More chance of a cure for patients with common and aggressive form of blood cancer

December 10, 2001

Two year follow up from pivotal study shows benefit of using MabThera® plus CHOP chemotherapy in the treatment of aggressive non-Hodgkin's lymphoma (NHL)

Orlando, Florida, 10 December 2001 - Patients with an aggressive form of blood cancer, non-Hodgkin's lymphoma, can increase their chance of a cure with the new drug combination MabThera (rituximab) plus CHOP (standard chemotherapy), compared to standard chemotherapy alone. This is according to two year results from the pivotal GELA study presented today at the American Society of Hematology (ASH).

Based on these updated results it is estimated that after a median follow up of almost 26 months, 70% of patients treated with the MabThera plus CHOP combination will be alive and well, compared to 57% after standard chemotherapy alone. Current medical opinion indicates that if patients survive past the two-year milestone their chances of a cure can be up to 90% .

Lead investigator for the GELA study, Professor Bertrand Coiffier, head of the Department of Hematology, Hospices Civiles de Lyon, France said: "This is the first new drug combination in more than 20 years to show an improvement in overall survival for patients with aggressive non-Hodgkin's lymphoma (NHL), a rapidly fatal form of the cancer. This is a real breakthrough for NHL sufferers around the world."

The MabThera plus CHOP combination is also effective in treating another form of the disease known as indolent, or low grade NHL. Dr Myron Czuczman's data on the six year follow-up of patients with indolent NHL, treated with MabThera plus CHOP showed that 55% of the patients are still in remission at almost four years (46.8 months) and up to seven years (86.3 months). All patients treated responded (58% complete response and 42% partial response) and the overall response rate in patients who completed therapy was 100% (63% complete response and 37% partial response).

Approximately 1.5 million people worldwide have NHL, 55% of them have the aggressive form of the disease, the remaining 45% suffer from indolent, or low grade NHL. NHL is more common than leukaemia and world-wide is the 3rd fastest growing form of cancer, after skin melanoma and lung cancer.

MabThera was discovered by IDEC Pharmaceuticals Corporation and was jointly developed by IDEC, Genentech, Inc, Roche and Zenyaku Kogyo Co. Ltd of Japan. In July 1998, Genentech granted Roche exclusive marketing rights for MabThera outside the USA. (marketed as Rituxan® in USA, Japan and Canada). MabThera is Roche's second largest prescription product just four years after its first launch.

Roche is a world leader in Oncology. Its Franchise includes MabThera (non-Hodgkin's lymphoma), Xeloda (colorectal cancer, breast cancer), Herceptin (breast cancer), NeoRecormon (anaemia in various cancer settings), Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma), Neupogen (neutropenia) and Kytril (chemotherapy and radiotherapy-induced nausea).

In the first nine months of 2001 the Roche oncology portfolio reached over 2 billion Swiss Francs in sales. With these innovative anti-cancer products and promising new drugs coming through the pipeline Roche expects to see strong growth in its Oncology Franchise in the future.
-end-
Please visit www.roche.com for further information.

For further information:
Rina Amin

Ketchum
London
Tel: +44 20 7611 3513
E-mail: rina.amin@ketchum.com

Carrie Deverell
Roche International
Tel: +41 61 688 98 48
E-mail: carrie.deverell@roche.com

1 Abstract #3025: Rituximab plus CHOP (R-CHOP) in the Treatment of Elderly Patients with Diffuse Large B-Cell Lymphoma. An Update of the GELA study. This phase III study was conducted by Groupe d'Etude des Lymphomes de l'Adulte (GELA), a large cancer co-operative group of more than 110 institutions in France, Belgium and Switzerland. The interim analysis analysed 328 out of the enrolled 399 previously untreated elderly patients (60 years or older) with aggressive NHL. Patients 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.

Ketchum UK

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