Roche
Media Release
Basel, 12 March, 2010
Roche provides update on phase III study of Avastin in men with late stage
prostate cancer
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the topline results of a phase III trial
led by the US Cancer and Leukemia Group B (CALGB) and sponsored by the National Cancer
Institute investigating the use of Avastin (bevacizumab) in combination with docetaxel
chemotherapy and prednisone in men with late stage prostate cancer (hormone-refractory /
HRPC). The study, known as CALGB 90401, did not meet its primary objective of extending
overall survival compared to chemotherapy and prednisone alone. A preliminary assessment of
safety performed by CALGB has shown adverse events that have been previously observed in
pivotal trials with Avastin. Data from the study will be submitted by CALGB for presentation at
the 2010 American Society of Clinical Oncology (ASCO) annual meeting, June 4 to 8, 2010.
"Patients with hormone-refractory prostate cancer are in urgent need of new treatment options. It
is unfortunate that the study did not meet its primary objective, however, we look forward to
sharing the data with the medical community, including the secondary endpoints," said Hal
Barron, M.D., Head Global Development and Chief Medical Officer at Roche.
These findings do not impact Avastin's approved indications, where Avastin has made anti-
angiogenic therapy a fundamental pillar of cancer treatment. Avastin's broad development
programme in other tumour types will also continue as planned.
About prostate cancer
Prostate cancer is the second most commonly diagnosed cancer in men worldwide only after lung
cancer, with over 679,000 men receiving a diagnosis of the disease each year. One third of men
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diagnosed  almost 200,000, will die from their disease.
4070 Basel Corporate Communications Tel. +41 61 688 88 88 4070 Basel
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www.roche.com
About CALGB 90401
CALGB 90401 is a multicentre, randomized, double-blinded, placebo-controlled phase III study
designed to evaluate Avastin plus docetaxel chemotherapy and prednisone compared to docetaxel
chemotherapy and prednisone alone in 1,050 men with hormone-refractory prostate cancer. The
trial is sponsored by the National Cancer Institute (NCI) under a Cooperative Research and
Development Agreement between the NCI and Genentech, and conducted by a network of
researchers led by the CALGB.
The primary endpoint of the study is overall survival. Secondary endpoints of the study include
progression-free survival, prostate-specific antigen response rate, and safety.
Detailed safety assessments are ongoing. A preliminary assessment of safety performed by CALGB
has identified severe adverse events that have been previously observed in pivotal trials with
Avastin, including neutropenia and fatal infections.
About Avastin: Over 5 Years of Transforming Cancer Care
With the initial approval in the USA for advanced colorectal cancer in 2004, Avastin became the
first anti-angiogenic therapy made widely available for the treatment of patients with an advanced
cancer.
Today, Avastin is continuing to transform cancer care through its proven survival benefit (overall
survival and/or progression free survival) across several types of cancer. Avastin is approved in the
US and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small
cell lung cancer and kidney cancer, and Avastin is also available in the US for the treatment of
patients with advanced brain cancer (glioblastoma). Avastin is the only anti-angiogenic therapy
available for the treatment of these numerous advanced cancer types, which collectively cause over
2.5 million deaths each year.
Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today  over
half a million patients have been treated with Avastin so far. A comprehensive clinical programme
with over 450 clinical trials is investigating the use of Avastin in various tumour types (including
colorectal, breast, non-small cell lung, brain, gastric, ovarian, prostate and others) and different
settings (advanced or early stage disease).
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About Avastin: Mode of Action
Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular
endothelial growth factor). VEGF is the key driver of tumour angiogenesis  a fundamental
process required for a tumour to grow and to spread (metastasise) to other parts of the body.
Avastin's precise mode of action allows it to be combined effectively with a broad range of
chemotherapies and other anti-cancer treatments. Avastin helps to control tumour growth and
extend survival with only a limited impact on the side effects of chemotherapy.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with
combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech
company with truly differentiated medicines in oncology, virology, inflammation, metabolism
and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics
and a pioneer in diabetes management. Roche's personalised healthcare strategy aims at providing
medicines and diagnostic tools that enable tangible improvements in the health, quality of life and
survival of patients. In 2009, Roche had over 80'000 employees worldwide and invested almost 10
billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech,
United States, is a wholly owned member of the Roche Group. Roche has a majority stake in
Chugai Pharmaceutical, Japan. For more information:
www.roche.com.
All trademarks used or mentioned in this release are protected by law.
Roche Group Media Relations
Phone: +41 -61 688 8888 / e-mail:
basel.mediaoffice@roche.com
- Alexander Klauser
- Martina Rupp
- Claudia Schmitt
- Nina Schwab-Hautzinger
References
1.
Parkin, DM, et al. Global cancer statistics 2002. CA Cancer J Clin, 2005; 55: 74-108.
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