Basel, 8 December 2003
Breakthrough
in Treatment of Indolent Non-Hodgkin's Lymphoma
Addition of MabThera to chemotherapy
allows patients to remain free from disease longer Roche,
Genentech and Biogen Idec today announced results of a new phase III study that shows that treatment
with eight cycles of MabThera (rituximab) in combination with conventional chemotherapy significantly
prolongs time to treatment failure compared to chemotherapy alone in patients with indolent non-Hodgkin’s
lymphoma (NHL). Indolent NHL is a serious but slow developing
cancer of the lymphatic system and patients are prone to relapse after treatment. According to the study
presented at the American Society of Hematology (ASH) meeting, the combination of MabThera plus CVP
(cyclophosphamide, vincristine and prednisolone) chemotherapy has been shown to keep indolent NHL patients
free from treatment failure nearly four times longer than CVP chemotherapy alone (average of 26 months
vs. seven months). This allows patients to remain free from recurrence of this debilitating disease
for a significantly longer period of time. “MabThera may
alter the natural history of indolent NHL, breaking the cycle of relapse and remission,” commented William
M. Burns, Head of Roche’s Pharmaceuticals Division. “The combination of MabThera and CVP chemotherapy
offers many patients the potential to enter a state of ‘durable remission’.” The
addition of MabThera to CVP chemotherapy nearly doubled freedom from disease progression (27 months
vs. 15 months). Additionally, more patients treated with the combination of MabThera plus CVP chemotherapy
responded to treatment, with the overall response rate being 81%, compared to 57%, and the complete
response rate quadrupling to 41%, compared to 10%, for patients receiving CVP chemotherapy alone. The
safety of both regimens was comparable with no significant toxicity due to MabThera. "These
results represent a very major advance in the treatment of indolent NHL," commented Dr Robert Marcus
of Addenbrookes Hospital, Cambridge, lead investigator of the study." By every criterion of effectiveness
that we have measured, they show that the time the patient is free of disease has been markedly increased
by the addition of MabThera to conventional chemotherapy. This is the first time that a non-toxic, well
tolerated treatment has been added to chemotherapy with such a significant clinical benefit in this
condition.” 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. Further supportive studies also presented
at ASH
This is one of a number of studies presented at the ASH meeting demonstrating
the potential benefit of adding MabThera to chemotherapy for previously untreated patients with indolent
NHL. Myron Czuczman, M.D. of Roswell Park Cancer Center, presented follow-up data from a single phase
II study of MabThera plus CHOP in 38 patients with indolent NHL. The data showed the median time to
disease progression was reached at nearly seven years (82.3 months) after nine years of follow-up. In
addition, Wolfgang Hiddemann, chairman of the German Low Grade Lymphoma Study Group (GLSG), presented
results from a prospective randomised phase III study where the addition of MabThera to CHOP chemotherapy
resulted in a significant increase of time to treatment failure compared to chemotherapy alone. 394
patients with follicular lymphoma, a subtype of indolent NHL, were included in this efficacy analysis.
About non-Hodgkin’s lymphoma
Non-Hodgkin’s
lymphoma is more common than leukaemia with 1.5 million people worldwide living with the disease. NHL
develops in lymphatic tissue, which is found in many areas of the body, including the lymph nodes, spleen,
thymus gland, adenoid, tonsils and/or bone marrow. 55% of patients have the aggressive form of the disease,
which, if left untreated, can be fatal within six months. The remaining 45% suffer from indolent, or
low-grade NHL, and of these cases, 70% are estimated to be follicular. Indolent non-Hodgkin’s lymphomas
divide slowly and multiply in the body, making initial diagnosis more difficult. Patients with indolent
NHL may live for many years with the disease, but standard treatments cannot cure the condition. Until
now, the treatment options for patients have been standard chemotherapy regimens such as Chlorambucil,
CVP or CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy, which have provided
limited efficacy. 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 as a single-agent treatment for relapsed or refractory indolent NHL, and received European
approval in March 2002 for the treatment of aggressive NHL in combination with CHOP chemotherapy. MabThera
is known as Rituxan in the United States, Japan and Canada. More than 300,000 patients have been treated
with MabThera worldwide to date. Genentech and BiogenIdec
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. Roche
in Oncology
Within the last five years Roche has become the world’s leading provider
of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes
an unprecedented three marketed products with survival benefit; Herceptin, MabThera and Xeloda, treating
a range of malignancies breast cancer, non-Hodgkin’s lymphoma and colorectal cancer. Other key products
include NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in
breast cancer and bone metastases patients, hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-induced
nausea and vomiting) and Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma).
Roche’s cancer medicines generated sales of 4.5 billion Swiss francs in the first nine months of 2003.
Roche’s products in development also promise survival benefit
with Avastin. In a pivotal Phase III study Avastin increased survival duration by 30% when combined
with first-line chemotherapy for patients with advanced colorectal cancer. Roche
is developing new tests which will have a significant impact on disease management for cancer patients
in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast,
stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue
to be the leaders in providing cancer focused treatments and diagnostics. Roche
Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development
sites (two in the US, UK and Switzerland). About
Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading
innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche
is number one in the global diagnostics market and is the leading supplier of pharmaceuticals for cancer
and a leader in virology and transplantation. As a supplier of products and services for the 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 employs roughly 65,000 people in 150 countries. The Group has alliances
and research and development agreements with numerous partners, including majority ownership interests
in Genentech and Chugai. About Genentech
Genentech
is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics
for significant unmet medical needs. Sixteen of the currently approved biotechnology products originated
from or are based on Genentech science. Genentech manufactures and commercializes 12 biotechnology products
in the United States. The company has headquarters in South San Francisco, California and is traded
on the New York Stock Exchange under the symbol DNA. About
Biogen Idec
Biogen Idec creates new standards of care in oncology and immunology.
As a global leader in the development, manufacturing, and commercialization of novel therapies, Biogen
Idec transforms scientific discoveries into advances in human healthcare. All
trademarks used or mentioned in this release are legally protected. Notes
to editors:
*Australia, Belgium, Brazil, Canada, France, Israel, Poland, Portugal,
Spain, Switzerland, U.K. References:
1.
Marcus R, Imrie K, Belch A, et al. Abstract #87. An International Multi-Centre, Randomized, Open–Label,
Phase III Trial Comparing Rituximab Added to CVP Chemotherapy to CVP Chemotherapy Alone in Untreated
Stage III/IV Indolent non-Hodgkin’s lymphoma. Annual meeting of the American Society of Hematology,
December 2003.
2. World Health Report 2000, World Health Organization, www.who.int. Links: |
 |
print this page