MabThera Maintenance Therapy Helps Non-Hodgkin’s Lymphoma Patients Live for Years Longer Without Their Disease Progressing

Long-term results from a phase III study highlight the beneficial role of MabThera in patients   with recurrent or resistant disease

BASEL, Switzerland, Dec. 9, 2008--Data presented at the 50th Annual Meeting of the American Society of Hematology (ASH) today confirmed that patients with recurrent or resistant follicular non-Hodgkin’s lymphoma (NHL) receiving MabThera maintenance therapy after initial treatment with (immuno) chemotherapy live almost 2.5 years longer without their disease progressing than those not receiving maintenance treatment, representing a threefold increase in progression-free survival time.

Six-year follow up results from a study conducted by the European Organisation for Research and Treatment Cancer (EORTC) study group, show that patients with recurrent or resistant follicular NHL who were given MabThera maintenance treatment after their initial treatment with (immuno) chemotherapy had a median response of 3.7 years compared to 1.3 years for those who did not receive maintenance treatment.  The results also indicate that patients treated with MabThera in combination with chemotherapy experience better complete response (CR) rates compared to patients treated with the chemotherapy combination cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP) alone (29% vs 16%).

“These results show that MabThera maintenance therapy can help patients with follicular NHL return to their ‘normal’ daily activities by offering years of extra time between relapses”, said Professor Marinus van Oers of the University of Amsterdam and lead investigator of the study.  “This is an important advance in the treatment of this still incurable form of NHL that will be welcomed by patients and physicians alike,” he added.

NHL affects one million people worldwide.  Follicular NHL, representing about 25% of patients, is a slow developing but serious cancer of the lymphatic system.  It is currently considered incurable.

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About the study
EORTC 20981 is a phase III study designed to evaluate the role of MabThera in the treatment of patients with relapsed and refractory follicular NHL during the induction and maintenance phases.  It provides a six-year follow up of the study that was originally published in Blood in November 2006.  At that time the median follow up had been 33 months.  The primary endpoints were response rate for the induction phase and progression-free survival (PFS) for the maintenance phase.  The study involved 465 patients during the induction phase (234 R-CHOP; 231 CHOP) and 334 patients during the maintenance phase (167 R; 167 observation).  The results show that patients treated with MabThera and CHOP induction therapy experience better complete response (CR) rates compared to patients treated with CHOP alone (29% vs 16%).  In addition, the results show that patients treated with MabThera during the maintenance phase experience improved PFS compared to patients observed (median 3.7 years vs 1.3 years).  While improved PFS with MabThera does not translate into statistically significant overall survival advantages, this may be explained by the fact that 41% of patients received MabThera as (part of) salvage therapy.  MabThera maintenance was also associated with a significant increase in grade 3/4 infections (9.7 % vs 2.4 %).  Only 4 % of patients had to discontinue maintenance because of toxicity (mostly recurrent infections).

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 patients with stage III and IV follicular non-Hodgkin’s Lymphoma and patients with CD20 positive diffuse large B cell non-Hodgkin’s lymphoma.  MabThera 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.  MabThera is known as Rituxan in the United States, Japan and Canada.  To date, more than 1.5 million patients have been treated 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, 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 totalled 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.  Additional information is available on the Internet at www.roche.com.

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

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

For more information, please contact:
Peter Bayliss
Roche
Mobile: +41 7957 25193
Email: peter.bayliss@roche.com

Amber Bradbury
Ketchum
Phone: +44 7793 681615
Email: amber.bradbury@ketchum.com

 

Posted: December 2008

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