Investor Update
Basel, 8 August 2006
Avastin
filed in
Europe for treatment of most common form of lung cancer
First medicine to extend
survival
of previously untreated patients beyond one year
Roche announced today
that it has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMEA)
for the use of its innovative cancer medicine Avastin in addition to platinum-based chemotherapy for
the first-line treatment of the most common form of lung cancer - non-small cell lung cancer (NSCLC)
in patients with a certain cell type. The filing is based on data from the pivotal US (E4599) trial
which showed a strong survival benefit for patients treated with Avastin plus chemotherapy compared
to chemotherapy alone, as well as preliminary data from the ongoing AVAiL trial.
This
signals new reason for hope in Europe, where lung cancer claims more than 900 lives per day, making
it the leading cause of cancer-related deaths.1 Few effective treatment options
exist. Avastin was submitted
in April in the US for NSCLC with histology other than predominant squamous cell and is currently undergoing
priority review.
Avastin is the first biological therapy to show survival
benefit in people with previously untreated non-small cell lung cancer,” said Eduard Holdener, Head
Global Drug Development. “Providing patients with novel treatment options to help them fight their disease
is a priority for Roche, so we are very pleased to take the next step in making Avastin available to
patients with this particularly devastating form of cancer”.
After colorectal
and breast cancer, lung cancer is the third type of cancer in which the anti-angiogenic agent Avastin
has demonstrated significant survival benefit. In Europe, Avastin was approved in January 2005 and in
the US in February 2004 for the first-line treatment of patients with metastatic colorectal cancer in
combination with IV 5-FU-based chemotherapy. It received another approval in the US in June 2006 as
a second-line treatment for patients with metastatic colorectal cancer in combination with IV 5-FU-based
chemotherapy. The first filing for Avastin in Japan occurred in April 2006 for the treatment of advanced
colorectal cancer. More recently, Avastin was filed for the treatment of women with advanced breast
cancer in the EU in July 2006, which followed the US May 2006 filing of Avastin in combination with
taxane chemotherapy for patients who have not previously received chemotherapy for their locally recurrent
or metastatic breast cancer.
About the pivotal (E4599)
study
The
EU filing of Avastin in NSCLC is based on impressive data from the randomised, controlled, multicenter
Phase III study E4599. These study results have been accepted for publication in the New England Journal
of Medicine.
The results of the E4599 study of 878
patients
with locally
advanced, metastatic or recurrent NSCLC with histology other than predominant squamous cell show that:
- Patients treated with Avastin plus paclitaxel and carboplatin chemotherapy had a 20 percent reduction in the risk of death at any time of the study conduct, compared to patients receiving chemotherapy alone.
- Median survival of patients treated with Avastin at a dose of 15mg/kg every three weeks plus chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone3
- Median time patients lived without their disease advancing (“progression free survival”) was increased by 33%: 6.4 months for patients treated with Avastin plus chemotherapy, compared to 4.8 months for patients treated with chemotherapy alone
- Response rate in patients with measurable disease was 29 percent in the group receiving Avastin plus chemotherapy, compared to 13 percent in the group receiving chemotherapy alone
- Pulmonary haemorrhage (haemoptysis) cases were observed in 2.3% of the patients receiving Avastin plus chemotherapy
About
AVAiL
AVAiL
is a randomised, controlled, multicenter international Phase III trial planning to enrol 1,050 patients
with previously untreated advanced non-squamous NSCLC with histology other than predominant squamous
cell to explore two doses of Avastin (7.5 or 15 mg/kg every 3 weeks) in combination with a platinum
doublet (gemcitabine/cisplatin) chemotherapy. The primary objective of the study is to demonstrate superiority
in progression-free survival of both Avastin containing treatment arms versus control.
Preliminary
data from AVAiL was submitted for regulatory purposes only to support the EU filing. The study blind
has not been broken and final AVAiL data are expected in 2007. Only then will conclusions be drawn on
the efficacy of the two doses of Avastin used in AVAiL.
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 stage2
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 ie 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
- Lung Cancer
- Roche in Oncology
- Roche Health Kiosk, Cancer
References
1.Boyle
P and Ferlay J. Cancer incidence and mortality in Europe, 2004. Annal Oncol: 16; 481-488, 2005.
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.
3.
Sandler AB, Gray R, Bhramer J, et al. Randomized phase II/III Trial of paclitaxel (P) plus carboplatin
(C) with or without bevacizumab (NSC # 704865) in patients with advanced non-squamous non-small cell
lung cancer (NSCLC): An Eastern Cooperative Oncology Group (ECOG) Trial – E4599. ASCO 2005, Abstract
LBA4.