Genentech releases Phase III PRIMA study findings

Sep 17 2009

Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and Biogen Idec (Nasdaq:BIIB), today announced that a Phase III study (PRIMA) showed that patients with follicular lymphoma who continued receiving Rituxan® (rituximab) alone after responding to Rituxan and chemotherapy lived longer without their disease worsening (progression-free survival or PFS) than those who did not continue to receive Rituxan. Because PRIMA met its endpoint during a pre-planned interim analysis, the study was stopped early on the recommendation of an independent data and safety monitoring board. The safety profile of Rituxan observed in the study was consistent with that previously reported.

Genentech, Roche and Biogen Idec will discuss next steps for a potential new indication for Rituxan with the U.S. Food and Drug Administration (FDA) and European regulatory authorities. The full study results will be submitted for presentation at a future medical meeting.

“The primary treatment goal in follicular lymphoma is to extend the time patients live with their disease under control,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “PRIMA showed that the extended use of Rituxan helped patients live even longer without their disease advancing and we look forward to discussing these new data with the FDA.”

“With more than twelve years of experience, Rituxan has been shown to be effective across various types and stages of non-Hodgkin’s lymphoma and these results suggested an additional benefit of Rituxan in the maintenance setting,” said Greg Reyes, M.D., Ph.D., senior vice president, Oncology Research and Development, Biogen Idec.