A Dana-Farber trial shows an antibody drug greatly reduces the risk of severe chronic #GVHD in patients undergoing allogenic stem cell transplant. Corey Cutler, MD, MPH, at #ASH23 .
Chronic graft versus host disease is one of the most important complications after allogeneic stem cell transplant. And currently, there's no standard way to try to prevent it. Although some strategies that we're using currently in the clinic may have an effect on chronic GVHD incidents. There's been seminal work that was done in the laboratory of Dr Jerry Ritz that demonstrated that B cells were important in the pathophysiology of chronic gvhd. And therefore, we designed a trial to try to deplete B cells before chronic gvhd occurred with a goal of prevention of steroid requiring chronic gvhd. We randomly assigned 180 subjects to either receive a B cell depleting antibody called TUUM or placebo. And at the end of 12 months, we were very delighted to see that the incidence of steroid requiring chronic graft versus host disease was significantly lower than the patient group that received the active study drug. This led to improved immune suppression, free survival. And we believe fewer adverse events related to the use of corticosteroids which are very difficult for our patients to tolerate after transplant. We were able to correlate biologic end points such as the development of antibodies against minor histocompatibility antigens. And this fit with our hypothesis that the B cell and the antibody producing B cell in particular was important in the pathobiology of chronic gvhd. In terms of what we're going to do with this data. We think actually that we can now safely administer this compound to patients who are receiving standard tacrolimus based immune suppression after transplants. And we hope that it will be adopted broadly.