Genentech, Biogen report Phase III study data of Rituxan in patients with advanced follicular lymphoma

Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) announced today positive data from a Phase III study of Rituxan (rituximab) in patients with advanced follicular lymphoma who did not have symptoms of disease (asymptomatic disease).

“Early treatment interventions in prior studies in this population were not considered to provide meaningful clinical benefit. In this study, the use of Rituxan delayed the need for additional treatment.”

Based on results from previous studies 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 (induction), followed by continued use of Rituxan (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.

The data were featured today during a press briefing at the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, Fla. Full study results will be presented by Kirit Ardeshna, M.D., today at 3:15 p.m. EST.

"These are the first Phase III data to have shown that initial use of Rituxan 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., executive vice president, Product Development and chief medical officer. "Early treatment interventions in prior studies in this population were not considered to provide meaningful clinical benefit. In this study, the use of Rituxan delayed the need for additional treatment."

The Phase III 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).

SOURCE Genentech, Inc.

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