MabThera First-line Treatment Helps Patients With Indolent Lymphoma Live Longer

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Cancer / Oncology
Article Date: 16 Dec 2006 - 5:00 PDT

email to a friend   printer friendly   opinions  

Roche has announced exciting results from a pivotal phase III study that has followed the outcome of patients with indolent non-Hodgkin's lymphoma (NHL) treated with MabThera over four years ago. The study has shown that eight cycles of MabThera (rituximab) added to chemotherapy significantly prolongs the life of patients when compared to chemotherapy alone in patients with follicular NHL, the most common form of indolent NHL. This study outcome, presented at the American Society of Hematology meeting in Orlando, Florida, is a major treatment milestone as prolonging survival is the ultimate goal for any cancer drug that is used to treat incurable diseases.

"These results represent a major advance in the treatment of indolent NHL," commented Dr Kevin Imrie, from Toronto-Sunnybrook Regional Cancer Center, a primary investigator of the study.

"This is clear evidence that the addition of MabThera to first line chemotherapy for patients with indolent NHL not only extends the time that patients are free from the disease, but actually lengthens patients' lives."

Non-Hodgkin's lymphoma (NHL) affects 1 million people worldwide. It is estimated that 360,000 people die each year from the disease.(1) Indolent NHL, representing about 45% of NHL patients, is a slow developing but serious cancer of the lymphatic system.

The study demonstrated that a combination of eight-cycles of MabThera plus CVP (cyclophosphamide, vincristine and prednisolone) increased overall survival at 53 months - 81% of patients treated with MabThera were still alive compared with only 71% of patients who had only received chemotherapy. These results reinforce the positive impact of MabThera in indolent NHL patients that has already been recognized from earlier study results.

###

About the study

The multi-centre, phase III randomised study involved 321 patients from 11 countries and compared a treatment regimen of MabThera plus CVP chemotherapy with CVP chemotherapy alone. Patients were previously untreated and were diagnosed with advanced stage, indolent (follicular) NHL. Of the 321 patients involved, 159 were randomised into the CVP chemotherapy group and 162 into the MabThera plus CVP chemotherapy treatment group.

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.

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).

Improved survival benefits and favourable pharmacoeconomic data support MabThera as standard of care for lymphoma patients

Two pharmacoeconomic analyses, presented today at the American Society of Hematology meeting in Orlando, have demonstrated that MabThera (rituximab) is a highly cost effective treatment for indolent non-Hodgkin's lymphoma (NHL).

The first study(1), based on an analysis from the UK of a global study, showed that the cost of MabThera as first-line treatment of indolent NHL fell well within UK cost effectiveness thresholds. Based on the study model, cost effective MabThera treatment resulted in an estimated increase of more than two years of life expectancy (9.4 vs. 7.2 years) and an increase in quality adjusted life years (QALYs) when compared to chemotherapy alone (5.7 vs. 4.5 years).

The second study(2) confirmed MabThera's cost effectiveness in maintenance therapy for patients with relapsed indolent NHL. The study was based on a Canadian pharmacoeconomic analysis of the European Organisation for Research and Treatment of Cancer (EORTC) 20981 trial, which demonstrated that MabThera maintenance therapy nearly halves the risk of death in patients when compared to observation. The pharmacoeconomic model showed that treatment with MabThera maintenance therapy was also highly cost effective, with an estimated increase both in overall survival (5.6 vs. 4.7 years) and QALYs (4.0 vs. 3.2 years) by almost a year, compared with chemotherapy alone.

"Rituximab maintenance therapy not only prolongs patients' lives, but has also been able to demonstrate that it does so in a very cost effective manner by Canadian standards," said Dr. Joseph Mikhael, Assistant Professor at the University of Toronto and co-author of the study. "With both improved survival and positive supporting pharmacoeconomics, I think a new standard of care has been set for these patients."

The studies reinforce the value delivered by MabThera when used both as first-line treatment and as maintenance therapy of indolent NHL.

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.(3)

References:
1 Lewis et al., ASH 2006, Abstract #345
2 Maturi et al, ASH 2006, Abstract #343
3 World Health Report 2000, World Health Organization, http://www.who.int.

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

Further Information:
- Roche in Oncology: PDF file
- Lymphoma
- The Lymphoma Coalition
- Cancer
- World Health Organization
- Roche

• Additional
• References
• Citations