Monday, Dec 7, 2009

Phase III Data Showed Rituxan Plus Chemotherapy Improved Survival in Patients With Most Common Form of Adult Leukemia

New Orleans -- December 7, 2009 --

Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), and Biogen Idec (Nasdaq: BIIB) today announced that three-year follow up of the pivotal Phase III CLL8 trial showed Rituxan plus fludarabine and cyclophosphamide (FC) chemotherapy helped patients in the trial with previously untreated chronic lymphocytic leukemia (CLL) live longer than FC alone. No new safety signals were observed and the safety profile was consistent with those previously reported for Rituxan. The data were presented today at the 51st Annual Meeting of the American Society of Hematology (ASH) in New Orleans.


"These data showed that at three years of follow up, more patients who received Rituxan with fludarabine and cyclophosphamide chemotherapy were alive compared with those who received the chemotherapy combination alone," said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. "This is important because CLL is incurable and potential treatment options that may help people live longer are needed."


New data from the Phase III CLL8 study showed that 87.2 percent of patients with previously untreated CLL who received Rituxan plus FC were alive after more than three years of follow up (37.7 months) compared to 82.5 percent of patients who received FC alone (p=0.012). The median survival has not yet been reached. Also at this time point (37.7 months), patients who received Rituxan plus FC had a median progression-free survival (PFS) of 51.8 months compared to 32.8 months for those who received FC alone (p0.001, HR=0.56).


"Rituxan was the first targeted B-cell therapy approved for cancer in the U.S. and these new data once again illustrate Rituxan's ability to improve patient outcomes," said Greg Reyes, M.D., Ph.D., senior vice president, Oncology Research and Development, Biogen Idec. "These three-year data are exciting for people living with CLL."


CLL8 Survival Results: First-Line Treatment with Fludarabine, Cyclophosphamide, and Rituximab Improves Overall Survival in Previously Untreated Patients with Advanced CLL: Results of a Randomized Phase III Trial on Behalf of an International Group of Investigators and the German CLL Study Group (Abstract #535) - Monday, December 7, 2009, 2:45 p.m. CST, Hall F

Sponsored by Roche and conducted by the German CLL Study Group, CLL8 was a global, multi-center, randomized, open-label, Phase III study that enrolled 817 patients with previously untreated (first-line) CD20-positive CLL. The primary endpoint for CLL8 was PFS and secondary endpoints were overall survival (OS), event-free survival, duration of response, response rate, complete response and toxicity. CLL8 evaluated Rituxan plus FC chemotherapy compared with FC chemotherapy alone and met the primary endpoint of improving PFS. The primary study analysis was reported at ASH 2008.


As previously reported, Grade 3 or greater adverse events occurred more frequently in the Rituxan plus FC arm, compared to the FC arm, in particular neutropenia, but this did not result in an increased infection rate. ?In CLL8, the most common adverse events that occurred more often in the Rituxan plus FC arm included blood and lymphatic system disorders, infections and neoplasms. Grade 3 or greater events that occurred more often in the Rituxan plus FC arm included hematologic toxicity (56 percent vs. 39 percent), neutropenia (34 percent vs. 21 percent) and leukocytopenia (24 percent vs. 12 percent).


CLL8 was one of two studies submitted for review by the U.S. Food and Drug Administration (FDA) in an application for a potential label for Rituxan plus FC in CLL. The companies are committed to making Rituxan plus FC an FDA-approved option for people with CLL.


About CLL
According to the American Cancer Society, CLL is the most common adult leukemia, accounting for one-third of all leukemia in the United States. Nearly 90,000 Americans are living with CLL and more than 15,000 new cases will be diagnosed this year. It is a slow-growing disease that occurs when too many abnormal white blood cells are found in the blood and bone marrow, making it difficult for the body to fight infection.


About Rituxan
Rituxan is a therapeutic antibody that binds to a specific protein called CD20 found on the surface of cancerous and normal B-cells. In non-Hodgkin's lymphoma (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. B-cells usually 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 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 NHL in combination with CVP chemotherapy.
  • Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent, after first-line CVP chemotherapy.
  • Previously untreated diffuse large B-cell, CD20-positive, NHL in combination with CHOP (or other anthracycline-based chemotherapy regimens).

Rituxan received FDA approval for RA in February 2006 and is currently indicated in combination with methotrexate for the treatment of adult patients with moderately-to severely active rheumatoid arthritis who have had inadequate response to one or more tumor necrosis factor (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 Safety
Rituxan therapy does involve risks. Life-threatening side effects related to Rituxan therapy include infusion reactions, 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, 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.


About Genentech

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, Calif. For additional information about the company, please visit http://www.gene.com.


About Biogen Idec
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis and rheumatoid arthritis. For product labeling, press releases and additional information about the company, please visit http://www.biogenidec.com.


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