Press Releases

Four-year study shows MabThera first-line treatment helps patients with follicular non-Hodgkin’s lymphoma live longer

11th December 2006 - Results announced today demonstrate that the addition of MabThera (rituximab) to chemotherapy treatment in patients with follicular non-Hodgkin’s lymphoma (NHL), significantly prolongs survival1 - the ultimate treatment goal for any cancer drug.

Data presented at the 48th American Society of Hematology (ASH) Annual Meeting in Orlando today show that a combination of rituximab plus CVP (cyclophosphamide, vincristine and prednisolone) increased overall survival at four years, with 81% patients treated with rituximab and chemotherapy still alive compared with only 71% on chemotherapy alone.1

Lead Investigator of the study, Dr Robert Marcus, Consultant Haematologist at Addenbrookes Hospital, Cambridge commented, “These new data from the trial demonstrating a modest but definite improvement in overall survival are encouraging and suggest the addition of rituximab to CVP confers long-term benefit.  The observation that the median duration of remission has not been reached in patients receiving rituximab plus CVP who achieve a complete response suggests that such patients benefit from prolonged freedom from disease with this low intensity regimen.”

About the study
The multi-centre, phase III randomised study involved 321 patients from 11 countries and compared a treatment regimen of rituximab plus CVP chemotherapy, with CVP chemotherapy alone. Patients were previously untreated and were diagnosed with advanced stage, follicular NHL. Of the 321 patients involved, 159 were randomised into the CVP chemotherapy group and 162 into the rituximab plus CVP chemotherapy treatment group. Key findings of the study include:1

• Rituximab plus CVP increased overall survival at 4 years; 81% of patients treated with rituximab and CVP were still alive compared with only 71% of those who had received CVP alone
• Median time to disease progression or death (TTP) was significantly prolonged in patients treated with rituximab and CVP; 34 months compared with 15 months for patients receiving CVP alone
• Estimated disease free survival (DFS) at 4 years was 54% for patients receiving rituximab and CVP compared with 17% for those on CVP alone

Approximately 60,000 people in the UK currently live with NHL2 with 9,200 people being diagnosed each year3. The incidence of NHL has more than doubled since the 1970’s4 and is rising by 3-7% each year5. Follicular lymphoma accounts for approximately 1 in 4 of all cases6.

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For more information or to arrange interviews with a leading expert in NHL please contact:

Red Door Communications

Liz Adams

Telephone: 020 8392 8040

Email: ladams@rdcomms.com

Roche

Olivia Garbutt

Telephone: 01707 367842

Email: olivia.garbutt@roche.com

Notes to Editors

About Rituximab

• Rituximab is a therapeutic antibody that binds to the CD20 antigen – present 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.
• Rituximab is the world’s first licensed monoclonal antibody therapy for the treatment of non-Hodgkin’s lymphoma (NHL)
• Rituximab is generally well tolerated and does not cause the unpleasant side effects associated with chemotherapy such as nausea and hair loss
• Rituximab is currently approved for first-line use for patients with follicular NHL in combination with the CVP chemotherapy regimen and as a monotherapy for follicular NHL.  It is also approved for use as maintenance treatment in patients with relapsed or refractory follicular lymphoma and in combination with CHOP chemotherapy for patients with diffuse large B-cell NHL.
• The National Institute of Health and Clinical Excellence (NICE) has recently approved Rituximab for the treatment of follicular lymphoma NHL first line in combination with CVP7 

For further information about Rituximab, please refer to the SmPC which is available on our website: www.rocheuk.com

About Roche in the UK

Roche aims to improve people's health and quality of life with innovative products and services for the early detection, prevention, diagnosis and treatment of disease. Part of one of the world’s leading healthcare groups, Roche in the UK employs nearly 2,000 people in pharmaceuticals and diagnostics. Globally Roche is the leader in diagnostics, and a major supplier of medicines for the treatment of cancer, transplantation,  virology,  bone and rheumatology, obesity and renal anaemia. Find out more at www.rocheuk.com

References

1  Marcus RE et al. MabThera (rituximab) plus cyclophosphamide, vincristine and prednisone (CVP) chemotherapy improves survival in previously untreated patients with advanced follicular non-Hodgkins lymphoma (NHL). Abstract 481, presented at the American Society of Hematology (ASH), Orlando, December 9-12 2006

2  C4: Cancer opportunities in the New Millennium: SRI Consulting 2000

3  http://info.cancerresearchuk.org/cancerstats/nhl 

4  Cancer Research UK.  UK Non-Hodgkin lymphoma incidence statistics.  www.info.cancerresearchuk.org/images/excel/cs_nhl_f1.2.xls

5  Decision Resources 1999. Pharmacor Oncor NHL – Block, SE

6  http://www.cancerbackup.org.uk/Cancertype/Lymphomanon-Hodgkins/TypesofNHL/Follicular

7  NICE.  Rituximab for the treatment of follicular lymphoma.  NICE STA.  September 2006

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