Phase 3 study of Rituxan for the treatment of asymptomatic follicular lymphoma
Genentech and Biogen Idec announced positive data from a Phase 3 study of Rituxan (rituximab) in patients with advanced follicular lymphoma who did not have symptoms of disease (asymptomatic disease). This study was an international, multicenter, randomized, trial that enrolled 462 patients with previously untreated asymptomatic Stage II-IV follicular lymphoma. The trial compared the safety and efficacy profile of first-line induction followed by maintenance use of Rituxan alone (4 weekly doses followed by maintenance doses once every 2 months for 2 years) compared to careful observation (i.e., watchful waiting).
The Phase 3 results showed that immediate use of Rituxan monotherapy as induction followed by maintenance when compared to watchful waiting, decreased the risk of needing additional therapy by 80 percent (hazard ratio of 0.20, 95 percent CI, 0.13-0.29, p= <0.001) and decreased the risk of their disease worsening (PFS) by 79 percent (based on a hazard ratio of 0.21, 95 percent CI, 0.15-0.29, p= <0.001). The median time to initiation of new therapy (chemotherapy or radiotherapy) for patients managed by watchful waiting was 34 months and the median PFS was 23 months. However, in patients given immediate Rituxan followed by maintenance, the median of these parameters was significantly longer (p= <0.0001) and has not been reached after four years.
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