Investor Update
Basel, 12 December 2005
MabThera maintenance therapy dramatically improves survival for patients with lymphoma
Risk of death halved - Roche files label extension in Europe for maintenance therapy
Two years of maintenance therapy with MabThera (rituximab) dramatically improves the chances of survival for patients suffering from one of the most frequent forms of lymphoma, indolent non-Hodgkin’s Lymphoma (NHL). This is the outcome of a clinical trial presented today at the 47th annual meeting of the American Society of Hematology in Atlanta, USA. The trial showed that the risk of death is halved for patients who receive MabThera maintenance therapy, compared to those who receive no maintenance treatment, irrespective of their initial therapy.
Professor Marinus van Oers M.D. from the Academic Medical Center of the University of Amsterdam and lead investigator of the pivotal study said: “Our trial confirms that MabThera maintenance therapy is highly beneficial for all patients, including those who have already received MabThera as part of their initial therapy. We have not seen such an impressive improvement in progression free and overall survival for indolent NHL in the last 30 years. Maintenance therapy with MabThera may well become the new standard of care for these patients.”
Based on this data, Roche will file today with the European authorities for a label extension for MabThera maintenance therapy for patients suffering from indolent lymphoma. In Western Europe alone, 20,000 people are newly diagnosed with indolent NHL every year, and around 40,000 are being treated for this disease.
“We are conscious that these results open a new era in the management of this insidious disease“, said William M. Burns, CEO of the Pharmaceuticals Division at Roche. “NHL is one of the fastest growing cancers and so we are working closely with health authorities to ensure that MabThera is available as maintenance therapy as soon as possible.”
About the study
In the EORTC 20981 (European Organisation for Research and Treatment of Cancer) trial, 465 patients with relapsed and refractory indolent NHL were randomised to receive either 3-weekly cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) chemotherapy or MabThera plus CHOP as induction therapy. Responding patients were then again randomised to either MabThera maintenance, or observation (no further treatment). MabThera maintenance therapy was applied as a single infusion of 375mg/m2 every three months over a period of two years.
The primary endpoints were response rates and progression-free survival for the initial treatment phase and the maintenance phase of the study, respectively. The trial was performed in 130 centres in Canada, Australia, Netherlands, UK, Norway, Slovenia, Slovakia, Belgium, Hungary, South Africa, Sweden, New Zealand, Denmark, Egypt, France, Switzerland, Italy and Poland.
Results of the induction phase
The results of the induction phase of the trial showed that patients who received MabThera and CHOP (R-CHOP) had a significantly higher rate of complete remission than patients who received CHOP chemotherapy alone (29% vs 16%, p value <0.0001). Furthermore, MabThera and CHOP chemotherapy significantly increased progression free survival compared to CHOP chemotherapy alone (median progression-free survival of 33 months vs 20 months, p value 0.0003).
Results of the maintenance phase
| No maintenance | Maintenance | p value | Risk reduction1 | |
|---|---|---|---|---|
| All patients | 77% | 85% | 0.011 | 48% |
| CHOP subgroup | 71% | 82% | 0.073 | 48% |
| R-CHOP subgroup | 81% | 88% | 0.059 | 50% |
| No maintenance | Maintenance | p value | Risk reduction2 | |
|---|---|---|---|---|
| All patients | 15 months | 52 months | <0.0001 | 60% |
| CHOP subgroup | 12 months | 42 months | <0.0001 | 70% |
| R-CHOP subgroup | 23 months | 52 months | 0.0043 | 46% |
1 Treatment effect of maintenance therapy – reduction in the risk of death
2 Treatment effect of maintenance therapy – reduction in the risk of progression of the disease, relapse or death
Conference call
We kindly invite you to participate in Roche's conference call to present and discuss the phase III results on the use of MabThera in indolent Non-Hodgkin’s Lymphoma maintenace therapy on Tuesday 13th December, 2005 from 12:30 to 13:15 CET.
Participants will be:
Dr. Karl Mahler, Head of Investor Relations
Dr. Andreas Abt, Life Cycle Leader MabThera Oncology
Prof. Anton Hagenbeek, Co-Principal Investigator
Analysts and investors are invited to dial in to the conference call using the following dial-in numbers:
+41 (0) 91 610 56 00 (Europe and ROW)
+1 (1) 866 291 41 66 (USA Toll Free)
+44 (0) 207 107 06 11 (UK )
Please dial in to the conference call 10 – 15 minutes before the call is scheduled to start.
Alternatively, a live audio webcast can be accessed via http://ir.roche.com
Ahead of the call, the presentation will be available from the IR website at http://ir.roche.com
A replay of the conference call will be available one hour after the conference call, for 48 hours.
Access is by dialling:
+41 91 612 43 30 (Europe and ROW) or
+1 (1) 866 416 25 58 (USA)
+44 207 108 62 33 (UK )
Listeners will be asked to enter the ID 711 followed by the # sign
About non-hodgkin’s lymphoma
Non-Hodgkin’s lymphoma (NHL) affects 1.5 million people worldwide. Indolent NHL, representing about 45% of NHL patients, is a slow developing but serious cancer of the lymphatic system. It is currently considered incurable. NHL is one of the fastest growing cancers and has grown in incidence by 80% since the early 1970s.i
About MabThera
MabThera is a therapeutic antibody that binds to a particular protein - the CD20 antigen - on the surface of normal and malignant B-cells. It then recruits the body's natural defences to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.
MabThera is indicated for the treatment of indolent and aggressive Non-Hodgkin’s Lymphoma. MabThera is known as Rituxan in the United States, Japan and Canada. More than 730,000 patients have been treated with MabThera worldwide to date.
Genentech and Biogen Idec co-market MabThera in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.
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 a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.
All trademarks used or mentioned in this release are legally protected.
Further Information:
- Genentech
- BiogenIdec
- Roche in Oncology
- Lymphoma
- The Lymphoma Coalition
- Cancer
Note to editors:
i World Health Report 2000, World Health Organization, www.who.int.