Investor Update
Basel, 14 December 2006
Landmark
study of Avastin in lung cancer published today in New England Journal of Medicine
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 Roche’s innovative cancer medicine
Avastin in helping people with previously untreated advanced NSCLC1 . 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* 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
- Roche Health Kiosk, Cancer
- Avastin
*Locally advanced, metastatic or recurrent non-small cell lung cancer (NSCLC) with histology other than predominant squamous cell
1 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