Roche, Genentech, and Biogen Idec have informed that a study evaluating anti-cancer drug Mabthera (rituximab) in combination with chemotherapy in patients with aggressive non-Hodgkin's lymphoma (NHL) has been halted early as it has met its primary efficacy endpoint two years earlier than expected.

The MInT1 study, an international cooperative group phase III trial, evaluated Mabthera in combination with chemotherapy in patients below 60 years of age with aggressive NHL. A previous study has demonstrated survival benefit in patients over 60 years old. A pre-planned interim analysis of the study data by an independent Data and Safety Monitoring Committee (DSMC) showed a statistically significant improvement in time to treatment failure for patients receiving Mabthera plus chemotherapy. Based on this encouraging result, the DSMC has recommended that the study be halted and the data analysed in full.

"The fact that the MInT study was stopped two years earlier than planned gives great hope to younger (below 60 years) patients with this life-threatening form of cancer," said William M Burns, head of Roche Pharmaceuticals Division. "We have already seen from the GELA2 trial that elderly patients over 60 years achieved a significant survival benefit from eight cycles of Mabthera plus chemotherapy - initial findings indicate that patients in the MInT study are also significantly benefiting from Mabthera."

The phase III study was conducted in 18 countries3 and recruited previously untreated patients below 60 years of age with aggressive NHL. Patients were randomised to receive either Mabthera in combination with chemotherapy, or chemotherapy alone. At the time the study was stopped, 326 patients were analysed for treatment efficacy. In this study, time to treatment failure was evaluated as the time from randomisation to the first failure, defined as documented insufficient therapeutic response, disease progression or death.