Results from study of Grafalon (anti-human T-lymphocyte globulin) in Graft versus host disease published in NEJM-Neovii

Results of a European study of Grafalon (anti-human T-lymphocyte globulin), from Neovii, in Graft versus host disease (GvHD), have been published in the January 2016 edition of the New England Journal of Medicine. The results showed at 2 years: the cumulative incidence of chronic GvHD was 32.2% in the study group with Grafalon compared to 68.7% in the non Grafalon group. The rate of the composite endpoint of chronic GvHD free and relapse free survival at 2 years was significantly higher in the Grafalon group than in the group without (36.6% vs 16.8%).

There were no significant differences between the groups in rates of relapse, infectious complications, acute GvHD, or adverse events. Prospective, multicenter, open-label, randomized, phase III study of Grafalon as part of a conditioning regimen prior to transplantation of allogeneic peripheral blood stem cells from HLA-identical siblings. The study was conducted in 27 European centres and enrolled 168 patients. Patients were randomized to either receive or not receive Grafalon.