Investor Update
Basel, 2 November 2005 1
Interim
analysis of phase III trial shows Xeloda plus gemcitabine improved overall survival in patients with
first-line pancreatic cancer
First Xeloda data to show survival
benefit in this deadly cancer
Roche today announced that
an interim analysis of a phase III study of Xeloda (capecitabine) plus standard chemotherapy (gemcitabine)
in first-line pancreatic cancer met its primary endpoint of showing a statistically significant improvement
in overall survival, compared to gemcitabine alone. The study results showed that patients receiving
Xeloda plus gemcitabine had a 20 percent reduction in the risk of death (HR=0.80), compared to gemcitabine
alone. The median survival of patients treated with Xeloda plus gemcitabine was 7.4 months, compared
to 6 months with gemcitabine alone, and 1-year survival rates were 26% and 19% respectively. This trial
was funded and designed by Cancer Research UK and these remarkable findings were unveiled for the first
time at the European Cancer Conference (ECCO) in Paris today.
“This
encouraging Xeloda data provides further survival benefit and quality of life for patients with this
deadly disease and very limited treatment options. The latest results come on top of the recent positive
recommendation by the FDA for Tarceva in pancreatic cancer. In addition, Roche has initiated studies
with Avastin in this disease”, commented William M. Burns, CEO Roche Pharma. “We have also filed Tarceva
in pancreatic cancer in the European Union and other countries worldwide.”
Pancreatic
cancer is one of the most aggressive forms of cancer and is the fifth leading cause of all cancer deaths
in the developed world. Approximately 78,000 new cases of pancreatic cancer are diagnosed per year in
Europe and 30,000 new cases in the US
This phase III study was a
randomized, controlled, multicenter trial that enrolled 533 previously untreated patients with locally
advanced or metastatic pancreatic cancer. The patients were randomized to receive treatment with gemcitabine
with or without Xeloda. The preliminary safety assessments showed that the grade 3/4 toxicity episodes
were anaemia (1% and 2% in arms with and without Xeloda), neutropenia (17% and 11%), thrombocytopenia
(3% and 2%), hand and foot syndrome (2% and 0%) and vomiting (1% and 2%).
“These
data are very exciting and give new hope for pancreatic cancer sufferers who in general have a very
short life expectancy,” said Professor John Neoptolemos, Surgical Oncologist, Division of Surgery and
Oncology, at the Royal Liverpool University Hospital. “Since the study began in May 2002,
I have more patients who are still alive on the Xeloda combination after 12 months and longer - I have
never seen so many patients achieve this before,” he added.
Lead investigator,
Professor David Cunningham said, “This is the first time that adding another cytotoxic drug to gemcitabine
has improved the outcome for patients with inoperable pancreatic cancer and the trial results are therefore
an important milestone. The combination of gemcitabine and capecitabine should now be considered one
of the standard options for patients with advanced pancreatic cancer.“
About
Xeloda
Xeloda is licensed in more than 90 countries worldwide including the EU,
USA, Japan, Australia and Canada. Roche received marketing authorisation for Xeloda as a first-line
monotherapy (by itself) in the treatment of metastatic colorectal cancer (colorectal cancer that has
spread to other parts of the body) in most countries (including the EU and USA) in 2001. Xeloda has
been approved by the European Medicines Agency (EMEA) and U.S. Food and Drug Administration (FDA) for
adjuvant (post surgery) treatment of colon cancer in March and June 2005, respectively. Xeloda is licensed
in combination with Taxotere (docetaxel) in women with metastatic breast cancer (breast cancer that
has spread to other parts of the body) and whose disease has progressed following intravenous (i.v.)
chemotherapy with anthracyclines. Xeloda monotherapy is also indicated for treatment of patients with
metastatic breast cancer that is resistant to other chemotherapy drugs such as paclitaxel and anthracyclines.
Xeloda is licensed for the first-line treatment of stomach cancer that has spread, in South Korea.
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 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss
francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly
65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners,
including majority ownership interests in Genentech and Chugai.
1
References: Ferlay j et al. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevelance Worldwide.
IARC CancerBase No5, version 2.0, Lyon; IARC Press 2004
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Further Information
- Xeloda Factsheet
- Roche in Oncology