Basel, 2 June 2003

Increased potential for cure for people with aggressive blood cancer
Three-year follow up data from GELA study shows greatly improved long term survival for aggressive non-Hodgkin’s lymphoma patients treated with MabThera

Data presented today at the American Society of Clinical Oncology (ASCO) annual meeting showed that patients with an aggressive form of the blood cancer, non-Hodgkin’s lymphoma (NHL), who were treated with MabThera plus standard chemotherapy (CHOP), have an improved chance of survival after three years compared with those treated with standard chemotherapy alone. These results offer significant hope for people with the aggressive form of NHL, one of the most common types of blood cancer of the lymphatic system. Current medical opinion indicates that if patients survive past the two-year landmark their chance of a cure can be up to 90%1.

Results from the pivotal GELA Study (Groupe d’Etude des Lymphomes de l’Adulte) have shown that three-year event free survival for patients treated with MabThera plus CHOP is 53%, compared to 35% for patients treated with CHOP alone2. Moreover, 62% of those patients receiving MabThera plus CHOP were still alive 3 years after treatment compared to 51% of the patients who were treated with chemotherapy alone. Importantly, MabThera did not increase the toxicity of therapy when compared to chemotherapy alone2.

“These results represent a real breakthrough for people with aggressive NHL. This combination therapy is the first treatment in 20 years to offer patients a great improvement in long term survival,” commented principal GELA study investigator Professor Bertrand Coiffier, head of the Department of Hematology, Hospices Civiles de Lyon, France. “It confirms that MabThera plus CHOP is the gold standard treatment for this aggressive form of cancer. It is the only recent treatment in aggressive NHL proven to increase survival and potentially offer a cure without an increase in toxicity. People with aggressive NHL must be treated with this combination wherever possible.”

MabThera works by ‘seek and destroy’ action, which unlike chemotherapy specifically targets tumour cells, therefore it does not cause the unpleasant side effects associated with traditional chemotherapy. Approximately 1.5 million people worldwide have NHL, 55% of them have the aggressive form of the disease, which if left untreated can be fatal within six months. The remaining 45% suffer from indolent NHL, where tumour cells divide slowly and patients may live for many years, however currently there is no cure. The causes of NHL remain unknown, however it is more common than leukaemia and worldwide is the 3rd fastest growing form of cancer, after skin melanoma and lung cancer3.

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 the Roche World-Wide Prescription Group’s largest prescription product just four years after its first launch.

Roche in Oncology
Roche is a world leader in oncology. Its franchise includes Herceptin (breast cancer), MabThera (non-Hodgkin's lymphoma), Xeloda (colorectal cancer, breast cancer) NeoRecormon (anaemia in various cancer settings), Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma) and Kytril (chemotherapy and radiotherapy-induced nausea). Roche Oncology has four research sites (two in the US, Germany and Japan) and four HQ Development sites (two in the US, UK and Switzerland) dedicated to Oncology.
Roche also offers a broad portfolio of tumor markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests running on the LightCycler. Within its Integrated Cancer Care Unit the company develops new tests which will have a significant impact on disease management of cancer patients in the future.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market and is the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the 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 employs roughly 62,000 people in 150 countries. The Group has alliances and research and development agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

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References:
1. Fisher et al, New Eng. Jrnl Med., April 1993, 328:1002-6
2. Abstract #2395: GELA study comparing CHOP and R-CHOP in Elderly Patients with Diffuse Large B-Cell Lymphoma: 3 year median follow-up with an analysis according to co-morbidity factors. 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 study analysed 399 previously untreated elderly patients (60 to 80 years old) with aggressive non-Hodgkin’s lymphoma. Patients were randomised to receive standard CHOP chemotherapy or MabThera plus CHOP.
3. World Health Report 2000: World Health Organisation (www.who.int)

For B-roll footage (including an interview with principal GELA study investigator, Professor Bertrand Coiffier) please go to the website and enter ‘MabThera’ in the search function.