Phase III PRIMA study data of Rituxan to be featured at 46th ASCO

May 21 2010

Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) today announced data from the Phase III PRIMA study. The data showed that continuing Rituxan^® (rituximab) for two years in patients who responded to initial treatment with Rituxan plus chemotherapy, doubled the likelihood of them living without their disease worsening (progression-free survival or PFS) compared to those who stopped treatment (based on a hazard ratio of 0.50, 95% CI, 0.39; 0.64).

“The study is important because in those people who continued Rituxan, the risk of the cancer progressing was half of the risk than in those people who did not receive maintenance Rituxan.”

The data were featured during an American Society of Clinical Oncology (ASCO) presscast today. The organization's 46^th Annual Meeting will take place from June 4 to 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 Rituxan, the risk of the cancer progressing was half of the risk than in those people who did not receive maintenance Rituxan."

Genentech, Roche and Biogen Idec recently submitted an sBLA (supplemental Biologics License Application) to the U.S. Food and Drug Administration (FDA) and an extension of the Rituxan Marketing Authorization Application to the European Medicines Agency (EMA) based on the PRIMA study data.

"The PRIMA study results add to the body of evidence supporting Rituxan in non-Hodgkin's lymphoma and emphasize the role Rituxan plays in helping people with this cancer that will most likely recur," said Greg Reyes, M.D., Ph.D., senior vice president, Oncology Research and Development, Biogen Idec. "We look forward to discussing these new data with the FDA and European regulatory authorities."

Follicular lymphoma is a type of slow-growing form of non-Hodgkin's lymphoma (NHL). According to the American Cancer Society, an estimated 574,000 Americans have NHL. Of those diagnosed with NHL, approximately 20 to 30 percent of patients have follicular lymphoma. In 2009, approximately 66,000 new cases of NHL were expected to be diagnosed in the United States.

PRIMA: Rituximab Maintenance For Two Years Significantly Improves the Outcome of Patients With Untreated High Tumor Burden Follicular Lymphoma After Response to Immunochemotherapy: Results of the PRIMA Study (Abstract #8004) - Saturday, June 5, 2010, 1:00 p.m. - 1:15 p.m. CDT, Room E354a

Sponsored by the Group d'Etudes de Lymphomes de L'Adulte (GELA), PRIMA is an international, multicenter, randomized, Phase III clinical study that enrolled 1,217 patients with previously untreated advanced follicular lymphoma. The study evaluated the efficacy and safety profile of maintenance Rituxan in patients who responded to initial treatment with Rituxan plus chemotherapy (induction treatment).

In the study, Rituxan plus either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), CVP (cyclophosphamide, vincristine, prednisone) or FCM (fludarabine, cyclophosphamide, mitoxantrone) chemotherapy was used as initial treatment. Patients who responded (1,018/1,217) were randomized to receive Rituxan alone, given once every two months for two years (maintenance), or observation alone.

The safety profile was consistent with those previously reported in pivotal studies of Rituxan alone or in combination with chemotherapy. Serious adverse events (Grade 3 or 4) were reported in 23 percent of patients who received Rituxan maintenance compared to 16 percent who did not, including low white blood cell (neutrophil) counts (4 percent vs. 1 percent) and infections (4 percent vs. 1 percent).