Rituxan rituximab: Phase III data

An international Phase III trial in 462 patients with previously untreated asymptomatic follicular lymphoma showed that induction therapy with Rituxan followed by Rituxan maintenance therapy met the primary endpoint of significantly increasing median time to initiation of new chemotherapy or radiotherapy compared to a watchful waiting approach in which chemotherapy was deferred until disease progression. Specifically, median time to initiation of new therapy has not been reached at 4 years in patients receiving Rituxan vs. 34 months for patients managed by watchful waiting (p<=0.0001). Rituxan also met the secondary endpoint of significantly increasing median progression-free survival (PFS) vs. watchful waiting (not reached at 4 years vs. 23 months, p<=0.0001). Additionally, Rituxan significantly reduced the need for additional therapy by 80% and the risk of disease worsening by 79% vs. watchful waiting (p<=0.001 for both).

Patients received weekly 375 mg/m 2 Rituxan for 4 weeks followed by no maintenance therapy, weekly 375 mg/m 2 Rituxan for 4 weeks followed by Rituxan maintenance therapy once every 2 months for 2 years, or were managed by watchful waiting. The Rituxan arm without maintenance therapy was discontinued 3 years after enrollment of the first patient due to evidence of Rituxan efficacy in the maintenance setting. Data were presented at the American Society of Hematology meeting in Orlando. ...