Roche Pharmaceuticals

Largest-Ever Studies on Most Common Form of Adult Leukemia, Show Patients Treated With MabThera Live Longer Without Disease Progressing

    Basel, Switzerland, November 24 (ots/PRNewswire) -


    - Two Phase III Studies to be Presented at World's Major Hematology Meeting Prove MabThera's Benefits in Treating Chronic Lymphocytic Leukemia (CLL)

    Roche announced today that full results of the pivotal REACH trial will be presented as part of the late breaking abstract session at the forthcoming 50th Annual Meeting of the American Society Hematology (ASH), in San Francisco. The randomized phase III trial in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) successfully met its primary endpoint by showing that patients treated with MabThera in combination with current standard chemotherapy were able to significantly extend the amount of time they lived without their disease progressing, compared to patients treated with chemotherapy alone.

    Results of the REACH trial will follow less than one day after the presentation of another pivotal Phase III study - CLL8 - which shows that MabThera can significantly increase the time before the disease progresses in patients who have not previously received any other treatment. Together, the two studies provide the strongest evidence yet of MabThera's potential to treat this devastating form of blood cancer.

    MabThera will be the main attraction at the annual ASH meeting with more than 270 abstracts being presented covering important trials investigating its use in the treatment of CLL, follicular lymphoma, diffuse large B-cell lymphoma, and the bleeding disorder idiopathic thrombocytopenic purpura, among others. The wealth of new data confirms MabThera as the standard of care in haematological cancers, where it has already been used to treat over 1.5 million patients in its existing indications.

@@start.t1@@      Chronic lymphocytic leukemia
      Date/Time    Abstract Abstract Name
      08.12.2008, 325         Immunochemotherapy with Fludarabine (F),
      11:00                         Cyclophosphamide
                                        (C), and Rituximab (R) (FCR) Versus Fludarabine and
                                        Cyclophosphamide (FC) Improves Response Rates and
                                        Progression-Free Survival (PFS) of Previously
                                        Untreated Patients (pts) with Advanced Chronic
                                        Lymphocytic Leukemia (CLL)
      09.12.2008, LBA1        Rituximab, Fludarabine, and Cyclophosphamide (R-FC)
      07:30                         Prolongs Progression Free Survival in Relapsed or
                                        Refractory Chronic Lymphocytic Leukemia (CLL)
                                        Compared with FC Alone: Final Results from the
                                        International Randomized Phase III REACH Trial
      09.12.2008, 781         Genomic Aberrations, VH Mutation Status and Outcome
      08:00                         after Fludarabine and Cyclophosphamide (FC) or FC
                                        Plus Rituximab (FCR) in the CLL8 Trial
      08.12.2008, 326         Quantitative MRD Assessments Predict Progression
      11:15                         Free Survival in CLL Patients Treated with
                                        Fludarabine and Cyclophosphamide with or without
                                        Rituximab - a Prospective Analysis in 471 Patients
                                        from the Randomized GCLLSG CLL8 Trial
      08.12.2008, 330         Bendamustine in Combination with Rituximab (BR) for
      12:15                         Patients with Relapsed Chronic Lymphocytic Leukemia
                                        (CLL): A Multicentre Phase II Trial of the German
                                        CLL Study Group (GCLLSG)
      07.12.2008, 47          Rituximab and High-Dose Methylprednisolone for the
      17:30                         Initial Treatment of Chronic Lymphocytic Leukemia Is
                                        Associated with Promising Clinical Activity and
                                        Minimal Hematologic Toxicity
      Follicular lymphoma
      Date/Time    Abstract Abstract Name
      09.12.2008, 836         Rituximab Maintenance Treatment of Relapsed /
      08:00                         Resistant Follicular Non-Hodgkin's Lymphoma: Long-
                                        Term Outcome of the EORTC 20981 Phase III Randomized
                                        Intergroup Study
      07.12.2008  2599        Rituximab in Combination with CHOP in Patients with
      (poster                      Follicular Lymphoma: Analysis of Treatment Outcome
      Board                         of 552 Patients Treated in a Randomized Trial of the
      II-693)                      German Low Grade Lymphoma Study Group (GLSG) after a
                                        Follow up of 58 Months
      09.12.2008, 773         Autologous Stem Cell Transplantation (auto-SCT) as
      08:00                         the Treatment of Choice for Follicular Lymphoma
                                        Patients in First Relapse: Final Analysis of the
                                        Outcome of 175 Patients Treated in the GELA/GOELAMS
                                        FL 2000 Study
      Diffuse large B-cell lymphoma
      Date/Time    Abstract Abstract Name
      09.12.2008, 839         The Addition of Rituximab Eliminates the Negative
      08:45                         Prognostic Impact of PMBCL Compared to DLBCL in
                                        Young Patients with CD20-Positive Aggressive
                                        Lymphomas Receiving a CHOP-Like Chemotherapy:
                                        Results of a Subgroup Analysis of the Mabthera
                                        International Trial Group (MInT) Study
      Idiopathic thrombocytic purpura
      Date/Time    Abstract Abstract Name
      07.12.2008, 1            A Prospective Randomized Study Comparing Rituximab
      14:00                         and Dexamethasone Vs Dexamethasone Alone in ITP:
                                        Results of Final Analysis and Long Term Follow up

    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, and is a market leader in virology. It is also active in other major therapeutic areas such as autoimmune diseases, inflammatory and metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 80,000 people. Additional information is available on the Internet at

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