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Roche Pharmaceuticals

New Phase III Data Highlights Excellent Efficacy of Roche's Cancer Drugs Xeloda and Avastin for Treatment of Advanced Colorectal Cancer

Basel, Switzerland (ots/PRNewswire)

- New Phase III Data Presented at the American Society of Clinical
Oncology
Gastrointestinal Symposium (ASCO GI) continue to demonstrate the
excellent efficacy of two of Roche's innovative cancer drugs Xeloda
and Avastin, which offer improved survival for patients with advanced
colorectal cancer. The
NO16966 study showed that:
- XELOX (oral Xeloda plus oxaliplatin) is at least as effective as
FOLFOX-4 in terms of overall survival
- The addition of Avastin to either XELOX or FOLFOX leads to a
statistically significant improvement in progression-free survival,
as determined by an independent review committee (IRC)
"Overall, these results confirm the role of XELOX as the most
convenient and patient-friendly treatment option in this disease
area, which is very encouraging for colorectal cancer patients and
healthcare providers," said
Professor Jim Cassidy, co-lead investigator for study NO16966 and
Cancer
Research UK Professor of Oncology and Chair of Medical Oncology,
Beatson Oncology Centre, at the University of Glasgow, Scotland. "In
addition, the independent review confirms that by adding Avastin to
any oxaliplatin-based regimen we can improve progression-free
survival times even further, which we knew all along based on the
second-line data with FOLFOX plus Avastin."
In the treatment of advanced (metastatic) colorectal cancer, these
data showed that XELOX reached its primary endpoint:
  • The chemotherapy combination XELOX is as effective in terms of time patients live without their disease progressing (PFS) as FOLFOX-4.
  • Overall survival data of the first 634 patients enrolled prior to the introduction of Avastin indicate that XELOX is at least comparable to FOLFOX-4.
These data add to the results of previous studies, further
endorsing that
Xeloda should replace infused 5-FU/leucovorin in colorectal cancer
regimens.
The IRC which conducted a blinded analysis of the scans confirmed
that
Avastin reached its primary endpoint:
- The benefit provided by Avastin when added to chemotherapy
(FOLFOX or
XELOX) significantly improved progression-free survival by 43%
compared to chemotherapy alone, as assessed by the IRC. A previous
analysis presented in
October 2006 showed an advantage of 20%.
- Specifically there was also a statistically significant
improvement in
PFS when assessing the addition of Avastin to either the XELOX or
FOLFOX subgroup (p<0.007)
No new safety findings related to Avastin or Xeloda were observed
in the trial.
Further analyses are ongoing and updated results will be presented
at future scientific meetings. Based on findings from this study and
the NO16967 and E3200 studies, Roche will be approaching worldwide
regulatory authorities for new file submissions with Xeloda and
Avastin respectively in advanced colorectal cancer.
In 2004, colorectal cancer was one of the leading cancers and
accounted for 13 percent of all cancers in Europe.(1) A World Health
Organization report suggested that in 2005, 655,000 people worldwide
died from colorectal
cancer.(2)
Notes to Editors:
About the Study
NO16966
NO16966 is a large, international Phase III trial which finally
recruited 2,034 patients. It was originally planned to compare XELOX
vs FOLFOX as first-line treatment in metastatic colorectal cancer:
- XELOX (Xeloda plus oxaliplatin) vs FOLFOX-4 (intravenous bolus
and
infusional 5-fluorouracil plus oxaliplatin)
The two-arm study recruited 634 patients.
After release of the pivotal Avastin data in colorectal cancer in
2003, the protocol was amended to investigate using a 2 by 2
factorial design:
- XELOX + placebo vs XELOX + Avastin (7.5 mg/kg q3w) vs. FOLFOX +
placebo
vs FOLFOX + Avastin (5.0 mg/kg q2w).
The primary objective was to answer two questions: 1) whether the
XELOX regimen is non-inferior to FOLFOX; 2) whether the addition of
Avastin to chemotherapy improved results compared to chemotherapy
alone. The secondary endpoints included overall survival, overall
response rates, time to, and duration of, response and safety
profile.
Results presented previously at the European Society of Medical
Oncology
(ESMO) meeting in October 2006 of the entire study population
(N=2,034) show that:
  • XELOX is as effective as FOLFOX in terms of PFS (hazard ratio: 1.05; upper limit of the 97.5 percent confidence interval was below the non-inferiority margin of 1.23).
  • Adding Avastin to chemotherapy (FOLFOX and XELOX) significantly improved PFS compared to chemotherapy alone (hazard ratio: 0.83). This means that adding Avastin to either chemotherapy combination improves the chances of delaying progression of the disease by 20 percent.
  • No unexpected safety findings were identified for either XELOX or
Avastin:
- Adverse events which occurred at a rate greater than 10 percent
in any of the treatment arms were: diarrhoea (FOLFOX, 11.2 percent of
patients;
XELOX, 20.2 percent of patients), neutropenia (FOLFOX, 43.8
percent of patients, XELOX, 7.0 percent of patients) and neurosensory
toxicity (FOLFOX,
16.5 percent of patients; XELOX, 17.4 percent of patients).
- The percentage of gastrointestinal perforations was 0.6 percent
in the
Avastin arms compared to 0.3 percent in the placebo group. Grade
3/4 arterial thromboembolic events occurred in 1.7 percent vs 1.0
percent respectively.
Grade 3/4 proteinuria was reported for 0.6 percent of all patients
receiving Avastin. Wound healing complications were not observed in a
higher frequency than in the placebo group (0.1 vs 0.3 percent).
About Xeloda (capecitabine)
Xeloda is licensed in more than 90 countries worldwide including
the EU,
USA, Japan, Australia and Canada and has been shown to be an
effective, safe, simple and convenient oral chemotherapy in treating
over 1 million patients to date.
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 also
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 recently received
approval in South Korea for the first-line treatment of patients with
locally advanced (metastatic) pancreatic cancer, in combination with
gemcitabine. Xeloda is licensed in South Korea for the first-line
treatment of stomach cancer.
The most commonly reported adverse events with Xeloda include
diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome
(palmar-plantar
erythrodysesthaesia).
About Avastin (bevacizumab)
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 Vascular Endothelial Growth Factor (VEGF), 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).
In Europe, Avastin was approved in early 2005 and in the US in
February
2004 for first-line treatment of patients with advanced colorectal
cancer. It received another approval in the US in June 2006 as a
second-line treatment for patients with advanced colorectal cancer.
The first filing for Avastin in
Japan occurred in April 2006 for the treatment of advanced
colorectal cancer.
Most recently following priority review, the world's first
angiogenesis inhibitor was approved by the FDA in October for the
treatment of non-small cell lung cancer (NSCLC); a filing for the
same indication was submitted to EU authorities in August.
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.
For more information, please visit www.avastin-info.com
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.
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.
Further Information Available from Media Relations Contacts:
  • Colorectal cancer fact sheet
  • Xeloda in colorectal cancer fact sheet
  • Avastin in colorectal cancer fact sheet
  • Xeloda fact sheet
  • Avastin fact sheet
  • Roche in oncology:
www.roche.com/pages/downloads/company/pdf/mboncology05e_a.pdf
References:
1. Boyle P, Ferlay J. Cancer incidence and mortality in Europe,
2004.
Annals of Oncology 2005;16:481-488
2. World Health Organization,
http://www.who.int/healthinfo/statistics/bodprojections2030/en/ind
ex.html

Contact:

For further information please contact: Julia Pipe, International
Communications Manager, Xeloda, Tel: +41-61-687-4376, Email:
julia.pipe@roche.com. Christine Mage-Hill, Senior International
Communications Manager, Avastin, Tel: +41-79-788-8245, Email:
christine.mage-hill@roche.com

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