Largest-ever studies on most common form of adult leukemia, show patients treated with MabThera live longer without disease progressing

Two Phase III studies to be presented at world’s major hematology meeting prove MabThera’s benefits in treating chronic lymphocytic leukemia (CLL)

Basel, Switzerland – 24 November 2008.  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.
 

Chronic lymphocytic leukemia

Date/Time

Abstract Number

Abstract Name

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)

http://ash.confex.com/ash/2008/webprogram/Paper9237.html

 

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

http://ash.confex.com/ash/2008/webprogram/Paper7815.html

 

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

http://ash.confex.com/ash/2008/webprogram/Paper13658.html

 

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)

http://ash.confex.com/ash/2008/webprogram/Paper5549.html

 

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

http://ash.confex.com/ash/2008/webprogram/Paper15428.html

 

Follicular lymphoma

Date/Time

Abstract Number

Abstract Name

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

http://ash.confex.com/ash/2008/webprogram/Paper6691.html

 

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

http://ash.confex.com/ash/2008/webprogram/Paper9511.html

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

http://ash.confex.com/ash/2008/webprogram/Paper5180.html

 

Diffuse large B-cell lymphoma

Date/Time

Abstract Number

Abstract Name

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

http://ash.confex.com/ash/2008/webprogram/Paper9714.html

Idiopathic thrombocytic purpura

Date/Time

Abstract Number

Abstract Name

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

http://ash.confex.com/ash/2008/webprogram/Paper8341.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.

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

For more information, please contact:
Peter Bayliss
International Communications Manager
+ 41 79 572 51 93
peter.bayliss@roche.com.au

Posted: November 2008

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