More on Rituxan Maintenance Therapy

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

Longer

Main Category: Lymphoma / Leukemia News

Article Date: 27 Dec 2006 - 5:00 PST

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Blood / Hematology

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.

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.

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.wh