Roche Pharmaceuticals

Landmark Study of Avastin in Lung Cancer Published Today in New England Journal of Medicine

    Basel, Switzerland (ots/PRNewswire) -

    - Avastin is First Medicine to Extend Survival Beyond One Year in Patients With Previously Untreated Non-Small Cell Lung Cancer

    Avastin is the first medicine proven to help previously untreated patients suffering from the most common form of lung cancer to live longer than a year, according to a landmark US study (E4599) published today in the prestigious New England Journal of Medicine.

    The study showed that the median duration of survival in the Avastin plus paclitaxel and carboplatin chemotherapy group was 12.3 months compared to 10.3 months in the group treated with chemotherapy alone. Overall patients treated with Avastin plus chemotherapy had an approximate 27 percent improvement in survival compared to patients receiving chemotherapy alone.

    "This is the first large, randomized clinical study in which an anti-angiogenic, combined with chemotherapy, extended survival beyond one year in patients with advanced lung cancer," said Alan B. Sandler, M.D., director of Medical Thoracic Oncology at Vanderbilt-Ingram Cancer Center in Nashville, Tenn., and Study Chair for the E4599 trial. "The results of this study have changed the treatment standard of care for this devastating disease - an important step forward for patients with advanced lung cancer."

    The results from the pivotal study highlight the outstanding achievements of the innovative cancer medicine Avastin in helping people with previously untreated advanced NSCLC[i]. Lung cancer is the most common form of cancer as well as the single biggest cancer killer with more than 900 lives lost to the disease every day in Europe and new treatment options are desperately needed.

    The impressive data from the E4599 study formed the basis for the US approval of Avastin for treatment of advanced NSCLC which was granted by the FDA in October 2006. For the European filing[ii] which was submitted on 8 August 2006, the E4599 study was supported by the preliminary data from the ongoing "Avastin in Lung" (BO17704) study.

    Avastin was approved in the EU in January 2005 and in the US in February 2004 for the first-line treatment of patients with metastatic colorectal cancer. It received another approval in the US in June 2006 as a second-line treatment for patients with metastatic colorectal cancer. The first filing for Avastin in Japan occurred in April 2006 for the treatment of metastatic colorectal cancer. More recently, Avastin was filed for the treatment of women with advanced breast cancer in the EU in July 2006.

    About the pivotal E4599 study

    The results of the randomised, controlled, multicenter Phase III E4599 study of 878 patients with locally advanced, metastatic or recurrent NSCLC, with histology other than predominant squamous cell, show that:

    - Median survival of patients treated with Avastin at a dose of 15 mg/kg every three weeks plus chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone

    - Patients receiving Avastin at a dose of 15 mg/kg every three weeks plus paclitaxel and carboplatin had an approximate 27 percent improvement in overall survival, compared to patients who received chemotherapy alone

    - Median duration of progression-free survival (measure of the time patients live without their disease progressing) was 6.2 months for patients treated with Avastin plus chemotherapy, compared to 4.5 months for patients treated with chemotherapy alone

    - Response rate in patients with measurable disease was more than doubled to 35 percent in the group receiving Avastin plus chemotherapy, compared to 15 percent in the group receiving chemotherapy alone

    - Side effects were generally manageable. Pulmonary haemorrhage (haemoptysis) cases were observed in 1.9% of the patients receiving Avastin plus chemotherapy. The most common adverse events associated with Avastin monotherapy were: hypertension (5.6%), proteinuria (4.2%), fatigue (5.1%) and dyspnoea (5.6%)

    About Avastin

    Avastin is the first treatment that inhibits angiogenesis - the growth of a network of blood vessels that supplies 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 is the first and only anti-angiogenic agent to have demonstrated improved overall and/or progression-free survival in four major tumour types, namely: colorectal cancer, non-small cell lung cancer, breast cancer and renal cell carcinoma.

    Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma and others) and different settings (advanced and adjuvant i.e. post-operation). The total development programme is expected to include over 40,000 patients 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 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).

    All trademarks used or mentioned in this release are protected by law.

    Additional information

    - Roche in Oncology: www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

    - Roche Health Kiosk, Cancer: www.health-kiosk.ch/start_krebs

    - Avastin: www.avastin.com

    - For b-roll footage and additional information: www.thenewsmarket.com  and search "Avastin"

    [i] Sandler A et al. Paclitaxel-Carboplatin Alone or with Bevacizumab for Non-Small-Cell Lung Cancer. New England Journal of Medicine 2006; 355:2542-50

    [ii] Locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) with histology other than predominant squamous cell

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
For further information please contact: Roche, Dr. Nina
Schwab-Hautzinger, Mobile: +41-79-593-43-07,
nina.schwab-hautzinger@roche.com



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