Investor Update
Basel, 25 September 2007
Positive
Xeloda five-year overall survival study data in the adjuvant treatment of colon cancer presented at
leading European cancer meeting
Five-year follow-up overall survival
data from the X-ACT (Xeloda in Adjuvant Colon Cancer Trial) study show that oral chemotherapy Xeloda
(capecitabine) is as effective as the current standard treatment – intravenous bolus 5-FU/LV (5-fluorouracil/leucovorin)
– in the adjuvant treatment of Dukes’ C colon cancer. These data were presented today at the 14th European
Cancer Conference (ECCO) in Barcelona, Spain.
Results show five-year
overall survival rates for Xeloda at 71.4 percent compared to 68.4 percent in the 5-FU/LV arm. Additional
data presented at the meeting from a previous analysis show that Xeloda is also comparable to 5-FU/LV
with respect to disease-free survival (DFS) and relapse-free survival (RFS).
“These
updated five-year overall survival data provide further proof that Xeloda can be a safe and effective
alternative to the current standard of care for adjuvant colorectal cancer, which can require upwards
of 30 clinic visits over the 24-week treatment course,” said Dr. Howard Burris of the Sarah Cannon Research
Institute, Nashville, Tenn., and lead U.S. investigator in the study. “Based on this evidence, physicians
– especially those who have relied on 5-FU/LV – should feel confident about exploring Xeloda as a treatment
option with their patients who could benefit from the flexibility of oral chemotherapy.”
Previous
results from the X-ACT study also show that Xeloda is more cost-effective than the Mayo Clinic regimen
(the current standard treatment) and is associated with fewer side effects. Additionally, many of the
side effects can be easily managed by altering the dose without compromising efficacy1,2.
In the same analysis, costs for medicines to treat side effects, such as nausea and diarrhea, were cut
by nearly 75 percent in the Xeloda arm compared to use of intravenous 5-FU/LV.
“We
are
pleased to see that Xeloda is standing up to its initial promise as an alternative to 5-FU/LV,” said
Lars Birgerson, Vice President, Medical Affairs, Roche. “Roche is committed to providing colon cancer
patients with the safest and most effective treatment options that allow patients to continue their
active lifestyles.”
Colorectal cancer is the third most common cancer
in the United States. The American Cancer Society estimates that in 2007 more than 153,500 people in
the U.S. will be diagnosed and about 52,000 people will die from the disease, accounting for almost
10 percent of all cancer deaths. When colorectal cancer is detected at an early, localized stage, the
five-year survival is 90 percent; however, only 39 percent of colorectal cancers are diagnosed at this
stage, mostly due to low rates of screening.
About the
X-ACT Trial
The international, Phase III X-ACT trial enrolled 1,987 patients (1,004
patients were randomly assigned to Xeloda; 983 patients were assigned to intravenous 5-FU/LV) who were
treated for a period of 24 weeks between 1998 and 2001 at 164 centers worldwide. The primary study objective
was to show equivalence in disease-free survival between Xeloda and intravenous 5-FU/LV. Secondary objectives
included: relapse-free survival, overall survival and safety. Xeloda three-year disease-free survival
and relapse-free survival rates demonstrated non-inferiority to 5-FU/LV (intent-to-treat analysis, P
< 0.0001; P=0.0407, respectively). Xeloda was associated with fewer adverse events than 5-FU/LV (P
< 0.001). With a median follow-up of 7 years, updated study results presented at ECCO show five-year
overall survival rates for Xeloda at 71.4 percent compared to 68.4 percent in the 5-FU/LV arm.
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 the world’s
biggest biotech company and an innovator of 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 the world leader in in-vitro diagnostics and drugs for cancer and
transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune
diseases, inflammation, metabolic disorders and diseases of the central nervous system. 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 has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and Chugai, and invests approximately
7 billion Swiss francs a year in R&D. Worldwide, the Group employs about 75,000 people. Additional
information is available on the Internet at www.roche.com.
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trademarks used or mentioned in this release are protected by law.
1)
Cassidy J, et al. Annals of Oncology 2002; 13: 566-575
2) Blum J, et al. Cancer 2001;
92(7): 1759-1768