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MabThera maintenance therapy dramatically improves survival for patients with lymphoma
Risk of death halved - Roche files label extension in Europe for maintenance therapy
12 December 2005 - Two years of maintenance therapy with MabThera (rituximab) dramatically improves the chances of survival for patients suffering from one of the most frequent forms of lymphoma, indolent non-Hodgkin’s Lymphoma (NHL). The trial showed that the risk of death is halved for patients who receive MabThera maintenance therapy, compared to those who receive no maintenance treatment, irrespective of their initial therapy. The outcome of the clinical trial was presented today at the 47th annual meeting of the American Society of Hematology in Atlanta, USA.
Based on this data, Roche will file today with the European authorities for a label extension for MabThera maintenance therapy for patients suffering from indolent lymphoma. In Western Europe alone, 20,000 people are newly diagnosed with indolent NHL every year, and around 40,000 are being treated for this disease.
“We are conscious that these results open a new era in the management of indolent NHL“, said William M. Burns, CEO of the Pharmaceuticals Division at Roche. “Maintenance therapy with MabThera showed unprecedented survival benefits in a serious cancer disease which is currently considered incurable.”
Professor Marinus van Oers M.D. from the Academic Medical Center of the University of Amsterdam and lead investigator of the pivotal study said: “Our trial confirms that MabThera maintenance therapy is highly beneficial for all patients, including those who have already received MabThera as part of their initial therapy. We have not seen such an impressive improvement in progression free and overall survival for indolent NHL in the last 30 years. Maintenance therapy with MabThera may well become the new standard of care for these patients.”
About the study
In the EORTC 20981 (European Organisation for Research and Treatment of Cancer) trial, 465 patients with relapsed and refractory indolent NHL were randomised to receive either 3-weekly cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy or MabThera plus CHOP as induction therapy. Responding patients were then again randomised to either MabThera maintenance, or observation (no further treatment).
MabThera maintenance therapy was applied as a single infusion of 375mg/m2 every three months over a period of two years. The primary endpoints were response rates and progression-free survival for the initial treatment phase and the maintenance phase of the study, respectively. The trial was performed in 130 centres in Canada, Australia, Netherlands, UK, Norway, Slovenia, Slovakia, Belgium, Hungary, South Africa, Sweden, New Zealand, Denmark, Egypt, France, Switzerland, Italy and Poland.
Results of the induction phase
The results of the induction phase of the trial showed that patients who received MabThera and CHOP (R-CHOP) had a significantly higher rate of complete remission than patients who received CHOP chemotherapy alone (29% vs 16%, p value <0.0001). Furthermore, MabThera and CHOP chemotherapy significantly increased progression free survival compared to CHOP chemotherapy alone (median progression-free survival of 33 months vs 20 months, p value 0.0003).
Results of the maintenance phase
Overall survival (% of patients alive at 3 years)
No maintenance Maintenance p value Risk reduction1
All patients 77% 85% 0.011 48%
CHOP subgroup 71% 82% 0.073 48%
R-CHOP subgroup 81% 88% 0.059 50%
1 Treatment effect of maintenance therapy – reduction in the risk of death
Median progression-free survival
No maintenance Maintenance p value Risk reduction2
All patients 15 months 52 months <0.0001 60%
CHOP subgroup 12 months 42 months <0.0001 70%
R-CHOP subgroup 23 months 52 months 0.0043 46%
2 Treatment effect of maintenance therapy – reduction in the risk of progression of the disease, relapse or death
About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma (NHL) affects 1.5 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. More than 730,000 patients have been treated with MabThera worldwide to date.
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 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.
All trademarks used or mentioned in this release are legally protected.
Further Information:
- Genentech
- BiogenIdec
- Roche in Oncology
- Lymphoma
- The Lymphoma Coalition
- Cancer
- World Health Organization
Helping to beat cancer
EDITORIAL - heraldnews@archant.co.uk
26 July 2007 - A MUM from Harlow will be joining other cancer survivors in a 24-hour run for charity.
Rachel Willis, 38, was diagnosed with non-Hodgkins lymphoma in 1981, but 25 years later is living a normal and healthy life looking after her two sons.
She is now looking forward to taking part in the Cancer Research UK Relay For Life at The Leventhorpe School in Sawbridgeworth.
"From day one, the support of family and friends helped me keep positive and helped me through each day," said Rachel.
"I am absolutely thrilled to be part of Cancer Research UK Relay For Life in Sawbridgeworth and I consider myself lucky I can walk the lap of honour with fellow cancer survivors and celebrate our achievements."
When Rachel was initially diagnosed she had been admitted to the Princess Alexandra Hospital in Harlow with suspected appendicitis, but was later found to have stage three non-Hodgkins lymphoma and was admitted to St Barts Hospital in London.
The run celebrates the lives of those who have survived cancer, remember those who have passed away and honour the courage of loved ones.
Chairman of Relay For Life in Sawbridgeworth, Lorraine Gunn, said: "We are delighted to have someone as positive as Rachel on board to lead the lap of honour.
"She is an inspiration to everyone who meets her.
"Many of us have been affected by cancer in some way and we welcome everyone from Sawbridgeworth to get involved and become part of Relay For Life which is truly a unique experience and 24 hours you'll never forget."
Rachel will take part in a lap of honour round the track at the school on August 18, there is a Candle of Hope ceremony at 10pm during which candles will be lit and placed round the track in memory or in celebration of loved ones.
If you would like more information call Lorraine Gunn on 01279 657719 or e-mail hallingburyhighflyers@ google.com
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