Pivotal Phase III study with MabThera reaches primary endpoint in first line treatment for patients with Chronic Lymphocytic Leukaemia
BASEL, Switzerland | January 25, 2008 | Roche announced today that their innovative biotech drug MabThera (rituximab) can significantly increase the time before the disease progresses in patients suffering from the most common form of adult leukaemia, Chronic Lymphocytic Leukaemia (CLL).
The pivotal CLL8 trial, initiated by the German CLL study group, successfully met its primary endpoint, by showing that patients treated with MabThera in combination with the current standard chemotherapy achieved a significant improvement in progression free survival, compared to patients treated with chemotherapy alone.
“The outcome of this trial represents an important advance in the treatment of this life-threatening disease, where there is currently a high unmet medical need, ” said William M. Burns, CEO Pharmaceuticals Division of Roche. “That the study reached its primary endpoint almost a year ahead of schedule indicates the important role MabThera will have in the treatment of CLL.”
Chronic Lymphocytic Leukaemia (CLL) is the most common type of leukaemia in adults, accounting for approximately 25-30% of all forms of leukaemia. Incidence of CLL in Western countries is around 2-4 per 100,000, and is twice as common in men as in women. It mainly affects the elderly with 95% of patients diagnosed after the age of 55. While CLL is generally considered an indolent disease, meaning that it is slow to progress, a significant proportion of patients have rapidly progressing forms of the disease.
This study will form the basis of the regulatory filing in the EU later in the year to extend the use of MabThera for the treatment of first-line CLL. Data from this trial will be submitted for presentation at upcoming international scientific meetings.
About the CLL8 study
The CLL8 study is an international study, initiated by the German CLL study group, and included 817 patients with CLL receiving first-line treatment. The study was conducted at 203 study sites across 11 countries. In this randomized study, patients received either MabThera in combination with chemotherapy (fludarabine and cyclophosphamide) or chemotherapy alone. The study aimed to show a 35% increase in progression free survival when the MabThera-based combination was used. The study will also explore the long-term efficacy and safety of MabThera in this patient population, as well as the rate of molecular remission, a predictor of long term outcome in CLL.
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 1 million 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 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, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invests approximately 7 billion Swiss francs a year in R&D. Worldwide, the Group employs about 75,000 people. For further information please visit www.roche.com.
All trademarks used or mentioned in this release are legally protected.
SOURCE: ROCHE
Post Views: 141
Pivotal Phase III study with MabThera reaches primary endpoint in first line treatment for patients with Chronic Lymphocytic Leukaemia
BASEL, Switzerland | January 25, 2008 | Roche announced today that their innovative biotech drug MabThera (rituximab) can significantly increase the time before the disease progresses in patients suffering from the most common form of adult leukaemia, Chronic Lymphocytic Leukaemia (CLL).
The pivotal CLL8 trial, initiated by the German CLL study group, successfully met its primary endpoint, by showing that patients treated with MabThera in combination with the current standard chemotherapy achieved a significant improvement in progression free survival, compared to patients treated with chemotherapy alone.
“The outcome of this trial represents an important advance in the treatment of this life-threatening disease, where there is currently a high unmet medical need, ” said William M. Burns, CEO Pharmaceuticals Division of Roche. “That the study reached its primary endpoint almost a year ahead of schedule indicates the important role MabThera will have in the treatment of CLL.”
Chronic Lymphocytic Leukaemia (CLL) is the most common type of leukaemia in adults, accounting for approximately 25-30% of all forms of leukaemia. Incidence of CLL in Western countries is around 2-4 per 100,000, and is twice as common in men as in women. It mainly affects the elderly with 95% of patients diagnosed after the age of 55. While CLL is generally considered an indolent disease, meaning that it is slow to progress, a significant proportion of patients have rapidly progressing forms of the disease.
This study will form the basis of the regulatory filing in the EU later in the year to extend the use of MabThera for the treatment of first-line CLL. Data from this trial will be submitted for presentation at upcoming international scientific meetings.
About the CLL8 study
The CLL8 study is an international study, initiated by the German CLL study group, and included 817 patients with CLL receiving first-line treatment. The study was conducted at 203 study sites across 11 countries. In this randomized study, patients received either MabThera in combination with chemotherapy (fludarabine and cyclophosphamide) or chemotherapy alone. The study aimed to show a 35% increase in progression free survival when the MabThera-based combination was used. The study will also explore the long-term efficacy and safety of MabThera in this patient population, as well as the rate of molecular remission, a predictor of long term outcome in CLL.
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 1 million 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 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, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invests approximately 7 billion Swiss francs a year in R&D. Worldwide, the Group employs about 75,000 people. For further information please visit www.roche.com.
All trademarks used or mentioned in this release are legally protected.
SOURCE: ROCHE
Post Views: 141
