OTS - Long-term outcomes after standard graft-versus-host disease (GvHD) prophylaxis in hemopoietic cell transplantation from matched unrelated donors strongly support the use of Grafalon® (anti-human-T-lymphocyte immunoglobulin) as standard therapy
2017. June 26. 07:45
Rapperswil, 26 June, 2017 (APA/OTS) - 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[1] 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[2] and 2011[3].
About GvHD
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.
About Grafalon®
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. (continues)