Significant survival benefit shown with MabThera and chop chemotherapy in aggressive non-Hodgkin's lymphoma

December 02, 2000

-- First new drug combination in 20 years to improve overall survival --

SAN FRANCISCO - Dec. 3, 2000 - Roche today announced positive interim results from a Phase III study evaluating the combination use of MabThera (rituximab) and CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) chemotherapy in previously-untreated patients with aggressive non-Hodgkin's lymphoma (NHL). MabThera is marketed as Rituxan in the United States by Genentech and IDEC Pharmaceuticals.

Results from an interim analysis of 328 patients showed that those treated with the rituximab combination therapy (R-CHOP) experienced a significant improvement versus the CHOP alone arm, showing:

· Survival at 1- year: 83 percent (R-CHOP) versus 68 percent (CHOP);
· Disease-free at 1-year: 69 percent (R-CHOP) versus 49 percent (CHOP);
· Complete remission: 76 percent (R-CHOP) vs. 60 percent (CHOP). Patients who experience a complete remission have a higher chance to be cured.

The study, conducted by the Groupe d'Etude des Lymphomes de l'Adulte (GELA), a large cancer co-operative group of more than 130 institutions in France, Belgium and Switzerland, was presented at the plenary session of the 42nd annual meeting of the American Society of Hematology.

"This is the first new drug combination in 20 years to show an improvement in overall survival in aggressive NHL," said Professor Bertrand Coiffier, head of the Department of Hematology, Hospices Civiles de Lyon, France, and principal investigator of the study. "These results are compelling because standard chemotherapy has shown only a 30 to 40 percent cure rate in a disease that can be rapidly fatal."

Approximately 4.5 million people around the world are living with various forms of lymphoma and it is estimated that 300,000 people die each year. In terms of incidence and death, NHL is the second fastest growing cancer in the United States and the third fastest growing in the rest of the world. In Europe, the highest prevalence is in Italy and Germany with nearly 23,500 new NHL cases expected in 2000.3

In the Phase III study, 400 previously-untreated elderly patients (60 years or older) with aggressive NHL were randomised to receive standard CHOP chemotherapy alone (every three weeks for eight cycles) or MabThera (375 mg/m2) plus CHOP. MabThera was administered at the same time as CHOP for eight cycles.

Adding MabThera to CHOP chemotherapy did not appear to cause a clinically significant increase in adverse events to those seen with CHOP chemotherapy alone. A total of 77 events (48 percent) were observed in the CHOP arm and 49 events (29 percent) were observed in the combination arm. Approximately 10 percent of patients experienced a Grade 3/4 infusion-related event during the first infusion of MabThera.

Roche, headquartered in Basel, Switzerland, is one of the world's leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche's innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people's well-being and quality of life. Roche has approximately 63,900 employees and sells its products in over 170 countries. The Roche Group posted sales of 20.3 billion Swiss francs in the first nine months of 2000. In the first half of 2000 the company's net income amounted to 3 billion Swiss francs. It invested 1.9 billion Swiss francs in research and development.
Media Contact: Dr. Urs Schleuniger

Notes to Editors

1. Lymphomas generally are classified into two equal groups: one half are indolent (low grade) lymphomas while the remaining are aggressive (intermediate/high grade). Intermediate/high grade lymphomas spread rapidly, and left untreated, can be fatal within six months to two years.
2. Patients who are diagnosed and treated in early stages of aggressive disease are more likely to experience a complete remission of several years in duration and are less likely to have late recurrences. In contrast, while low-grade lymphomas progress slowly and patients may live an average of six to seven years, standard treatments cannot cure the disease.
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2 World Health Report 2000, World Health Organization,
3. Data on file, F. Hoffmann-La Roche Ltd, Basel, Switzerland. (Cancer Opportunities in the New Millennium, Confidential Draft Report, SRI Consulting, 2000)

Ketchum UK

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