Roche has been informed that a phase III study1 evaluating the use of MabThera (rituximab) in patients with relapsed indolent non-Hodgkin's lymphoma (NHL) has met its primary endpoints two years earlier than expected.
In the two-part trial, patients were randomly assigned to receive MabThera plus chemotherapy or chemotherapy alone as initial treatment, and responding patients were then randomly assigned to receive MabThera for two years as maintenance therapy, or no further treatment. A pre-planned interim analysis showed that MabThera was the best therapeutic option in both parts of the trial: MabThera plus chemotherapy was significantly more effective than chemotherapy alone as initial treatment, and patients subsequently treated with MabThera maintenance for two years had significantly better progression-free survival than those who received no further treatment.
"More than half of patients with relapsed indolent NHL are currently treated with chemotherapy alone. This large trial confirms that MabThera should be the standard of care for patients with relapsed indolent NHL" said William M. Burns, Head of Roche's Pharmaceuticals Division. "Moreover, this is the third study in indolent NHL to confirm the benefits of MabThera maintenance treatment. Due to these impressive results more patients will now benefit from MabThera for a longer time."
The Independent Data Monitoring Committee (IDMC) concluded that the trial met its primary endpoints (response rate and progression-free survival) earlier than planned. The IDMC recommended changing the objective of the trial to answer the question of whether MabThera maintenance therapy is beneficial for patients receiving MabThera plus chemotherapy as initial treatment. The trial in its original design was not powered to answer this question. Therefore, the trial protocol will be amended so that all patients receive MabThera plus chemotherapy as initial treatment, and responding patients then be randomly assigned to receive MabThera as maintenance therapy for two years, or no further treatment.