Roche Pharmaceuticals

Avastin Proven Effective Even in Advanced Colorectal Cancer Patients Who Are Unable to Tolerate Aggressive Chemotherapy

Basel, Switzerland (ots/PRNewswire) - - New Study Published Today Provides Further Evidence of the Benefit of Avastin(R) for Patients With Advanced Colorectal Cancer Data published for the first time today in the leading Journal of Clinical Oncology showed that the unique new cancer drug Avastin keeps cancer under control for a significantly longer duration, even when used in a group of elderly patients with advanced* colorectal cancer who are too sick to tolerate traditional aggressive chemotherapy. Avastin (bevacizumab, rhuMAb-VEGF), when added to a less aggressive form of chemotherapy, prolonged the time the cancer was not growing by an extra four months compared to chemotherapy alone (a 67% increase in progression-free survival).(1) "The additional four months of median survival that Avastin offers is of significant clinical benefit for these patients, who are unable to be treated with other more aggressive traditional chemotherapy combinations," said Dr Fairooz Kabbinavar, lead study investigator and Associate Professor at the UCLA School of Medicine, Los Angeles, USA. "In my opinion, these data indicate that Avastin should be a part of standard therapy for this group of frail and elderly patients, who currently have limited chemotherapy treatment options." "This is an important study as it is the third clinical trial in which Avastin has shown a major benefit when combined with chemotherapy to treat advanced colorectal cancer. The growing body of evidence shows that Avastin not only provides valuable clinical benefit in first- and second-line settings and with different chemotherapy regimens, but is also well tolerated by a wide group of patients receiving treatment for their advanced disease," said Stefan Manth, Head of Roche Oncology. Colorectal cancer is the third most commonly reported cancer with 945,000 new cases worldwide each year. It is estimated that over 50% of people diagnosed with colorectal cancer will die of the disease.(2) Study Details A total of 209 patients, over 65 years old and/or too unfit to receive a more aggressive chemotherapy, irinotecan, were randomised to receive a chemotherapy combination they could better tolerate (5-fluorouracil and leucovorin) with or without Avastin, in the first-line setting. The Phase II study showed that progression-free survival was significantly increased in the Avastin group (9.2 months vs. 5.5 months) compared to those treated with chemotherapy alone. Overall survival showed an improvement in the Avastin group (median, 16.6 months vs. 12.9 months) as did the response rates (26.0% vs. 15.2%) and the duration of response (9.2 months vs. 6.8 months). Results from the pivotal Phase III study published in the New England Journal of Medicine demonstrated significantly longer survival in patients with previously untreated advanced colorectal cancer. The study, in which more than 900 patients participated, showed that Avastin plus chemotherapy increased overall survival by nearly five months (20.3 months vs. 15.6 months) compared to chemotherapy alone.(3) The Phase III trial conducted by Eastern Cooperative Oncology Group (ECOG) also showed a significant increase in survival in patients with advanced colorectal cancer (12.5 months vs. 10.7 months) when Avastin was used in combination with a standard oxaliplatin-containing chemotherapy regimen, compared to chemotherapy alone. Patients receiving Avastin plus chemotherapy had a 26 percent reduction in the risk of death (hazard ratio of 0.74).(4) About Avastin Avastin is the first treatment that inhibits angiogenesis - the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis). Avastin received fast-track approval by the US Food and Drug Administration (FDA) and was launched in the US in February 2004. In January 2005, the European Commission approved Avastin for the first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with the chemotherapy regimens of intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan. Roche in Oncology Within the last five years the Roche Group, including its members Genentech in the United States and Chugai in Japan, has become the world's leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented five products with survival benefit in different major tumour indications: Xeloda and Herceptin in advanced stage breast cancer, MabThera in non-Hodgkin's lymphoma, Avastin in colorectal carcinoma and Tarceva in non-small cell lung cancer and pancreatic carcinoma. In the United States Herceptin, MabThera, Avastin and Tarceva are marketed either by Genentech alone or together with its partners Biogen Idec Inc. (MabThera) and OSI (Tarceva). Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these medicines. The Roche oncology portfolio also includes NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcaemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA is the most recent demonstration of Roche's commitment to anaemia management. The Roche Group's cancer medicines generated sales of more than 5.6 billion Swiss francs in the first nine months of 2004. In addition to the medicines, Roche is developing new diagnostic tests that will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, Roche will continue to be the leader in providing cancer-focused treatments and diagnostics. Roche has four oncology research sites (two in the United States and one each in Germany and Japan) and five oncology development sites (two in the United States and one each in UK, Australia and Switzerland). 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: About Roche: www.roche.com About Genentech: www.gene.com About cancer: www.health-kiosk.ch To preview and request free B-roll/video content about Avastin, log onto www.thenewsmarket.com. You can receive broadcast-standard video digitally, by tape or satellite via the APTN Global Video Wire from this site. Registration and video on the site is free to the media. * Cancer that has spread (metastasised) to other parts of the body. References: (1) Kabbinavar FF, Joseph Schulz J, McCleod M, et al. Addition of Bevacizumab to Bolus 5-FU/Leucovorin in First-Line Metastatic Colorectal Cancer: Results of a Randomized Phase II Trial.) J Clin Oncol 23:10.1200/JCO.2005.05.112, 2005 (2) J. Ferlay, F. Bray, P. Pisani and D.M. Parkin. GLOBOCAN 2000: Cancer Incidence, Mortality and Prevalence Worldwide, Version 1.0. IARC CancerBase No. 5. Lyon, IARCPress, 2001 (3) Hurwitz, H, Fehrenbacher, L, Novotny, W, et al. Bevacizumab plus Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal Cancer. New England Journal of Medicine 2004; 350(23): 2335-2342 (4) Giantonio BJ et al. The addition of bevacizumab (anti-VEGF) to FOLFOX4 in previously treated advanced colorectal cancer (advCRC): An updated interim toxicity analysis of the Eastern Cooperative Oncology Group (ECOG) study E3200. ASCO Gastrointestinal 2004 Cancer Symposium (abstract #241). ots Originaltext: Roche Pharmaceuticals Im Internet recherchierbar: http://www.presseportal.ch Contact: Emma Robinson or Nina Jones at Resolute Communications, Tel: +44-(0)-20-7357-8187, emma.robinson@resolutecommunications.com

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