Roche Pharmaceuticals

New Avastin(R) Study Shows Dramatic Survival Benefits for Patients With Metastatic Breast Cancer

    Basel, Switzerland (ots/PRNewswire) -

    - Anti-Angiogenic Treatment Shows Survival Benefit Across Three Major Cancer Types: Breast, Lung And Colorectal Cancer

    A new study with Avastin(R) (bevacizumab, rhuMAb-VEGF) today reported that when used in combination with chemotherapy, Avastin doubled the chances of surviving without cancer progression in patients with previously untreated, metastatic breast cancer, compared to chemotherapy alone.(1) The data were presented at the 2005 American Society of Clinical Oncology (ASCO) annual meeting, Orlando, USA. There are now three cancer types in which Avastin has demonstrated significant clinical benefit. Multiple studies have shown prolonged overall survival in advanced colorectal cancer, for which Avastin is indicated, and a new study, also reported today at ASCO, shows longer overall survival in metastatic non-small cell lung cancer.(2) Avastin is the only anti-angiogenic agent to report a survival benefit in any of these cancer types.

    Avastin is the groundbreaking anti-angiogenesis drug that works by choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body. The latest phase III study demonstrated that patients treated with Avastin and a standard chemotherapy, paclitaxel, had a significant increase in median progression-free survival (the amount of time patients lived without their cancer getting worse) to, on average, 11 months, compared to six months for patients treated with standard chemotherapy alone. Results from this interim analysis showed a 49% improvement in overall survival and the overall response rate was 28% in the Avastin group compared to 14% in those treated with chemotherapy alone.

    "This is the very first time we have seen the benefits of an anti-angiogenic therapy in breast cancer," said Professor Kathy Miller, lead investigator, Indiana University Cancer Centre, Indianapolis, USA. "The fact that Avastin has now demonstrated significant clinical benefits in three of the most common types of cancer, colorectal, lung and breast cancer, highlights how this anti-angiogenesis drug has the potential to completely change the way we treat cancer, as it could become the mainstay of treatment for a whole range of cancers."

    In women, breast cancer accounts for one fifth of all cancer cases and each year and more than one million new cases are diagnosed worldwide, with a death rate of approximately 410,000 people per year.(3) For colorectal cancer there are over one million new cases worldwide and over half a million people dying from the disease each year.(3) Lastly, lung cancer is the most common cancer worldwide with 1.3 million new cases annually and over 1 million deaths occurring each year.(3)

    About the study

    The randomised, controlled, multicentre Phase III study was the first to evaluate Avastin in combination with chemotherapy for the treatment of patients with previously untreated, metastatic breast cancer (first-line). The study was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG). In total, 722 patients were randomised to receive treatment with paclitaxel with or without Avastin. Patients with HER2-positive metastatic breast cancer were not enrolled in the study unless they had received prior treatment with Herceptin (trastuzumab) or were unable to receive treatment with Herceptin. Patients who had received adjuvant paclitaxel within the previous 12 months and patients with a prior history of blood clots or who were receiving blood thinners were also excluded from the study.

    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).

    In Europe, Avastin is approved for 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. Avastin received fast-track approval by the US Food and Drug Administration (FDA) and was launched in the US in February 2004. (i)

    In the pivotal Phase III study, the addition of Avastin to chemotherapy (irinotecan/5-fluorouracil/leucovorin) significantly extended survival by, on average, five months (20.3 months versus 15.6 months) for people with previously untreated metastatic colorectal cancer.(4) In a Phase III study with patients who had previously failed one chemotherapy regimen for their advanced disease, Avastin was also shown to significantly improve survival, by an average of approximately two months (12.5 months versus 10.7 months), when added to a widely prescribed oxaliplatin-containing chemotherapy regimen (oxaliplatin/5-fluorouracil/leucovorin).(5)

    People with very advanced colorectal cancer who are too unwell to tolerate traditional aggressive chemotherapy also benefit from Avastin. The addition of Avastin to a less aggressive form of chemotherapy increased progression-free survival by four months, compared to chemotherapy alone (a 67 per cent increase).(6)

    A Phase III trial with Avastin in patients with previously untreated advanced non-small cell lung cancer has shown that adding Avastin to first-line platinum-based chemotherapy (paclitaxel and carboplatin) significantly increased overall survival from 10.2 months to 12.5 months.(2)

    Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in advanced colorectal cancer with other chemotherapies and also expanding into the adjuvant setting (post operation). As its mechanism may be relevant in a number of malignant tumours, Roche and Genentech are also investigating the potential clinical benefit of Avastin in pancreatic cancer, ovarian cancer, renal cell carcinoma and others. Approximately 15,000 patients are expected to be enrolled into clinical trials over the next few years worldwide.

    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.

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    Note for editors

    (i) In the US, Avastin is approved for use in combination with intravenous 5-fluorouracil-based chemotherapy, for first-line treatment of patients with metastatic carcinoma of the colon or rectum.


    1. Kathy D Miller et al. ECOG E2100 study. Presented at 2005 ASCO Annual Meeting.

    2. Sandler AB, Gray R, Bhramer J, et al. Randomized phase II/III Trial of paclitaxel (P) plus carboplatin (C) with or without bevacizumab (NSC # 704865) in patients with advanced non-squamous non-small cell lung cancer (NSCLC): An Eastern Cooperative Oncology Group (ECOG) Trial - E4599. ASCO 2005, Abstract LBA4.

    3. J. Ferlay, F. Bray, P. Pisani and D.M. Parkin. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide IARC CancerBase No. 5. version 2.0, IARCPress, Lyon, 2004.

    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.

    5. Mitchell EP, Alberts SR, Schwartz BJ, et al. High-dose bevacizumab in combination with FOLFOX4 improves survival in patients with previously treated advanced colorectal cancer: Results from the Eastern Cooperative Oncology Group (ECOG) study E3200. ASCO Gastrointestinal 2005 Cancer Symposium, January 2005 (abstract 169a).

    6. 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

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