Investor Update
Basel, 12 December 2006
MabThera dramatically improves survival for first-line Non-Hodgkin Lymphoma patients
MabThera shown to be highly cost effective therapy for indolent NHL
Roche today announced exciting results from a pivotal phase III study that has followed the outcome of patients with follicular NHL, the most common form of indolent Non-Hodgkin’s Lymphoma (iNHL), treated with MabThera more than four years ago. The follow-up study1 has shown that eight cycles of MabThera (rituximab) added to CVP chemotherapy in first line treatment significantly prolongs the overall survival when compared to chemotherapy alone. This study outcome, presented at the American Society of Hematology (ASH) meeting in Orlando, Florida, demonstrates for the first time clinically significant survival benefit in iNHL patients after 1st line treatment with MabThera / CVP combination therapy .
"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.2 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 (HR=0.60). This is the fourth phase III trial demonstrating overall survival benefit in indolent NHL with different combinations of MabThera and chemotherapy.
The EU regulatory authorities approved MabThera in combination with CVP chemotherapy for the treatment of previously untreated patients with stage III-IV follicular NHL in 2004. The FDA approval for the same indication was received earlier this year.
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. Time to treatment failure was significatntly prolonged by more than 1.5 years: 26 months versus 7 months; freedom from treatment progression was nearly doubled: 27 months versus 15 months.
Pharmacoeconomic analyses shows MabThera cost effectivness
A pharmacoeconomic analysis, also presented today at the ASH meeting in Orlando, have demonstrated that MabThera (rituximab) is a highly cost effective treatment for maintenance therapy for patients with relapsed indolent NHL. The study3 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.
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 (www.roche.com).
Further Information:
- Roche in Oncology
- Lymphoma
- The Lymphoma Coalition
- Cancer
- World Health Organization
MabThera dramatically improves survival for first-line Non-Hodgkin Lymphoma patients
MabThera shown to be highly cost effective therapy for indolent NHL
Roche today announced exciting results from a pivotal phase III study that has followed the outcome of patients with follicular NHL, the most common form of indolent Non-Hodgkin’s Lymphoma (iNHL), treated with MabThera more than four years ago. The follow-up study1 has shown that eight cycles of MabThera (rituximab) added to CVP chemotherapy in first line treatment significantly prolongs the overall survival when compared to chemotherapy alone. This study outcome, presented at the American Society of Hematology (ASH) meeting in Orlando, Florida, demonstrates for the first time clinically significant survival benefit in iNHL patients after 1st line treatment with MabThera / CVP combination therapy .
"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.2 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 (HR=0.60). This is the fourth phase III trial demonstrating overall survival benefit in indolent NHL with different combinations of MabThera and chemotherapy.
The EU regulatory authorities approved MabThera in combination with CVP chemotherapy for the treatment of previously untreated patients with stage III-IV follicular NHL in 2004. The FDA approval for the same indication was received earlier this year.
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. Time to treatment failure was significatntly prolonged by more than 1.5 years: 26 months versus 7 months; freedom from treatment progression was nearly doubled: 27 months versus 15 months.
Pharmacoeconomic analyses shows MabThera cost effectivness
A pharmacoeconomic analysis, also presented today at the ASH meeting in Orlando, have demonstrated that MabThera (rituximab) is a highly cost effective treatment for maintenance therapy for patients with relapsed indolent NHL. The study3 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.
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 (www.roche.com).
All trademarks used or mentioned in this release are legally protected
.Note
to editors:
1 Marcus et al, ASH 2006, Abstract #481
2
Ferlay J, Bray F, Pisani P and Parkin D.M. GLOBOCAN 2002; Cancer Incidence, Mortality and Prevalence
Worldwide IARC CancerBase No. 5, version 2.0 IARCPress, Lyon, 2004.
3 Maturi et al, ASH
2006, Abstract #343
Further Information:
- Roche in Oncology
- Lymphoma
- The Lymphoma Coalition
- Cancer
- World Health Organization