Roche Pharmaceuticals

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) -

    - For Non-US and Non-UK Media

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



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