Media Release
Basel, 4 June 2007
MabThera
Significantly Extends Survival And Cures More Patients With Aggressive Lymphoma than chemotherapy alone
Seven
year follow up of pivotal trial confirms that more patients are alive today due to MabThera
A
follow-up analysis tracking the outcome of patients with aggressive non-Hodgkin’s lymphoma (NHL) who
were treated with the innovative cancer therapy MabThera (rituximab) over seven years ago has revealed
exciting results1.
This analysis of the original pivotal phase
III study has shown that
over half (53%) of the patients treated with MabThera were still alive after seven years compared with
just over a third (36%) of patients who had received chemotherapy alone. This means that for every 100
patients with aggressive NHL, 17 more patients would be alive at seven years due to MabThera.
The
analysis also demonstrated that more MabThera treated patients were in remission at seven years compared
to chemotherapy alone, 52% vs. 29%. As remissions of greater than 5 years are generally considered to
be a cure, this study clearly demonstrates that the addition of MabThera to treatment cures more patients
with aggressive lymphoma than chemotherapy alone. These benefits are irrespective of age and are seen
even in patients with high risk characteristics.
This study outcome,
presented at the American Society of Clinical Oncology meeting in Chicago, highlights the impressive
impact that MabThera is having on aggressive NHL, a disease in which it has already saved thousands
of lives.
"This long-term analysis clearly demonstrates the benefits
that MabThera, in combination with chemotherapy, provides to patients with aggressive lymphoma,"
commented
Prof. Bertrand Coiffier, from the Centre Hospitalier Lyon-Sud, a primary investigator of the study.
"Furthermore, the results confirm that the addition of MabThera to treatment is critical even for
older patients as the benefits were seen in all age groups."
"MabThera
continues to prolong and rebuild life for patients with aggressive NHL," said William M. Burns,
CEO Division Roche Pharma. "Seven years after the GELA trial, over half of the MabThera patients
are still alive, offering hope of a cure for thousands more."
Non-Hodgkin’s
lymphoma (NHL) affects 1 million people worldwide. It is estimated that 360,000 people die each year
from the disease.2 Approximately 40% of NHL patients present with an aggressive
form of the disease,
which, if left untreated, is generally fatal within six months.
About
the study
The study was conducted at 86 centers in France, Belgium, and Switzerland.
A total of 398 patients were enrolled between July 1998 and March 2000. Previously untreated patients
with diffuse large-B-cell lymphoma, 60 to 80 years old, were randomly assigned to receive either eight
cycles of CHOP every three weeks (197 patients) or eight cycles of CHOP plus rituximab given on day
1 of each cycle (202 patients). The primary end point in this study was event-free survival.
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, metabolism and 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 employs roughly 75,000 worldwide 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 at www.roche.com.
All trademarks used or mentioned in this release are protected by law.
Further Information:
- Roche in Oncology
- Lymphoma
- The Lymphoma Coalition
- Cancer
- World Health Organization
Note
to editors:
1) Coiffier, ASCO, TBD
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.