Investor Update
Basel, 21 November 2008
Study of MabThera in the most common form of adult leukaemia selected as late-breaking abstract for the ASH annual meeting
Second phase III trial using MabThera in patients with Chronic Lymphocytic Leukaemia (CLL) shows it can help patients live longer without their disease getting worse
Roche announced today that full results of the pivotal REACH study will be presented as part of the late breaker abstract session at the annual meeting of the American Society of Hematology (ASH). As previously announced, the randomized phase III study in patients with relapsed or refractory CLL successfully met its primary endpoint by showing that MabThera in combination with the current standard chemotherapy regimen significantly extended the amount of time patients lived without their disease progressing (progression-free survival, PFS), compared to patients treated with the standard chemotherapy regimen alone.
In addition, results from another pivotal phase III study of MabThera in first-line treatment of CLL (the CLL8 study) will be presented at the ASH meeting. The CLL8 study successfully met its primary endpoint by showing that patients treated with MabThera in combination with the current standard chemotherapy regimen achieved a significant improvement in progression-free survival, compared to patients treated with the standard chemotherapy regimen alone.
Roche submitted a Marketing Authorisation Application (MAA) for MabThera in first-line treatment of CLL to the European Medicines Agency (EMEA) earlier this year based on results of an interim analysis of the CLL8 study.
The presentation of the REACH and CLL8 study results is complemented by more than 270 other MabThera-related abstracts that have been accepted covering important trials across a range of areas including chronic lymphocytic leukaemia, follicular lymphoma, diffuse large B-cell lymphoma and immune thrombocytic and idiopathic thrombocytic purpura. The wealth of data in both new settings such as CLL and in long-term use of MabThera in approved indications such as follicular lymphoma and diffuse large B-cell lymphoma underlines the importance of this product in the fight against cancer. MabThera has already been used to treat over 1.5 million patients in its existing hematologic indications.
In addition, Roche will present the first very promising phase I clinical data on R7159/GA101, a fully humanized and glyco-engineered 3rd generation anti-CD20 monoclonal antibody. R7159/GA101 was developed by Glycart and Roche and licensed to Genentech for the treatment of CD20-positive hematological malignancies, including CLL and NHL.
Roche investor science event
Roche will host an investor science conference call on Tuesday, 9 December 2008 to discuss the new clinical data and results presented during the 2008 ASH annual meeting.
During 2008, Roche has conducted regular science events for investors and analysts at most major scientific meetings on both Pharma and Diagnostics, including ACC, ASCO, ADA, EULAR and AACC. The ASH conference call concludes the planned 2008 activities, but we look forward to welcoming investors and analysts to more events in 2009.
Key Roche abstracts
| Date/Time | Abstract Number | Abstract Name | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 08.12.2008, 11:00 | 325 | Immunochemotherapy with Fludarabine (F), 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, 07:30 | 15742 | Rituximab, Fludarabine, and Cyclophosphamide (R-FC) 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, 08:00 | 781 | Genomic Aberrations, VH Mutation Status and Outcome after Fludarabine and Cyclophosphamide (FC) or FC Plus Rituximab (FCR) in the CLL8 Trial | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 08.12.2008, 11:15 | 326 | Quantitative MRD Assessments Predict Progression 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, 12:15 | 330 | Bendamustine in Combination with Rituximab (BR) for Patients with Relapsed Chronic Lymphocytic Leukemia (CLL): A Multicentre Phase II Trial of the German CLL Study Group (GCLLSG) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 07.12.2008, 17:30 | 47 | Rituximab and High-Dose Methylprednisolone for the Initial Treatment of Chronic Lymphocytic Leukemia is Associated with Promising Clinical Activity and Minimal Hematologic Toxicity | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Follicular lymphoma | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 09.12.2008, 08:00 | 836 | Rituximab Maintenance Treatment of Relapsed/Resistant Follicular Non-Hodgkin’s Lymphoma: Long-Term Outcome of the EORTC 20981 Phase III Randomized Intergroup Study | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 07.12.2008 (poster Board II-693) | 2599 | Rituximab in Combination with CHOP in Patients with Follicular Lymphoma: Analysis of Treatment Outcome of 552 Patients Treated in a Randomized Trial of the German Low Grade Lymphoma Study Group (GLSG) after a Follow up of 58 Months | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 09.12.2008, 08:00 | 773 | Autologous Stem Cell Transplantation (auto-SCT) as 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 09.12.2008, 08:45 | 839 | The Addition of Rituximab Eliminates the Negative 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 07.12.2008, 14:00 | 1 | A Prospective Randomized Study Comparing Rituximab and Dexamethasone vs Dexamethasone alone in ITP: Results of Final Analysis and Long Term Follow up | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| R7159/GA101 - CD20+ malignant disease | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 08.12.2008, 08:15 | 234 | A Phase I/II Study of RO5072759 (GA101) in Patients with Relapsed/Refractory CD20+ Malignant Disease http://ash.confex.com/ash/2008/webprogram/Paper8190.html | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 www.roche.com.
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