Media Release
Basel, 22 February 2007
New
phase III study confirms positive outcome of Avastin in patients with advanced lung cancer
Roche
announced today that a phase III study investigating Avastin (bevacizumab) in combination with chemotherapy
met its primary endpoint of improving progression free survival in patients with previously untreated
advanced non-small cell lung cancer (NSCLC), the most common form of the disease. This benefit was seen
in patients who received either one of two different Avastin doses investigated in the trial.
The
results of the phase III "Avastin in Lung" ("AVAiL", BO17704) study showed that
Avastin administered in a schedule of either 7.5 or 15 mg/kg every 3 weeks in combination with gemcitabine/cisplatin
chemotherapy significantly prolonged the time patients with advanced NSCLC lived without their disease
progressing ("progression-free survival") when compared to chemotherapy alone. Although the
study was not designed to compare the Avastin doses, a similar treatment effect in progression-free
survival was observed between the two arms. The benefit and relative safety of each arm will be presented
at an upcoming medical meeting. There were no new safety signals associated with the use of Avastin
at either dose in this clinical setting.
"In addition to supporting
Avastin’s efficacy in advanced lung cancer, these positive results demonstrate Avastin’s treatment benefits
when used in combination with a different chemotherapy regimen than the one investigated in the pivotal
E4599 trial," said William M. Burns, CEO Roche Pharmaceuticals. "We look forward to sharing
the findings with health authorities in Europe and working with them to make Avastin available to patients
with advanced lung cancer as soon as possible."
The results from
BO17704 complement the dossier for the filing of Avastin in NSCLC which was submitted to EU health authorities
in August 2006. In the US, Avastin was approved for the treatment of NSCLC in October 2006.
About
BO17704
BO17704 is an international Phase III trial which includes more than 1000
patients with previously untreated advanced NSCLC, the most common form of lung cancer, with histology
other than predominant squamous cell. The primary objective of the study was to demonstrate superiority
in progression-free survival of both Avastin containing treatment arms versus the control regimen.
About
E4599
In another phase III trial E45991, Avastin was
investigated with a different platinum-based chemotherapy regimen (carboplatin/paclitaxel). 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 a 27 percent improvement in survival compared to
patients receiving chemotherapy alone.
About Lung Cancer
Lung
cancer accounts for 1 in 3 and 1 in 4 cancer-related deaths in men and women, respectively. NSCLC is
the most common form of the disease and accounts for more than 80 percent of all lung cancers, with
histology other than predominant squamous cell as the most common subtype accounting for approximately
60 percent of NSCLC cases. Sadly, the majority of NSCLC cases are 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 months2.
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 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 diseases, 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 drugs for cancer and transplantation and a market leader in virology. 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 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 at
www.roche.com.
All trademarks used or mentioned in this release are protected by law.
Additional information:
- About Genentech
- Roche in Oncology
- Roche Health Kiosk on cancer
To access video clips, in broadcast standard, free of charge, please go to: www.thenewsmarket.com.
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
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.