The EORTC 20981 (European Organisation for Research and Treatment of Cancer) trial results have shown that the chances of survival for patients suffering from one of the most frequent forms of lymphoma, indolent non-Hodgkin's Lymphoma (NHL) is improved considerably with two years of maintenance therapy with MabThera (rituximab). The trial showed that the risk of death is halved for patients who receive MabThera maintenance therapy, compared to those who receive no maintenance treatment, irrespective of their initial therapy. Based on this data, Roche will be filing for a label extension for MabThera maintenance therapy for patients suffering from indolent lymphoma with European authorities.

The outcome of the clinical trial was presented at the 47th annual meeting of the American Society of Haematology in Atlanta, USA. MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then recruits the body's natural defences to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months. More than 730,000 patients have been treated with MabThera worldwide to date.

In Western Europe alone, 20,000 people are newly diagnosed with indolent NHL every year, and around 40,000 are being treated for this disease. "We are conscious that these results open a new era in the management of indolent NHL. Maintenance therapy with MabThera showed unprecedented survival benefits in a serious cancer disease which is currently considered incurable,” said William M. Burns, CEO of the Pharmaceuticals Division at Roche.

Professor Marinus van overs from the Academic Medical Centre of the University of Amsterdam and lead investigator of the pivotal study said, "Our trial confirms that MabThera maintenance therapy is highly beneficial for all patients, including those who have already received MabThera as part of their initial therapy. Maintenance therapy with MabThera may well become the new standard of care for these patients."

MabThera maintenance therapy was applied as a single infusion of 375mg/m2 every three months over a period of two years. The primary endpoints were response rates and progression-free survival for the initial treatment phase and the maintenance phase of the study, respectively. The trial was performed in 130 centres in Canada, Australia, Netherlands, UK, Norway, Slovenia, Slovakia, Belgium, Hungary, South Africa, Sweden, New Zealand, Denmark, Egypt, France, Switzerland, Italy and Poland.