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New Data from Largest-Ever Clinical Trials in CLL Show Rituxan (Rituximab) Enables Leukemia Patients to Live Longer Without Their Disease Progressing


<< Pivotal phase III results suggest Rituxan is set to change the face of Chronic Lymphocytic Leukemia (CLL) management >>

MISSISSAUGA, ON, Dec. 12 /CNW/ - Significant new data from two pivotal phase III studies, were presented at the 50th Annual Meeting of the American Society of Hematology in San Francisco this week, showing that patients with chronic lymphocytic leukemia (CLL) treated with Rituxan (Rituximab) in combination with chemotherapy live considerably longer without their disease progressing, compared to patients treated with chemotherapy alone. The results could pave the way to a new approach to treating this incurable form of adult leukemia.

<< The key results of the two studies are as follows:

1. The CLL-8 study, with previously untreated patients, showed that:
- 13.3% more patients were living without their disease returning at two years compared to those treated with chemotherapy alone (76.6% vs. 63.3%)
- 95% of patients receiving Rituxan in combination with chemotherapy responded to treatment compared to 88% of patients receiving chemotherapy alone (p=0.001)
- 52% of patients receiving Rituxan in combination with chemotherapy experienced a complete response compared to 27% of patients receiving chemotherapy alone (p(less than)0.0001)
2. The REACH study, with relapsed/refractory patients demonstrated:
- PFS (progression-free survival) was prolonged by an average of 10 months (30.6 months vs. 20.6 months)
- Overall response rate (ORR) was higher (70% vs. 58%), due to superior complete response (CR) (24% vs. 13%) >>

Dr. Laurie Sehn, Medical Oncologist and Clinical Investigator, University of British Columbia, and Clinical Assistant Professor, BC Cancer Agency believes that the results from these studies are important for Canadians living with CLL. "The data presented at ASH from the CLL8 and REACH trials demonstrate a clinically meaningful benefit in progression-free survival following the addition of rituximab to chemotherapy in both the upfront and relapsed setting for CLL."

"Rituxan (MabThera) has already revolutionized the treatment of people living with non-Hodgkin's lymphoma," said Professor Tadeusz Robak, Medical University of Lodz, Poland, and principle investigator for the REACH trial.

"These results add to a growing body of evidence that underscores the important role Rituxan (MabThera) has to play in the management of CLL, which currently remains a life-threatening and incurable disease." Professor Michael Hallek, University Hospital Cologne, Germany, who led the German CLL Study Group (GCLLSG) in conducting the CLL8 trial said, "With new therapies emerging, the management of CLL is set to change markedly, with physicians having more options and greater treatment expectations for their patients. These data, which come from the largest randomized clinical trials ever reported in CLL, suggest that Rituxan (MabThera) used in combination with chemotherapy has the potential to become the new standard of care for CLL patients." CLL is the most common type of leukemia in adults, accounting for approximately 25-30% of all forms of leukemia.

Incidence of CLL in Western countries is around 3 per 100,000, and is twice as common in men compared to women. It mainly affects the elderly with 95% of patients diagnosed after the age of 55. While CLL is generally considered a disease that it is slow to progress, a significant proportion of patients have rapidly progressing forms of the disease.

About CLL8
The CLL8 study is an international study and 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 REACH study is a randomized international study that included 552 patients with relapsed or refractory CLL. It was conducted at 88 study sites across 17 countries. The study was set up to investigate whether treatment of patients with relapsed or refractory CLL with Rituxan in combination with chemotherapy (fludarabine and cyclophosphamide) was more beneficial than treatment with chemotherapy alone. The primary endpoint of the study was to show an increase in terms of median progression-free survival.

About Rituxan (MabThera)
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 defenses 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 is indicated for the treatment of patients with stage III and IV follicular non-Hodgkin's Lymphoma and patients with CD20 positive diffuse large B cell non-Hodgkin's lymphoma. Rituxan in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease-modifying anti-rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies. Rituxan is known as MabThera outside the United States, Japan and Canada. To date, more than 1.5 million patients have been treated with Rituxan (MabThera) worldwide. Hoffmann-La Roche markets Rituxan (MabThera) in Canada and globally, except for the United States (where it is co-marketed by Genentech and Biogen Idec) Japan and (where it is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd).

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007, sales by the Pharmaceuticals Division totaled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people.

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Posted: December 2008