Investor Update
Basel, 2 June 2006
MabThera Receives Positive Opinion In Europe For Maintenance Therapy In Relapsed or Refractory Follicular Non-Hodgkin’s Lymphoma
New treatment option dramatically improves patient survival
Roche announced today that the European Union’s Committee on Human Medical Products (CHMP) has given a positive recommendation for the use of MabThera as maintenance therapy for patients with relapsed or refractory follicular Non-Hodgkin’s Lymphoma (NHL). Patients will now have access to MabThera maintenance therapy that has been clinically proven to reduce the risk of death by almost half (48%) compared to standard disease management.
“We have not seen such a remarkable improvement in survival for indolent NHL in the last 30 years. The trial demonstrated that MabThera maintenance therapy is well tolerated and highly beneficial for all patients, including those who have already received MabThera as part of their initial therapy,” said Professor Marinus van Oers M.D. from the Academic Medical Center of the University of Amsterdam and lead investigator of the pivotal study. “Maintenance therapy with MabThera may well become the new standard of care for these patients.”
"The positive opinion is an important step forward leading towards the availability of MabThera maintenance therapy for all patients who could benefit from it," said Ed Holdener, Head of Roche’s Global Pharma Development. "The dramatic benefit observed with MabThera maintenance therapy as demonstrated by the prolongation of progression-free survival and overall survival provides hope and confidence for the future in this difficult to cure disease."
The label extension is based on the impressive results of the EORTC (European Organisation for Research and Treatment of Cancer) 20981 study, performed in 18 countries worldwide, that was presented at the 47th annual conference of the American Society of Hematology in Atlanta in December 2005.
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. NHL is one of the fastest growing cancers and has grown in incidence by 80% since the early 1970s.
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About the pivotal study
In the EORTC 20981 (European Organisation for Research and Treatment of Cancer) trial, 465 patients with relapsed or refractory follicular 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 therapy, or observation (no further treatment).
MabThera maintenance therapy was applied as a single infusion of 375 mg/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 reductiona | |
|---|---|---|---|---|
| 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 reductionb | |
|---|---|---|---|---|
| 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% |
a Treatment effect of maintenance therapy – reduction in the risk of death
b Treatment effect of maintenance therapy – reduction in the risk of progression of the disease, relapse or death
About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma (NHL) affects 1 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.
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. More than 730,000 patients have been treated with MabThera worldwide to date.
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 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).
All trademarks used or mentioned in this release are legally protected.
Further Information
- Roche in Oncology
- Lymphoma
- The Lymphoma Coalition
- Cancer
- World Health Organization
References:
1 World Health Report 2000, World Health Organization, www.who.int.