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Graft-Versus-Host-Disease

About Graft-Versus-Host Disease

HSCT provides a potentially curative option for some types of cancer, but it comes with the risk of GVHD. GVHD occurs when the transplanted immune system attacks the recipient’s body and is the leading cause of non-cancer death in stem cell transplant recipients. Roughly half of HSCT recipients develop GVHD.

There are two kinds of GVHD, acute (aGVHD) and chronic (cGVHD). Onset of aGVHD is typically within the first 100 days post-transplant and occurs in 30 – 70% of transplant recipients. Half of those individuals will go on to develop cGVHD, and an additional 30 – 70% develop cGVHD independently.

A global Phase 3 clinical study comparing the efficacy and safety of itolizumab versus placebo as a first-line therapy for patients with Grade III-IV acute graft-versus-host disease (aGVHD) or Grade II aGVHD patients with LGI involvement, in combination with corticosteroids.

Clinical Study Overview

GVHD is the leading cause of non-relapse mortality in cancer patients receiving allo-HSCT, and its risk limits the number and type of patients receiving HSCT. GVHD results in high morbidity and mortality, with one year survival as low as 40%. There are no approved treatments for first-line aGVHD.

GVHD is caused by the activation and trafficking of pathogenic T cells, which then go on to attack healthy tissue. Itolizumab, which is designed to treat GVHD by preventing this aberrant T cell activity, is currently being evaluated in a clinical trial.