Phase III Study Showed First-Line Maintenance use of MabThera Doubles Likelihood of People With Follicular Lymphoma Living Without Their Disease Worsening



Basel, Switzerland, May 20, 2010 (ots/PRNewswire) – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today data from the Phase III PRIMA study. The data showed that continuing MabThera (rituximab) for two years in patients who responded to initial treatment with MabThera plus chemotherapy, doubled the likelihood of them living without their disease worsening, known as progression-free survival (PFS), compared to those who did not receive maintenance. The study enrolled patients with previously untreated advanced follicular lymphoma. No new safety signals were observed in this study and the safety profile was consistent with previous experience with MabThera.

The data were featured during an American Society of Clinical Oncology (ASCO) presscast today. The organization’s 46th Annual Meeting will take place from June 4 – 8, 2010 in Chicago, with more detailed PRIMA results presented on Saturday, June 5.

“Follicular lymphoma is an incurable cancer that may return many times during a person’s life and require additional therapy,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Roche. “The study is important because in those people who continued MabThera, the risk of the cancer progressing was cut in half compared to those who did not receive maintenance MabThera.”

Results of the PRIMA study showed MabThera, when used as maintenance, doubled the likelihood of people with follicular lymphoma living without their disease worsening compared to those who stopped treatment (based on a hazard ratio of 0.50, 95% CI, 0.39; 0.64; p=

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