Roche Pharmaceuticals

Avastin(R) Extends Survival in Patients With Advanced Colorectal Cancer; New Data Supports Its Combination With Widely Prescribed Chemotherapy

Basel, Switzerland (ots/PRNewswire) - - Study adds to the body of evidence showing the benefits of Avastin with different colorectal cancer treatment regimens A new study, presented for the first time today, shows Avastin(R) (bevacizumab, rhuMAb-VEGF) significantly increases survival in patients with advanced colorectal cancer when used in combination with an oxaliplatin-containing chemotherapy regimen. This is the first phase III study to evaluate the use of Avastin with oxaliplatin and it is of particular significance as oxaliplatin-containing chemotherapy regimens are widely used in first- and second-line metastatic colorectal cancer therapy. The data were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium, Florida, USA.(1) Combining Avastin, an innovative new anti-angiogenesis drug, with an oxaliplatin-containing chemotherapy regimen (FOLFOX4) resulted in a significant increase in overall survival, from 10.7 months to 12.5 months, in patients with advanced colorectal cancer who had previously failed one chemotherapy regimen for their advanced disease. Data also showed that patients receiving Avastin plus chemotherapy had a 26 per cent reduction in the risk of death compared to those treated with chemotherapy alone.(1) The study (E3200) was sponsored by the National Cancer Institute and conducted by researchers led by the Eastern Cooperative Oncology Group (ECOG). "These compelling results support the hypothesis that Avastin can prolong survival of colorectal cancer patients, independent of the type of chemotherapy that is administered. This is the third chemotherapy regimen where the addition of Avastin has shown a major benefit," commented Dr Bruce J. Giantonio, lead study investigator, Abramson Cancer Center, University of Pennsylvania. These results add to the growing body of evidence showing the benefit patients with advanced colorectal cancer receive when they are treated with Avastin. In a landmark study published in 2004 in the New England Journal of Medicine, Avastin showed a significant survival benefit when used in combination with chemotherapy in patients who had not received previous chemotherapy for their advanced colorectal cancer. In addition, another study showed Avastin plus chemotherapy in patients with advanced colorectal cancer showed a significant increase in progression-free survival. This study used a milder form of chemotherapy than the pivotal study, as this patient group were unfit to receive more toxic chemotherapeutic regimens. A preliminary analysis of a second study with Avastin known as the TREE 2 trial was also presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium. The study evaluated Avastin use in combination with three different oxaliplatin-containing chemotherapy regimens in patients with previously untreated advanced colorectal cancer. The study showed that the addition of Avastin was well tolerated and significantly improved overall response rates when added to each of the oxaliplatin-containing chemotherapy regimens. (2) Colorectal cancer is the third most commonly reported cancer with 945,000 new cases worldwide each year. (3) 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. About the E3200 Study Results from a preliminary analysis demonstrated that patients receiving Avastin plus FOLFOX4 had a 26 percent reduction in the risk of death, a hazard ratio of 0.74, compared to patients who received FOLFOX4 alone. Median survival for patients receiving Avastin plus FOLFOX4 was 12.5 months, compared to 10.7 months for those receiving FOLFOX4 alone, a 17 percent improvement. 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). Results from the pivotal Phase III study published in thepublished New England Journal of Medicine in 2004, 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.(4) 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 research sites (two in the United States and one each in Germany and Japan) and five 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-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative 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 is a world leader in Diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs in prescription drug sales, while the Diagnostics Division posted sales of 7.4 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: - www.roche.com - www.gene.com - www.health-kiosk.ch - www.thenewsmarket.com References: 1. 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 2005 Cancer Symposium (abstract 241). 2. Hochster H et al. Bevacizumab with oxaliplatin-based chemotherapy in the first-line therapy of metastatic colorectal cancer (mCRC): Preliminary results of the 'TREE-2' trial. ASCO Gastrointestinal 2005 Cancer Symposium (abstract 10148). 3. 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 4. 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 ots Originaltext: Roche Pharmaceuticals Im Internet recherchierbar: http://www.newsaktuell.ch Contact: For further information, please contact: Emma Robinson, Resolute Communications, Ground Floor, The Blue Building, London, SE1 3LA, +44-(0)-20-7357-8187, Emma.Robinson@resolutecommunications.com

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