Phase III Study Showed Patients Lived Longer Without Low-Grade Lymphoma Progressing When Rituxan Was Used First-Line for Maintenance
South San Francisco, Calif. and Cambridge, Mass. -- September 16, 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.
About Non-Hodgkin's and Follicular Lymphoma
An estimated 574,000 Americans have non-Hodgkin's lymphoma (NHL) and this year, more than 66,000 people will be diagnosed with the disease. Of those diagnosed with NHL, approximately 20 to 30 percent of patients have follicular lymphoma, a slow-growing (low-grade), but incurable form of the disease. Although follicular lymphoma progresses slowly, the median survival time is seven to 10 years.
Sponsored by the Groupe d'Etudes de Lymphomes de L'Adulte (GELA), PRIMA is an international, multicenter, randomized, Phase III clinical study that enrolled 1,200 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 were randomized to receive Rituxan alone, given once every two months for two years, or observation alone.
The primary endpoint of PFS was defined as the time from randomization to disease progression or death as assessed by the treating physicians and an independent review committee. Secondary endpoints included objective response rate, time to next treatment, event-free survival, overall survival and safety.
Rituxan is a therapeutic antibody that binds to a specific protein called CD20 found on the surface of cancerous and normal B-cells. In NHL and rheumatoid arthritis (RA), Rituxan works with the body's own immune system to eliminate marked CD20-positive B-cells. Stem cells (B-cell progenitors, those cells that give rise to B-cells) in bone marrow do not have the CD20 protein. Therefore, B-cells regenerate after Rituxan treatment and return to normal levels in about 12 months for most patients.
Rituxan, discovered by Biogen Idec, first received FDA approval in November 1997 for the treatment of relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent. It was also approved in the European Union under the trade name MabThera® in June 1998. Rituxan is also approved for the treatment of NHL for the following:
Previously untreated follicular, CD20-positive, B-cell non-Hodgkin's lymphoma in combination with CVP chemotherapy.
Non-progressing (including stable disease), low-grade, CD20 positive, B-cell non-Hodgkin's lymphoma as a single agent, after first-line CVP chemotherapy.
Previously untreated diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma in combination with CHOP (or other anthracycline-based chemotherapy regimens.
Rituxan received FDA approval for rheumatoid arthritis in February 2006 and is currently indicated in combination with methotrexate (MTX) to reduce signs and symptoms and to slow the progression of structural damage in adult patients with moderately-to severely-active rheumatoid arthritis who have had inadequate response to one or more TNF antagonist therapies.
Genentech and Biogen Idec co-market Rituxan in the U.S., and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.
Rituxan therapy does involve risks. Life-threatening side effects related to Rituxan therapy include infusion reactions and kidney and skin problems, and progressive multifocal leukoencephalopathy (PML, a rare condition that causes nerve damage within the brain). Serious side effects have occurred in patients treated with Rituxan including hepatitis B virus infections with related serious liver problems, other viral infections, heart problems, kidney failure, and stomach and bowel problems.
The most common adverse reactions observed in Rituxan-treated patients include fever, headache, chills and shakes, nausea, itching, hives, cough, sneezing, and throat irritation or tightness. These usually occur within 24 hours after the first infusion. Other common side effects include headache, nausea, upper respiratory tract infection, and aching joints.
For additional safety information, please see the full prescribing information, including Boxed WARNINGS and Medication Guide, at 1-800-821-8590 or visit http://www.gene.com.
â€¨Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a wholly-owned member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
About Biogen Idec
Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the development, manufacturing and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into advances in human healthcare. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.
This press release contains forward-looking statements regarding the use of Rituxan in NHL. These statements are based on the companies current beliefs and expectations. Factors which could cause actual results to differ materially from the companies current expectations include the risk that we may be unable to adequately address concerns or questions raised by the FDA or other regulatory authorities, that concerns may arise from additional data and that the companies may encounter other unexpected hurdles. Drug development and commercialization involves a high degree of risk. For more detailed information on the risks and uncertainties associated with the companies drug development and other activities, see the periodic and current reports that Biogen Idec has filed with the Securities and Exchange Commission. The companies assume no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.