Studies suggests that Rituxan prolongs remission in NHL

Biotechnology companies Genentech and Biogen IDEC have presented initial results from three trials involving the use of their therapeutic antibody Rituxan(rituximab).

A randomised Phase II study showed that patients with indolent non-Hodgkin's lymphoma (NHL) who received Rituxan maintenance therapy experienced 31 months of progression-free survival (PFS) as compared with eight months PFS for those patients who were retreated with Rituxan at the time of disease progression. The study also demonstrated that duration of Rituxan benefit, the primary endpoint of the study, can be prolonged by either maintenance therapy (31 months) or retreatment (27 months). The duration of Rituxan benefit was measured from the date of documented remission to the date that treatment other than Rituxan was necessary. Indolent lymphoma is a slow-growing, incurable disease in which the average patient survives between six and 10 years, following numerous periods of remission and relapse.

'The goal of treating patients with indolent lymphomas is to keep them disease-free and treatment-free for as long as possible. We are encouraged by these data, which indicate that patients whose response was maintained with Rituxan and those who were retreated numerous times with Rituxan were able to survive almost three years without undergoing chemotherapy,' said Dr Gwen Fyfe, Genentech's vice president of Clinical Hematology/Oncology.

A Phase III randomised study, evaluating Rituxan in combination with chemotherapy as a front-line treatment for aggressive lymphoma has met its pre-specified primary efficacy endpoint two years early. A pre-planned interim analysis of the study data by an independent Data and Safety Monitoring Committee (DSMC) demonstrated a statistically significant improvement in time to treatment failure (TTF) for patients receiving Rituxan and chemotherapy compared with chemotherapy alone. Based on the analysis, the DSMC has stopped further randomisation of patients on this study. The study enrolled approximately 800 patients and was conducted in 18 countries worldwide. 'We are particularly excited about these data as this is the first Rituxan-chemotherapy study in aggressive NHL to include patients younger than 60, said Fyfe.

Finally, Genentech and Biogen have announced initial positive results of the first randomized Phase III trial with Rituxan in previously untreated patients with indolent non-Hodgkin's lymphoma (NHL).

The results demonstrated that the addition of Rituxan to cyclophosphamide, vincristine, and prednisone chemotherapy (R-CVP) prolonged time to treatment failure (TTF), the primary endpoint of the study, to 26 months compared with seven months for patients treated with CVP alone. The risk of an event (defined as disease progression, relapse, death, stable disease after cycle four or new treatment administered) was reduced by 66% in patients who received R-CVP.

About Rituxan

Rituxan 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 defenses 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. Rituxan is indicated as a single-agent treatment for relapsed or refractory low-grade or follicular, CD20-positive, B-cell NHL. Rituxan is referred to as MabThera outside the United States. More than 300,000 patients have been treated with Rituxan worldwide.

About Non-Hodgkin's Lymphoma

There are more than 300,000 people in the United States with B-cell NHL. Approximately 50 percent have indolent or follicular lymphoma, while the other half are patients with aggressive NHL. Overall, NHL is the second fastest growing cancer in terms of incidence and deaths in the United States and is diagnosed in more than 56,000 men and women each year.