Avastin® receives positive opinion in Europe for first-line treatment of patients with advanced lung cancer

Basel, July 20, 2007. Roche announced today that the European Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for the first-line use of Avastin in the treatment of the most common form of lung cancer, in combination with platinum-based chemotherapy. The CHMP’s decision is based on data from the pivotal US (E4599) study and another phase III Avastin in Lung (AVAiL) study which together demonstrate that Avastin is effective in combination with a broad chemotherapy range.

Lung cancer is responsible for over 3,000 deaths per day world-wide1 and non-small cell lung cancer (NSCLC) is the most common form of the disease accounting for more than 80 percent of all lung cancers.2 Avastin is the only first-line treatment in over a decade that has been shown to extend the life of patients with advanced lung cancer in a disease for which patients typically have an average life expectancy of only 8 to 10 months.

“This is a significant day for healthcare professionals and patients as it brings access to Avastin, with its proven ability to extend life in an extremely difficult to treat disease, one step closer to reality” said Professor Christian Manegold, Professor of Medicine, Heidelberg University, University Medical Center, Mannheim, Germany and Principal Investigator of the AVAiL study. “I believe that Avastin is such an innovative treatment that it will change not only the current standard of care in NSCLC, but it will also re-write our expectations for patient outcomes.”

Avastin is the first and only anti-angiogenic agent which has been shown to consistently deliver improved overall and/or progression-free survival for colorectal, lung, breast, and kidney cancer patients.

“The CHMP opinion is encouraging news for European patients fighting a particularly aggressive and debilitating disease,” said William M. Burns, CEO Pharmaceuticals Division of Roche. “With our Avastin development program – the biggest trial program in oncology ever – we will continue to develop the best possible treatment approaches to increase survival and improve quality of life of cancer patients.”

In Europe, Avastin was approved in January 2005 and in the US in February 2004 for 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. In October 2006, following priority review, the world’s first angiogenesis inhibitor was approved by the FDA for the treatment of NSCLC. Most recently in April 2007, Avastin was approved in Europe for the first line treatment of women with metastatic breast cancer and in Japan for use in advanced or recurrent colorectal cancer.

About the Phase III studies that formed part of the data pack submitted to the CHMP

E4599 study
The results of the randomised, controlled, multicentre 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 a 25% improvement in overall survival, compared to patients who received chemotherapy alone. Side effects were generally manageable. Pulmonary haemorrhage (haemoptysis) cases were observed in 2.3% 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%).3

AVAiL study
In the double-blind, randomised, controlled, phase III AVAiL study, patients received treatment with either Avastin at 7.5mg/kg or 15mg/kg + cisplatin/gemcitabine or placebo + cisplatin/gemcitabine. The study involved more than 1,000 patients world-wide with previously untreated advanced NSCLC, with histology other than predominant squamous cell. The results show that by adding Avastin to a cisplatin/gemcitabine regimen progression-free survival was significantly prolonged by 20 to 30% compared with chemotherapy alone. No new or unexpected adverse events were observed.

About Lung Cancer
According to the World Health Organization (WHO), lung cancer is the leading cause of cancer-related deaths in both men and women,4 responsible for 19.7 percent of all cancer deaths.5
Lung cancer is the single biggest cancer killer in Europe, claiming 334,800 lives in 2006.5 World-wide, there are more than 1.2 million new cases of lung and bronchial cancer diagnosed each year,4 and new treatment options are urgently needed as the disease has a very high mortality rate.

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.2

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).

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 world-wide.

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

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  

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For more information please contact

Roche
Erica Bersin
+41.61.688.2164 (direct)
+41.79.618.7672 (mobile)

Galliard Healthcare
Jon Harris
+44.0207.663.2261 (direct)

References

1. Kamangar F, Dores GM, Anderson WF. Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol 2006; 24(14): 2137–50.
2. 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.
3. Data on file. Roche, 2006
4. Stewart BW and Kleihues P. World Cancer Report. IARC Press, Lyon, pp.183-7, 2003
5. Ferlay J, et al. Estimates of the cancer incidence and mortality in Europe in 2006. Annals of Oncology. 2007; 18: 581-92.