MabThera Significantly Extends Survival And Cures More Patients With Aggressive Lymphoma Than Chemotherapy AloneSeven year follow up of pivotal trial confirms that more patients are alive today due to MabThera
BASEL, Switzerland, June 4, 2007-A follow-up analysis tracking the outcome of patients with aggressive non-Hodgkin's lymphoma (NHL) who were treated with the innovative cancer therapy MabThera (rituximab) over seven years ago has revealed exciting results (1).
This analysis of the original pivotal phase III study has shown that over half (53%) of the patients treated with MabThera were still alive after seven years compared with just over a third (36%) of patients who had received chemotherapy alone. This means that for every 100 patients with aggressive NHL, 17 more patients would be alive at seven years due to MabThera.
The analysis also demonstrated that more MabThera treated patients were in remission at seven years compared to chemotherapy alone, 52% vs. 29%. As remissions of greater than 5 years are generally considered to be a cure, this study clearly demonstrates that the addition of MabThera to treatment cures more patients with aggressive lymphoma than chemotherapy alone. These benefits are irrespective of age and are seen even in patients with high risk characteristics.
This study outcome, presented at the American Society of Clinical Oncology meeting in Chicago, highlights the impressive impact that MabThera is having on aggressive NHL, a disease in which it has already saved thousands of lives.
"This long-term analysis clearly demonstrates the benefits that MabThera, in combination with chemotherapy, provides to patients with aggressive lymphoma," commented Prof. Bertrand Coiffier, from the Centre Hospitalier Lyon-Sud, a primary investigator of the study. "Furthermore, the results confirm that the addition of MabThera to treatment is critical even for older patients as the benefits were seen in all age groups."
"MabThera continues to prolong and rebuild life for patients with aggressive NHL," said William M. Burns, CEO Division Roche Pharma. "Seven years after the GELA trial, over half of the MabThera patients are still alive, offering hope of a cure for thousands more."
Non-Hodgkin's lymphoma (NHL) affects 1 million people worldwide. It is estimated that 360,000 people die each year from the disease (2). Approximately 40% of NHL patients present with an aggressive form of the disease, which, if left untreated, is generally fatal within six months.
About the study The study was conducted at 86 centers in France, Belgium, and Switzerland. A total of 398 patients were enrolled between July 1998 and March 2000. Previously untreated patients with diffuse large-B-cell lymphoma, 60 to 80 years old, were randomly assigned to receive either eight cycles of CHOP every three weeks (197 patients) or eight cycles of CHOP plus rituximab given on day 1 of each cycle (202 patients). The primary end point in this study was event-free survival.
About MabThera MabThera 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.
MabThera is indicated for the treatment of indolent and aggressive Non-Hodgkin's Lymphoma. MabThera is known as Rituxan in the United States, Japan and Canada. To date, patients have received more than 1 million treatments with MabThera worldwide.
Genentech and Biogen Idec co-market MabThera 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 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, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at www.roche.com.
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Further Information: - Roche in Oncology: www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf - Lymphoma: www.lymphoma-net.org - The Lymphoma Coalition: www.lymphomacoalition.org - Cancer: www.health-kiosk.ch/start_krebs.htm - World Health Organization: www.who.int
Note to editors: (1) Coiffier, ASCO, TBD (2) Ferlay J, Bray F, Pisani P and Parkin D.M. GLOBOCAN 2002; Cancer Incidence, Mortality and Prevalence Worldwide IARC CancerBase No. 5, version 2.0 IARCPress, Lyon, 2004.
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Posted: June 2007