New Data From Largest-Ever Clinical Trials in CLL Show MabThera Enables Leukaemia Patients to Live Longer Without Their Disease Progressing

Basel, Switzerland (ots/PRNewswire) -

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BASEL, Switzerland, December 6 /PRNewswire/ --

- Abstract Numbers: 325 & LBA-1

BASEL, Switzerland, December 6 /PRNewswire/ --

- Pivotal Phase III Results Suggest MabThera is Set to Change the
Face of Chronic Lymphocytic Leukaemia Management

Significant new data from two pivotal phase III studies, to be
presented at the 50th Annual Meeting of the American Society of
Hematology in San Francisco this week, show that patients with
chronic lymphocytic leukaemia (CLL) treated with MabThera (rituximab)
in combination with chemotherapy live considerably longer without
their disease progressing, compared to patients treated with
chemotherapy alone. The results could pave the way to a new approach
to treating this incurable form of adult leukaemia.

The key results of the two studies are:

- Previously untreated patients: The CLL-8 study showed that at
two years, more than three quarters (76.6%) of patients on MabThera
plus chemotherapy lived without their disease progressing compared to
63.3 % of those treated with chemotherapy alone.

- Relapsed/refractory patients: The REACH study demonstrated that
with MabThera, patients who had relapsed lived an average 10 months
longer without their disease progressing compared to those receiving
chemotherapy alone (30.6 months vs 20.6 months).

"The positive results from both of these trials is very
encouraging news for patients suffering from a disease that remains
life-threatening and incurable ," said William M. Burns, CEO
Pharmaceuticals Division of Roche. "The outcome of these trials
clearly demonstrates the important role MabThera will have in the
treatment of this devastating disease."

"MabThera has already revolutionised the treatment of people
living with non-Hodgkin's lymphoma", said Professor Tadeusz Robak,
Medical University of Lodz, Poland, and principle investigator for
the REACH trial. "These results add to a growing body of evidence
that underscores the important role MabThera has to play in the
management of CLL, which currently remains a life-threatening and
incurable disease."

Professor Michael Hallek, University Hospital Cologne, Germany,
who led the German CLL Study Group (GCLLSG) in conducting the CLL8
trial said, "With new therapies emerging, the management of CLL is
set to change markedly, with physicians having more options and
greater treatment expectations for their patients. These data, which
come from the largest randomised clinical trials ever reported in
CLL, suggest that MabThera used in combination with chemotherapy has
the potential to become the new standard of care for CLL patients."

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 3 per 100,000, and is twice as common
in men compared to women. It mainly affects the elderly with 95% of
patients diagnosed after the age of 55. While CLL is generally
considered a disease that it is slow to progress, a significant
proportion of patients have rapidly progressing forms of the disease.

About CLL8

The CLL8 study is an international study and included 817
patients with CLL receiving first-line treatment. The study was
conducted at 191 study sites across 11 countries. In this randomized
study, patients received either MabThera in combination with
chemotherapy (fludarabine and cyclophosphamide) or chemotherapy
alone. The primary endpoint of the study was progression-free
survival. No new or unexpected safety signals were observed.

About REACH

The REACH study is a randomized international study that included
552 patients with relapsed or refractory CLL. It was conducted at 88
study sites across 17 countries. The study was set up to investigate
whether treatment of patients with relapsed or refractory CLL with
MabThera in combination with chemotherapy (fludarabine and
cyclophosphamide) was more beneficial than treatment with
chemotherapy alone. The primary endpoint of the study was to show an
increase in terms of median progression-free survival.

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

Further Information:

- Roche in Oncology:
http://www.roche.com/media/media_backgrounder/media_oncology.htm

- Lymphoma: http://www.lymphoma-net.org

- The Lymphoma Coalition: http://www.lymphomacoalition.org

- Cancer: http://www.health-kiosk.ch/start_krebs.htm

- World Health Organization: http://www.who.int

Roche Group Media Office
Phone: +41-61-688-8888/E-mail: basel.mediaoffice@roche.com
- Daniel Piller (Head)
- Alexander Klauser
- Martina Rupp
- Claudia Schmitt
- Elina Ämmälä

ots Originaltext: Roche Pharmaceuticals
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Contact:
Roche Group Media Office: Phone: +41-61-688-8888/E-mail:
basel.mediaoffice@roche.com, Daniel Piller (Head), Alexander Klauser,
Martina Rupp, Claudia Schmitt, Elina Ämmälä