Roche, Genentech and Biogen Idec announced results of a new phase III study that shows that treatment with eight cycles of Mabthera (rituximab) in combination with conventional chemotherapy significantly prolongs time to treatment failure compared to chemotherapy alone in patients with indolent non-Hodgkin's lymphoma (NHL).

Indolent NHL is a serious but slow developing cancer of the lymphatic system and patients are prone to relapse after treatment. According to the study presented at the American Society of Hematology (ASH) meeting, the combination of Mabthera plus CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy has been shown to keep indolent NHL patients free from treatment failure nearly four times longer than CVP chemotherapy alone (average of 26 months vs. seven months). This allows patients to remain free from recurrence of this debilitating disease for a significantly longer period of time.

"Mabthera may alter the natural history of indolent NHL, breaking the cycle of relapse and remission," commented William M Burns, head of Roche's Pharmaceuticals Division. "The combination of Mabthera and CVP chemotherapy offers many patients the potential to enter a state of durable remission."

The addition of Mabthera to CVP chemotherapy nearly doubled freedom from disease progression (27 months vs. 15 months). Additionally, more patients treated with the combination of Mabthera plus CVP chemotherapy responded to treatment, with the overall response rate being 81per cent, compared to 57per cent, and the complete response rate quadrupling to 41per cent, compared to 10per cent, for patients receiving CVP chemotherapy alone. The safety of both regimens was comparable with no significant toxicity due to MabThera.

"These results represent a very major advance in the treatment of indolent NHL," commented Dr Robert Marcus of Addenbrookes Hospital, Cambridge, lead investigator of the study." By every criterion of effectiveness that we have measured, they show that the time the patient is free of disease has been markedly increased by the addition of Mabthera to conventional chemotherapy. This is the first time that a non-toxic, well tolerated treatment has been added to chemotherapy with such a significant clinical benefit in this condition."

The multi-centre, phase III randomised study involved 321 patients from 11 countries and compared a treatment regimen of Mabthera plus CVP chemotherapy with CVP chemotherapy alone. Patients were previously untreated and were diagnosed with advanced stage, indolent (follicular) NHL. Of the 321 patients involved, 159 were randomised into the CVP chemotherapy group and 162 into the Mabthera plus CVP chemotherapy treatment group.