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| |  EBMT: MabThera (Rituximab) With Stem Cell And Bone Marrow Transplant Improves Outcome In Non-Hodgkin’s Lymphoma MAASTRICHT, THE NETHERLANDS -- March 26, 2001 -- Leading haematologists revealed data showing MabThera (rituximab) is a powerful addition to transplantation and high-dose chemotherapy in treating indolent (low-grade) non-Hodgkin’s lymphoma (NHL) and a form of NHL known as Mantle Cell lymphoma (MCL). Using MabThera both pre- and post-transplantation can result in clinical and molecular remission in MCL and indolent NHL with no additional adverse effects, according to research presented at the 27th annual meeting of the European Group for Blood and Marrow Transplantation (EBMT). "The introduction of MabThera into the transplantation setting is promising news in the treatment of indolent NHL," said Professor Anthony Goldstone, Professor of Haematology/Oncology, University College London and Chairman of the symposium. "Although medical advances in stem cell transplantation therapy have improved the management of NHL, efficacy of cancer cell purging, from both graft and patient may be a crucial area of development and research. It is encouraging to see that MabThera may have potential relevance to improving this situation. "We anticipate that other treatment approaches, such as the introduction of MabThera into the transplant setting, will eventually transform the management of patients with indolent NHL requiring transplantation, and possibly even provide a cure for some of these patients," added Professor Goldstone. The past decade has seen a steady increase in the incidence of NHL, which currently affects 4.5 million people worldwide. In Europe, the incidence of NHL continues to rise by approximately 4.2 percent each year. MCL has a mean survival duration of three to four years. MabThera purging of stem cell products increases disease-free survival. Recently, high-dose chemotherapy with stem cell transplantation has become an accepted treatment for a subset of patients with aggressive forms of NHL and is under investigation for indolent forms of NHL. However, the clinical outcome may be hampered by possible contamination of tumour cells within the stem cell harvest, which are then re-infused into the patient. MabThera offers the possibility of in vivo purging which allows reduction or elimination of tumour cell contamination of blood (by the stem cell transplant) and induces molecular remissions in blood and bone marrow. During today’s satellite symposium (on MabThera in indolent and aggressive lymphoma) researchers presented further data, including: Professor A. M. Gianni (Professor of Medical Oncology Milan University, Italy) and his team of researchers studied the role of MabThera in the management of untreated MCL or refractory, early relapsed follicular lymphoma, in 25 patients. The proportion of lymphoma-free harvests was 93 per cent in the group receiving MabThera, compared with 40 per cent in the control group and PCR-negativity (absence of cancer DNA) was achieved in all patients with MCL in the MabThera treated group. Dr N. Berinstein (Director, Advanced Therapeutics Program Toronto-Sunnybrook Regional Cancer Centre, Sunnybrook and Women’s College Health Sciences Centre, Toronto, Canada) demonstrated that MabThera was successfully used in the management of follicular NHL, as an ‘in-vivo’ purge that did not adversely affect the number of stem cells collected, time to engraftment, or packed red cell or platelet requirements after transplantation. All 18 patients in the study achieved a CR (Complete Response) or CRu (unconfirmed complete response). All have entered a molecular remission in the blood and bone marrow by six-months post-treatment, and only one patient relapsed. These results provide the basis for an ongoing randomised study of MabThera before and after transplantation in follicular lymphoma (EBMT LYM1). Researchers are studying MabThera alone and/or in combination with various forms of chemotherapy for potential use in the treatment of numerous malignant and non-malignant haematological B-cell disorders including, indolent NHL, aggressive NHL, Waldenstrom’s macroglobulinemia, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), multiple myeloma (MM), idiopathic thrombocytopenia purpura (ITP), rheumatoid arthritis and post-transplantation lymphoproliferative disorders.
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