Roche Pharmaceuticals

Avastin(R) Significantly Prolongs Progression Free Survival in Patients With Advanced Lung Cancer

    Chicago, Illinois (ots/PRNewswire) -

    - Only First-line Treatment to Demonstrate Extended Survival in Over a Decade

    Avastin (bevacizumab), significantly improves the time patients with advanced non-small cell lung cancer (NSCLC) live without their disease advancing ("progression free survival") when added to cisplatin/gemcitabine chemotherapy, compared with chemotherapy alone. NSCLC is the most common form of the disease and accounts for more than 80 percent of all lung cancers(ii), with histology other than squamous cell as the most common subtype accounting for approximately 60 percent of NSCLC cases. These findings were presented for the first time, today at the 43rd annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

    The results of the Avastin in Lung ("AVAiL", BO17704) trial showed that by adding Avastin to a cisplatin/gemcitabine regimen:

@@start.t1@@      - Progression free survival was significantly prolonged by 20
      to 30 % over chemotherapy alone
      - Tumour response rate was increased by up to 70% compared with
      chemotherapy alone
      - Duration of tumour response was increased from 4.7 to 6.1 months
      compared with chemotherapy alone@@end@@

    "Avastin is the only treatment in over a decade which has extended survival for patients with previously untreated advanced NSCLC as demonstrated by the pivotal E4599 trial. AVAiL now shows that Avastin is also effective when administered with a different chemotherapy regimen" said Professor Christian Manegold, Professor of Medicine, Heidelberg University, University Medical Center, Mannheim, Germany and Principal Investigator of the study. "Lung cancer is an extremely difficult disease to treat and this will give real hope to many patients."

    Two doses of Avastin were investigated in the study (7.5 and 15 mg/kg) and both demonstrated similar benefits. No new or unexpected adverse events were observed. Overall survival data are still pending and will be presented at a future oncology conference.

    Lung cancer accounts for 1 in 3 cancer related deaths in men and 1 in 4 in women. Worldwide, there are more than 1.2 million new cases of lung and bronchial cancer diagnosed each year, (i) and new treatment options are urgently needed as the disease has a very high mortality rate.

    About AVAiL

    The AVAiL study is a randomised, controlled, double-blind Phase III study that includes more than 1,000 patients with previously untreated advanced NSCLC, the most common form of lung cancer, with histology other than squamous cell. The primary objective of the study was to demonstrate superiority in progression-free survival of both Avastin containing treatment arms versus the control regimen.

    In the AVAiL study patients received treatment with either Avastin at 7.5mg/kg or 15mg/kg + cisplatin-gemcitabine or placebo + cisplatin-gemcitabine and a similar treatment effect was observed between the two arms.

    About Lung Cancer

    The majority of NSCLC cases are still diagnosed at an advanced stage when the cancer is inoperable or has already spread to another part of the body. In spite of the use of chemotherapy as the first-line treatment option, less than five percent of people with advanced NSCLC survive for five years after diagnosis and most die within twelve months(i)(ii).

    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 has now demonstrated a progression-free and/or overall survival benefit for patients in four cancer types, namely: colorectal, breast, lung and renal cell cancer.

    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 ie 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 the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide 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 at 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-info.com

    References

    (i) Stewart BW and Kleihues P. World Cancer Report. IARC Press, Lyon, pp.183-87, 2003

    (ii) Wilking N and Jonsson B. A Pan-European comparison regarding patient access to cancer drugs. Karolinska Institute in collaboration with Stockholm School of Economics, Stockholm, Sweden, 2005.

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

Contact:
For more information please contact: Roche, Erica Bersin,
+41-61-688-2164 (direct), +41-79-618-7672 (mobile on-site at ASCO);
Galliard Healthcare, Jon Harris, +44-(0)207-663-2261 (direct)



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