Roche, Genentech, Inc., and Biogen Idec have been informed that a US Eastern Cooperative Oncology Group (ECOG) phase III study (E1496) evaluating MabThera (rituximab) maintenance therapy in indolent Non-Hodgkin's Lymphoma (NHL) has met its pre-specified primary efficacy endpoint earlier than expected. A pre-planned interim analysis of the study data by an independent ECOG Data Monitoring Committee (DMC) demonstrated a statistically significant improvement in time to treatment failure for patients receiving MabThera maintenance therapy. Based on this analysis, the DMC has stopped further randomization of patients on this study.
"The positive outcome of this study is extremely encouraging and provides additional evidence that MabThera may significantly change the disease course of indolent NHL," said William M. Burns, head of Roche Pharmaceuticals Division.
"This is excellent news for patients with indolent NHL. This decision by the committee suggests that an entirely new treatment concept is on the horizon - the maintenance of the benefits of induction therapy - which until now has not been standard practice," said Dr. Stefan Manth, head of Roche Oncology.
The phase III study enrolled previously untreated patients with indolent NHL. All patients received a maximum of eight doses of induction therapy with cyclophosphophamide, vincristine, and prednisone (CVP). At the time that the study was stopped, 322 patients who responded or had stable disease following induction CVP chemotherapy had been randomized to receive either MabThera maintenance therapy or no further treatment. MabThera maintenance therapy consisted of four weekly doses of MabThera every six months for two years. In this study, time to treatment failure was evaluated as the time from randomization to the first failure, defined as documented disease progression or death.