MabThera(REG) Helps Patients With Lymphoma Stay Symptom Free And Live Longer

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Blood / Hematology
Article Date: 27 Dec 2006 - 5:00 PDT

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A study published recently in Blood, the journal of the American Society of Hematology, has confirmed that patients who receive MabThera as maintenance therapy for lymphoma experience significantly longer remission and overall survival.

The German Low Grade Lymphoma Study Group (GLSG) trial, carried out in relapsed patients with one of two major types of lymphoma, follicular or mantle cell, compared the outcomes of patients treated with MabThera maintenance therapy versus observation, irrespective of their initial treatment at relapse. The final results of the study showed that 77% of patients who received MabThera maintenance therapy were alive after 3 years, compared to only 57% who were not receiving additional courses of MabThera. These impressive results confirm similar outcomes seen in other recent trials showing that MabThera maintenance therapy prolongs patients’ lives.

Furthermore, patients receiving MabThera maintenance therapy dramatically increased their time in remission. At the end of the study, median symptom free survival for MabThera maintenance patients had still not been determined as the patients were still in remission. Once determined, this prolonged period of remission will be compared to the remission of only 16 months seen in the observation patients. These latest data reinforce the importance of MabThera maintenance therapy in the treatment of lymphoma.

Martin Dreyling, M.D., lead investigator for the GLSG study, commented: “By demonstrating a significant extension of progression free survival in relapsed patients and trending towards an overall survival benefit, these results clearly indicate MabThera maintenance therapy should become a new standard of care for patients with relapsed indolent lymphoma.”

Non-Hodgkin’s lymphoma affects 1 million people worldwide. About 45% of NHL patients have the form of the disease, which while slow to progress, has no cure. NHL has grown in incidence by 80% since the early 1970s.[i]

About the GLGS study

The study involved patients with advanced stage relapsed or refractory follicular lymphoma and mantle cell lymphoma. The study design comprised of 4 courses of chemotherapy (Fluarabine, Cyclophosphamide, and Mitoxantrone (FCM) +/- Rituximab). Responding patients underwent a second randomization for Rituximab maintenance (4 weekly doses (375mg/m²/d) at three and nine months after the end of induction) or observation only. Randomization was stratified for histology, number of prior therapies (up to 2 lines vs. >2 ), induction (+/- R) and response (CR vs. PR). After improved response and survival rates in the R-FCM arm were observed in the initial 147 randomized patients, all subsequent patients received a combined immuno-chemotherapy induction.

About Non-Hodgkin’s Lymphoma

Non-Hodgkin’s lymphoma (NHL) affects 1 million people worldwide. Indolent NHL, representing about 45% of NHL patients, is a slow developing but serious cancer of the lymphatic system. It is currently considered incurable. NHL is one of the fastest growing cancers and has grown in incidence by 80% since the early 1970s.i

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 960,000 treatments with MabThera worldwide.

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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 a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries 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 (http://www.roche.com).

All trademarks used or mentioned in this release are legally protected.

Note:

i World Health Report 2000, World Health Organization, http://www.who.int.

Further Information:

- Roche in Oncology: PDF file

- Lymphoma: http://www.lymphoma-net.org

- The Lymphoma Coalition: http://www.lymphomacoalition.org

- Cancer: http://www.health-kiosk.ch/start_krebs.htm

- World Health Organization: http://www.who.int

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