European study in patients with acute leukemia shows the inclusion of Grafalon® (anti T-lymphocyte immunoglobulin) in a conditioning regimen before stem cell transplantation from HLA-identical siblings results in a significantly lower incidence of chronic GvHD
European study in patients with acute leukemia shows the inclusion of Grafalon® (anti T-lymphocyte immunoglobulin) in a conditioning regimen before stem cell transplantation from HLA-identical siblings results in a significantly lower incidence of chronic GvHD.
Results of a European study, which was jointly funded by Neovii and the European Society for Blood and Marrow Transplantation, have just been published as a full manuscript 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.
The principal investigator of the study, Professor Nicolaus Kröger, Medical Director of the Department of Stem Cell Transplantation at the University Hospital Hamburg, Germany and Chair of the EBMT Chronic Malignancies Working Group commented “The results of our multicenter study significantly improved the outcome of leukemia patients receiving an allogeneic stem cell transplant from their HLA-identical sibling by reducing the risk of chronic GvHD without obvious risk of relapse, which improves the quality of life of our patients after the transplant and will change our daily practice.“
Alexandre Sudarskis, Chief Executive Officer of Neovii added “These landmark results demonstrate Grafalon’s ability to prevent GvHD after stem cell transplantation in HLA-identical siblings patients and are an important addition to the data from our robust phase 3 study in matched, unrelated donors. Neovii is focused on advancing the stem cell transplant field by conducting high quality studies. Given the unique immunologic properties of Grafalon and the multiple robust data sets demonstrating improved clinical results, physicians can feel confident in the clinical benefits Grafalon provides patients.”
About the study
Prospective, multicenter, open-label, randomized, phase 3 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 centers and enrolled 168 patients. Patients were randomized to either receive or not receive Grafalon®
Graft versus host disease (GvHD) is a serious, life threatening complication after allogeneic stem cell transplantation. It develops, when the new immune system, which arises from the transplanted stem cells (graft), attacks tissues and organs of the recipient (host). It can be classified as acute or chronic, depending on the time of occurrence and/or the pathology.
Grafalon® (formerly commercialized as ATG Fresenius), is a rabbit anti-human T-lymphocyte globulin, used as part of immunosuppressive regimens for the prevention of graft versus host disease in stem cell transplantation, prevention and treatment of rejection in solid organ transplantation or as immunosuppressive in the treatment of aplastic anemia (according to country specific approved indications). With more than 200,000 treated patients to date in more than 50 countries, Grafalon® enjoys worldwide recognition among solid organ and stem cell transplant teams and has transformed the way transplant teams manage the care of their patients around the world.
Neovii is an independent, dynamic and rapidly-growing global biopharmaceutical company with patient-focused mission to develop and market novel life-transforming therapies. Neovii has been dedicated for over three decades to improve the outcomes in transplantation medicine, hemato-oncological and immune disorders.
Neovii Pharmaceuticals AG global headquarters is in Rapperswil, Switzerland, with offices in Massachusetts, USA and its biologics manufacturing facility is in Gräfelfing, Germany.
Neovii has a global reach with products sold in over 50 countries worldwide.
For further information
For further information contact firstname.lastname@example.org or Neovii Pharmaceutical AG office on telephone +41 55 210 0500.
For details on the full publication visit http://www.nejm.org/
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