Subcutaneous rituximab: Phase III data

Roche reported in its 2Q12 earnings that the open-label, international Phase III SABRINA (BO22334) trial in patients with previously untreated follicular NHL showed that 1,400 mg subcutaneous MabThera plus standard chemotherapy met the Stage 1 primary endpoint of non-inferiority to 375 mg/m 2 IV MabThera plus standard chemotherapy in the ratio of trough serum concentrations of the drug at day 21. Patients are receiving subcutaneous or IV MabThera plus CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or CVP (cyclophosphamide, vincristine and prednisone) chemotherapy. Patients who achieve a partial or complete response at week 24, the Stage 2 primary endpoint, will receive maintenance treatment every 8 weeks for 24 months. Stage 1 of the trial enrolled 127 patients, while Stage 2 is enrolling 280 patients. Roche expects to present full Stage 1 data in 4Q12. ...