Phase III study showed Rituxan/MabThera decreased the risk of needing later treatment with chemotherapy or radiotherapy by 80% by Roche

Roche announced positive data from a Phase III study of Rituxan/MabThera (rituximab) in patients with advanced follicular lymphoma who did not have symptoms of disease (asymptomatic disease). Based on results of previous studies1 that showed no benefit of immediate chemotherapy after diagnosis, asymptomatic patients are managed by a “watchful waiting” approach and treatment for these patients usually does not begin until specific symptoms occur or their disease worsens. This study showed that immediate administration of single-agent Rituxan/MabThera (induction), followed by continued use of Rituxan/MabThera (maintenance) delayed the need for chemotherapy or radiotherapy and decreased the risk of the disease worsening (progression-free survival or PFS), compared to watchful waiting. The safety profile was consistent with previous experience with Rituxan/MabThera.

The data were featured today during a press briefing at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, FL. Full study results will be presented by Dr Kirit Ardeshna, M.D. today at 15:15 EST.

“We have found another way of managing this disease in its early years”, said Dr Kirit Ardeshna, University College Hospital, London, UK and Chief Investigator for the Watch and Wait trial. “For many patients it is important to delay the onset of chemotherapy and for them the results of this study is a great advance.”

The Phase III results showed that immediate use of Rituxan/MabThera monotherapy as induction followed by maintenance when compared to watchful waiting, decreased the risk of needing additional therapy by 80% (hazard ratio of 0.20, 95% CI, 0.13-0.29, p <0.001) and decreased the risk of their disease worsening (progression-free survival - PFS) by 79% (based on a hazard ratio of 0.21, 95% 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/MabThera followed by maintenance, the median of these parameters was significantly longer (p value of <0.0001) and has not been reached after four years. “These are the first Phase III data to have shown that initial use of Rituxan/MabThera monotherapy as induction followed by maintenance had an impact in patients with asymptomatic follicular lymphoma, a disease that is commonly treated only after symptoms appear,” said Hal Barron, M.D., Head of Global Development and Chief Medical Officer of Roche. “Early treatment interventions in prior studies in this population were not considered to provide meaningful clinical benefit. In this study, the use of Rituxan/MabThera delayed the need for additional treatment.” The data from the watch and wait study add to a growing body of evidence supporting Rituxan/MabThera induction and maintenance as an important strategy in follicular lymphoma. Rituxan/MabThera was recently approved in the EU for use in previously untreated patients who responded to induction therapy. The approval was based on results from the PRIMA study which included patients with advanced symptomatic follicular lymphoma, and showed that patients who continued Rituxan/MabThera therapy after having responded to initial Rituxan/MabThera plus chemotherapy had a nearly doubled likelihood of living without their disease worsening (PFS). Further data updates from the PRIMA study and another Rituxan/MabThera maintenance study called MAXIMA will also be presented at ASH.
About the “Watch and Wait” study

Sponsored by University College London Hospitals, this Phase III 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/MabThera alone (four weekly doses followed by maintenance doses once every 2 months for two years) compared to careful observation