Rituxan increases time to initiation of new chemotherapy in asymptomatic follicular lymphoma
Rituximab [Rituxan or MabThera ], a chimeric monoclonal antibody targeting the CD20 antigen, increased the median time to initiation of new chemotherapy in asymptomatic follicular lymphoma that was previously untreated, compared to a watchful waiting approach in which chemotherapy was deferred until disease progression.
An international Phase III trial in 462 patients with previously untreated asymptomatic follicular lymphoma showed that 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. The difference was highly statistically significant (p≤0.0001).
Other confirmatory endpoints were met with statistical significance, such as increasing median progression-free survival (PFS) vs. watchful waiting (not reached at 4 years vs. 23 months,
p≤0.0001), and reducing the need for additional therapy by 80% and the risk of disease worsening by 79% vs. watchful waiting (p≤0.001 for both).
The study started with 3 arms: patients receiving 1) 375 mg/m2 Rituxan weekly for 4 weeks followed
by no maintenance therapy, 2) weekly 375 mg/m2 Rituxan for 4 weeks followed by Rituxan maintenance therapy once every 2 months for 2 years, or 3) watchful waiting. After three years of enrollment, the first arm [Rituxan arm without maintenance therapy] was discontinued because Rituxan with maintenance was effective.