RAPPERSWIL, Switzerland, June 26, 2017 /PRNewswire/ --
- The 8-year follow-up results of a randomized phase 3 multicenter trial in adult patients with hematologic malignancies clearly showed more favorable results in the Grafalon® group
- Severe GvHD-free and relapse-free survival was 34% in the Grafalon® group versus 13% in non-Grafalon® group
- The probability of being alive and free of immunosuppressive therapy was 47% in Grafalon® group versus 11% in non-Grafalon® group
- Relapse mortality was not increased by Grafalon®, supporting the long-term safety of Grafalon®
Neovii is pleased to announce the publication of the long-term outcomes of a multicenter parallel-group randomized trial conducted in Europe and Israel. The study looked at patients after standard GvHD prophylaxis with cyclosporine A and methotrexate with or without Grafalon® (anti-human-T-lymphocyte immunoglobulin- ATLG) (60 mg/kg total dose) in adult patients receiving myeloablative conditioning prior to hematopoietic stem cell transplantation from matched unrelated donors. Published in the June edition of The Lancet Haematology, the results showed the probability of being alive and free of immunosuppressive therapy at 8 years was 47% in the ATLG group and 11% in the non-ATLG group.
"The significantly improved composite endpoint 'Severe GvHD free and relapse free survival' clearly indicates the impact of ATLG in the cure of patients without ongoing morbidity, which is the main aim of allogeneic stem cell transplantation. This is supported by the fact that the vast majority of patients alive after ATLG-containing GvHD prophylaxis are free of immunosuppressive therapy," said Professor Jürgen Finke, the principal investigator of the study and Deputy Head of the Department of Hematology and Oncology at the Faculty of Medicine and Medical Center at the University of Freiburg, Germany. Professor Finke is also Chairman of the German Stem Cell Transplant Working Group (DAG-KBT). He added, "The results clearly demonstrate the importance of ATLG administration in matched unrelated stem cell transplantation and will certainly influence decision-making and patient counselling in the long run."
Alexandre Sudarskis, CEO of Neovii, commented, "These ground-breaking results undoubtedly prove the long-term efficacy of Grafalon® administration as part of a myeloablative conditioning regimen." He added, "Neovii strives to better meet the needs of our patients and to improve their quality-of-life with our effective antibody therapies, allowing physicians to apply a safe and robust therapy." Neovii supports research and development activities in the fields of stem cell transplantation, solid organ transplantation, and immune and hemato-oncological disorders.
About the study
Prospective, multicenter, open-label, randomized, phase 3 study of Grafalon® comparing standard ciclosporin A and methotrexate containing GvHD prophylaxis. Patients were randomized to either receive or not receive Grafalon®. The study was conducted in 9 European countries and Israel in 31 study centers, enrolling 202 patients. Patients had acute leukemia or myelodysplastic syndrome or myeloproliferative disease in an early (n=107) or advanced disease status (n=94). After myeloablative conditioning, patients received transplantation of blood stem cells (n=164) or bone marrow grafts (n=37). Study results were published in 2009 and 2011.
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 immunoglobulin, 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 a patient-focused mission to develop and market novel life-transforming therapies. Neovii has been dedicated for over three decades to improving outcomes in transplantation medicine, hemato-oncological and immune disorders.
Neovii Pharmaceuticals AG global headquarters is in Rapperswil, Switzerland, with offices in Massachusetts, USA. Its biologics manufacturing facility is in Gräfelfing, Germany.
Neovii has a global reach with products sold in over 50 countries worldwide.
 Finke, Jürgen et al. Long-term outcomes after standard graft-versus-host disease prophylaxis with or without anti-human-T-lymphocyte immunoglobulin in haemopoietic cell transplantation from matched unrelated donors: final results of a randomised controlled trial. The Lancet Haematology, June 2017; 4(6):e293-e301.
 Finke, Jürgen et al. Standard graft-versus-host disease prophylaxis with or without anti-T-cell globulin in haematopoietic cell transplantation from matched unrelated donors: a randomised, open-label, multicentre phase 3 trial. Lancet Oncology, September 2009; 10(9):855-64.
 Socié, Gerard et al. Chronic graft-versus-host disease: long-term results from a randomized trial on graft-versus-host disease prophylaxis with or without anti-T-cell globulin ATG-Fresenius. Blood, June 2011; 117(23):6375-82.
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