- 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 ( http://www.roche.com ).
All trademarks used or mentioned in this release are protected by law.
Additional information
- Roche in Oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf
- Roche Health Kiosk, Cancer: http://www.health-kiosk.ch/start_krebs
- Avastin: http://www.avastin.com
- For b-roll footage and additional information:
http://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
