Hoffmann-La Roche Canada
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Hoffmann-La Roche Canada

December 11, 2009 07:00 ET

Rituxan (rituximab) is the First Treatment to Show Improved Overall Survival in Previously Untreated Patients with Chronic Lymphocytic Leukemia

Updated study results show patients live longer than when treated with chemotherapy alone

MISSISSAUGA, ONTARIO--(Marketwire - Dec. 11, 2009) -

Editors Note: A video is included with this press release.

Roche (SWISS:RO)(SWISS:ROG)(OTCQX:RHHBY) announced today at the 51st Meeting of the American Society of Hematology (ASH) in New Orleans, LA (USA) that the pivotal Phase III study CLL8 showed that patients with previously-untreated chronic lymphocytic leukemia (CLL) survived their disease longer when treated with Rituxan (rituximab) compared to chemotherapy alone.

"Treatment with rituximab in the CLL8 randomized study has shown for the first time that a specific first-line treatment for CLL could improve overall survival," said Professor Michael Hallek, University of Cologne, Germany, who led the CLL8 trial for the German CLL Study Group (GCLLSG). "The results support the recommendation to use fludarabine, cyclophosphamide and rituximab (FCR) as standard therapy in physically fit patients with CLL."

New data from the Phase III CLL8 study showed that 84.1 percent of patients with previously untreated CLL who received Rituxan plus FC were alive after more than three years of follow up compared to 79.0 percent of patients who received FC alone (p equals 0.01). The median survival has not yet been reached. After more than three years of follow up, 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. No new safety signals were observed in CLL8 and safety was consistent with previous Rituxan experience.

The results of the CLL8 trial come on the heels of the recent Health Canada approval of Rituxan in combination with chemotherapy (fludarabine and cyclophosphamide (FC)) for use in patients with previously untreated chronic B-cell lymphocytic leukemia (Binet stage B or C).

"The CLL8 findings will make a great impact on the treatment of Canadian patients with CLL. The study establishes that FCR is a standard first-line treatment for fit patients with CLL," said Dr. Christine Chen, hematologist, Princess Margaret Hospital and Assistant Professor, University of Toronto.

"From a patient's perspective, this is the best news that has emerged in CLL. This data demonstrates overall survival which means improved quality of life and extension of life for Canadian patients like myself," said Elizabeth Locatelli, CLL patient and Executive Director of the CLL Patient Advocacy Group.

Chronic lymphocytic leukemia (CLL) is the most common form of adult leukemia in the Western world, with an incidence in Canada of 4.65/100,000. The incidence is higher in males (6.28/100,000) than females (3.34/100,000). The disease is rare in persons less than 30 years of age, and its incidence increases after age 40. In 50- to 54-year-olds, rates are lower at 4.43/100,000, but increase to 32.89/100,000 in 75- to 79-year-olds.(1)

About CLL8

The CLL8 study is an international study conducted by the German CLL Study Group and Professor Michael Hallek (Cologne, Germany) in collaboration with Roche. It included 817 patients with CLL receiving first-line treatment. The study was conducted at 191 study sites across 11 countries. In this randomized study, patients received either Rituxan in combination with chemotherapy (fludarabine and cyclophosphamide) or chemotherapy alone. The primary endpoint of the study was progression-free survival. No new or unexpected safety signals were observed.

The results of CLL8 were first presented in 2008 and showed that patients receiving Rituxan in combination with chemotherapy as first-line treatment lived an average of 40 months without their cancer progressing compared to an average of 32 months for patients receiving chemotherapy alone.

About Rituxan

Rituxan is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then recruits the body's natural defences to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.

Rituxan Approved by Health Canada

In Canada, Rituxan is approved for:

1. The treatment of patients with relapsed or refractory low grade or follicular, CD20 positive, B-cell non-Hodgkin's lymphoma.

2. The treatment of patients with CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.

3. The treatment of patients with previously untreated Stage III/IV follicular, CD20 positive, B-cell non-Hodgkin's lymphoma in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy.

4. The maintenance treatment of patients with follicular non-Hodgkin's lymphoma who have responded to induction therapy with either CHOP or CHOP plus rituximab.

5. In combination with methotrexate to reduce signs and symptoms in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more tumour necrosis factor (TNF) inhibitor therapies.(2)

Rituxan is known as MabThera in the European Union. To date, more than 1.5 million patients have been treated with Rituxan worldwide.

Genentech and Biogen Idec co-market Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information, visit www.roche.com.

(1) Public Health Agency of Canada. Cancer Surveillance Online. http://dsol-smed.phac-aspc.gc.ca/dsol-smed/cancer/index_e.html. Accessed August, 11, 2009.

(2) Rituxan Product Monograph, August 11, 2009

To view the accompanying video, please visit the following link: www.youtube.com/watch?v=rsqtS1KbjN8

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