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

2006-12-14 09:28 873

- Avastin is First Medicine to Extend Survival Beyond One Year in Patients

with Previously Untreated Non-Small Cell Lung Cancer

BASEL, Switzerland, Dec. 14 /Xinhua-PRNewswire/ -- 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 Roche's 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 ( ).

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

Additional information

- Roche in Oncology:

- Roche Health Kiosk, Cancer:

- Avastin:

- For b-roll footage and additional information: 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;


[ii] Locally advanced, metastatic or recurrent non-small cell lung cancer

(NSCLC) with histology other than predominant squamous cell

Source: Roche Pharmaceuticals