Roche Pharmaceuticals

Avastin(R) Demonstrates Impressive Survival Benefit in Lung Cancer Study

    Basel, Switzerland (ots/PRNewswire) -

    - Addition of Avastin Boosts Efficacy of First-Line Chemotherapy for Advanced Non-Small Cell Lung Cancer

    A new study, presented for the first time today, reveals that Avastin(R) (bevacizumab rhuMAb-VEGF) significantly extends survival for patients with previously untreated, advanced non-small cell lung cancer (NSCLC), the most common form of lung cancer.(1) The data were presented at the 2005 American Society of Clinical Oncology (ASCO) Annual Meeting, Orlando, USA.

    The addition of Avastin to platinum-based chemotherapy (paclitaxel and carboplatin) significantly improved overall survival by 30%. The median survival was 12.5 months with Avastin compared to 10.2 months in patients treated with the standard chemotherapy alone. The study also demonstrated a 61% improvement in progression-free survival. The median progression-free survival was 6.4 months with Avastin compared to 4.5 months for those treated with chemotherapy alone. There was also a significant increase in response rates in the Avastin group (27% versus 10%) compared to those receiving chemotherapy alone.(1) This is the first study in years to show an increase in survival for the first-line treatment of patients with advanced NSCLC.

    "The significance of Avastin being able to prolong the life of patients with advanced, non-squamous NSCLC is truly groundbreaking, as we have not seen this with any other targeted therapy in the first-line setting," said Dr Sandler, lead investigator, Vanderbilt University Medical Centre, Nashville, Tennessee, USA. "The addition of Avastin to platinum-based chemotherapy may well become the new standard of care for patients with non-squamous NSCLC."

    Avastin has now shown benefits in three of the most common types of cancer. Lung cancer is the most common cancer worldwide with 1.3 million new cases annually and over 1 million deaths occurring each year.(2) For colorectal cancer there are over one million new cases worldwide and over half a million people dying from the disease each year.(2) In women, breast cancer accounts for one fifth of all cancer cases and each year more than one million new cases are diagnosed worldwide, with a death rate of approximately 410,000 people per year.(2)

    About the Study

    The randomised, controlled, multi-centre study, sponsored by the National Cancer Institute (NCI) and conducted by a network of researchers led by the Eastern Cooperative Oncology Group (ECOG), enrolled 878 patients with advanced NSCLC. Patients were randomised to receive treatment with platinum-based chemotherapy (paclitaxel and carboplatin) with or without Avastin, administered every three weeks for up to six courses. It was reported that the addition of Avastin to chemotherapy was well tolerated.

    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.(3) 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).(4)

    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 the length of time the cancer was not growing, by four months, compared to chemotherapy alone (a 67% increase in progression-free survival).(5)

    A Phase III trial with Avastin in patients with metastatic breast cancer has shown that adding Avastin to first-line paclitaxel chemotherapy resulted in a significant improvement in progression-free survival compared to chemotherapy alone.(6)

    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 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.

    All trademarks used or mentioned in this release are legally protected.

    About Roche: www.roche.com

    About Genentech: www.gene.com

    About cancer: www.health-kiosk.ch

    Roche in Oncology: http://www.roche.com/pages/downloads/company/pdf/mboncology05e.pdf

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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.

    References:

    1. 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.

    2. 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.

    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. 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).

    5. 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.

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

ots Originaltext: Roche Pharmaceuticals
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Emma Robinson, Resolute Communications, +44-207-357-8187



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