met its important objective, with vedolizumab (85.5% of sufferers on the drug) attaining a statistically vital enchancment in intestinal aGvHD-free survival versus placebo (70.9% of sufferers) by day 180 after allo-HSCT.
Statistically vital superiority of vedolizumab over placebo was additionally seen for intestinal aGvHD-free and relapse-free survival by day +180, and for Grade C-D aGvHD-free (with any organ involvement) survival at Day +180, in response to the corporate.
Takeda added that treatment-related opposed occasions had been seen in 24.8% on placebo, in comparison with 28.4% on vedolizumab. Meanwhile, remedy associated severe opposed occasions had been reported in 8.5% of sufferers on placebo, in comparison with 6.5% on vedolizumab.
The commonest opposed occasions of particular curiosity had been hypersensitivity reactions (placebo 82.4%, vedolizumab 79.3%), severe infections (vedolizumab 74.0%, whereas 67.3% for placebo), and liver damage (41.8% for placebo, and 40.2% for vedolizumab).
“These results have advanced our understanding of vedolizumab, currently indicated for IBD, in another critical GI inflammatory condition,” stated Chinwe Ukomadu, head, Gastroenterology Therapeutic Area Unit at Takeda.
Intestinal aGvHD can happen after stem cell transplant when the immune cells of the donor (graft) think about the recipient’s physique (host) as overseas and assaults the organs and tissue.