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.de

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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