Genentech releases Phase III data for non-Hodgkin's lymphoma
Genentech and IDEC Pharmaceuticals have released data of a Phase III study in which Rituxan Plus CHOP induction therapy significantly prolonged time to treatment failure in newly-diagnosed patients
Genentech and IDEC Pharmaceuticals have released data of a Phase III study in which Rituxan Plus CHOP induction therapy significantly prolonged time to treatment failure in newly-diagnosed patients
The study was designed with two distinct randomisations: the first, called the induction phase, randomised patients to receive either six-to-eight cycles of cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) chemotherapy alone, or CHOP in combination with four-to-five doses of Rituxan. Patients who responded to Rituxan plus CHOP or CHOP alone in the induction phase were then randomised for a second time to receive either Rituxan maintenance therapy (four doses of Rituxan weekly, every six months for two years) or no further therapy (observation). For the analysis of the primary endpoint of the induction phase of the study - time to treatment failure (TTF) - the authors reported that patients who received Rituxan plus CHOP chemotherapy demonstrated a significant prolongation in TTF, as compared with patients receiving CHOP alone.
The addition of Rituxan to CHOP did not influence the overall response rate (ORR) in the induction phase. 'While we are encouraged by the preliminary data on time to treatment failure in the induction arm of the study, we believe that the maintenance information is currently immature and require more clinical events in patients to be available for analysis to further understand the results,' said Dr Susan Desmond-Hellmann, Genentech's executive vice president, development and product operations, and chief medical officer.
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, referred to as MabThera outside the US, in combination with CHOP chemotherapy, received European approval to treat aggressive NHL in March 2002. More than 300,000 patients have been treated with Rituxan worldwide.