Investor Update
Basel, 27 June 2006
US
Phase III study of Avastin in advanced pancreatic cancer does not meet primary endpoint
Roche
and Genentech remain committed to broad Avastin development programme
Roche
announced that a US Phase III trial of Avastin (bevacizumab) in combination
with gemcitabine chemotherapy as first-line treatment for advanced pancreatic cancer did not meet its
primary endpoint of overall survival. The decision to stop the trial was taken following a recommendation
of an independent data monitoring board based on an interim analysis indicating that it is very unlikely
that significant differences in overall survival will be shown between treatment arms as the data mature.
The study was not stopped due to safety events and no new safety concerns related to Avastin were observed
in this trial. The existing filings and approvals in colorectal, lung and breast cancer are not affected.
Pancreatic
cancer is recognized as one of the most aggressive and most difficult-to-treat forms of cancer.
“Pancreatic
cancer has a very high mortality and a short life expectancy and treatments that may improve survival
are desperately needed. We will be further evaluating the data to understand potential reasons why this
combination therapy did not lead to a clinical benefit in this trial”, said Eduard Holdener, Head of
Global Development at Roche. “In addition, we will continue with the large Avastin development programme
and investigate the medicine in a broad range of cancers including another study in pancreatic cancer
where Avastin is added to a standard regimen and Tarceva. It is important to note that Avastin is the
first and only anti-angiogenic therapy with demonstrated significant survival benefits in the three
most common cancer types: colorectal, lung and breast cancer.”
The US
phase III trial was sponsored by the NCI (National Cancer Institute) and NCI collaborators and investigators
working on other Avastin pancreatic cancer trials will be notified of this development.
Roche
and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in 25
cancer types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma,
prostate cancer and others) across different settings. The trial programme also involves less prevalent
and other difficult-to-treat cancers. The total development project is expected to include over 40,000
patients worldwide.
In Europe, Avastin was approved in early 2005 and
in the US in 2004 for first-line treatment of patients with advanced colorectal cancer. Avastin was
filed in April this year in the US for the most common form of lung cancer. The first filing for Avastin
in Japan has been submitted in April 2006 for the treatment of advanced colorectal cancer. Most recently
on May 26, 2006 Avastin was filed in the US for the treatment of women with advanced breast cancer.
About
CALGB 80303
This randomized, controlled, multi-center trial of 602 advanced pancreatic
cancer patients was sponsored by the National Cancer Institute (NCI), and conducted by a network of
researchers led by the Cancer and Leukemia Group B (CALGB). Patients enrolled were randomized to receive
treatment with gemcitabine with or without Avastin as a first-line therapy. Patients who had received
prior chemotherapy for metastatic disease, adjuvant chemotherapy within the previous four weeks or any
prior treatment with gemcitabine or Avastin in the adjuvant or metastatic setting were excluded from
enrolling in the study. Patients with a prior history of bleeding events and those who experienced a
surgical procedure, open biopsy, or significant traumatic injury during the prior 28 days were also
excluded from the study. The statistical plan included pre-specified futility analyses that were conducted
and reviewed by an independent Data Monitoring Board.
About
AVITA
AVITA (BO17706) is a Roche-sponsored randomised, double blind, placebo controlled
study of Gemcitabine and Tarceva+/- Avastin in patients with metastatic pancreatic cancer. The first
patient was enrolled on 18 July 2005 and recruitment is expected to end before the end of 2006.
Based
on an unblinded efficacy and safety analysis conducted in April 2006, the independent Data Safety Monitoring
Board (DSMB) recommended that the study continues as planned.
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).
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 legally protected.