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Roche Pharmaceuticals

Avastin Proven Effective Even in Advanced Colorectal Cancer Patients Who Are Unable to Tolerate Aggressive Chemotherapy

Basel, Switzerland (ots/PRNewswire)

- New Study Published Today Provides Further Evidence of the
Benefit of Avastin(R) for Patients With Advanced Colorectal Cancer
Data published for the first time today in the leading Journal of
Clinical Oncology showed that the unique new cancer drug Avastin
keeps cancer under control for a significantly longer duration, even
when used in a group of elderly patients with advanced* colorectal
cancer who are too sick to tolerate traditional aggressive
chemotherapy. Avastin (bevacizumab, rhuMAb-VEGF), when added to a
less aggressive form of chemotherapy, prolonged the time the cancer
was not growing by an extra four months compared to chemotherapy
alone (a 67% increase in progression-free survival).(1)
"The additional four months of median survival that Avastin offers
is of significant clinical benefit for these patients, who are unable
to be treated with other more aggressive traditional chemotherapy
combinations," said Dr Fairooz Kabbinavar, lead study investigator
and Associate Professor at the UCLA School of Medicine, Los Angeles,
USA. "In my opinion, these data indicate that Avastin should be a
part of standard therapy for this group of frail and elderly
patients, who currently have limited chemotherapy treatment options."
"This is an important study as it is the third clinical trial in
which Avastin has shown a major benefit when combined with
chemotherapy to treat advanced colorectal cancer. The growing body of
evidence shows that Avastin not only provides valuable clinical
benefit in first- and second-line settings and with different
chemotherapy regimens, but is also well tolerated by a wide group of
patients receiving treatment for their advanced disease," said Stefan
Manth, Head of Roche Oncology.
Colorectal cancer is the third most commonly reported cancer with
945,000 new cases worldwide each year. It is estimated that over 50%
of people diagnosed with colorectal cancer will die of the
disease.(2)
Study Details
A total of 209 patients, over 65 years old and/or too unfit to
receive a more aggressive chemotherapy, irinotecan, were randomised
to receive a chemotherapy combination they could better tolerate
(5-fluorouracil and leucovorin) with or without Avastin, in the
first-line setting. The Phase II study showed that progression-free
survival was significantly increased in the Avastin group (9.2 months
vs. 5.5 months) compared to those treated with chemotherapy alone.
Overall survival showed an improvement in the Avastin group (median,
16.6 months vs. 12.9 months) as did the response rates (26.0% vs.
15.2%) and the duration of response (9.2 months vs. 6.8 months).
Results from the pivotal Phase III study published in the New
England Journal of Medicine demonstrated significantly longer
survival in patients with previously untreated advanced colorectal
cancer. The study, in which more than 900 patients participated,
showed that Avastin plus chemotherapy increased overall survival by
nearly five months (20.3 months vs. 15.6 months) compared to
chemotherapy alone.(3) The Phase III trial conducted by Eastern
Cooperative Oncology Group (ECOG) also showed a significant increase
in survival in patients with advanced colorectal cancer (12.5 months
vs. 10.7 months) when Avastin was used in combination with a standard
oxaliplatin-containing chemotherapy regimen, compared to chemotherapy
alone. Patients receiving Avastin plus chemotherapy had a 26 percent
reduction in the risk of death (hazard ratio of 0.74).(4)
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).
Avastin received fast-track approval by the US Food and Drug
Administration (FDA) and was launched in the US in February 2004. In
January 2005, the European Commission approved Avastin for the
first-line treatment of patients with metastatic carcinoma of the
colon or rectum in combination with the chemotherapy regimens of
intravenous 5-fluorouracil/folinic acid or intravenous
5-fluorouracil/folinic acid/irinotecan.
Roche in Oncology
Within the last five years the Roche Group, including its members
Genentech in the United States and Chugai in Japan, has become the
world's leading provider of anti-cancer treatments, supportive care
products and diagnostics. Its oncology business includes an
unprecedented five products with survival benefit in different major
tumour indications: Xeloda and Herceptin in advanced stage breast
cancer, MabThera in non-Hodgkin's lymphoma, Avastin in colorectal
carcinoma and Tarceva in non-small cell lung cancer and pancreatic
carcinoma.
In the United States Herceptin, MabThera, Avastin and Tarceva are
marketed either by Genentech alone or together with its partners
Biogen Idec Inc. (MabThera) and OSI (Tarceva). Outside of the United
States, Roche and its Japanese partner Chugai are responsible for the
marketing of these medicines.
The Roche oncology portfolio also includes NeoRecormon (anaemia in
various cancer settings), Bondronat (prevention of skeletal events in
breast cancer and bone metastases patients, hypercalcaemia of
malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and
vomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia,
Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA is
the most recent demonstration of Roche's commitment to anaemia
management. The Roche Group's cancer medicines generated sales of
more than 5.6 billion Swiss francs in the first nine months of 2004.
In addition to the medicines, Roche is developing new diagnostic
tests that will have a significant impact on disease management for
cancer patients in the future. With a broad portfolio of tumour
markers for prostate, colorectal, liver, ovarian, breast, stomach,
pancreas and lung cancer, as well as a range of molecular oncology
tests, Roche will continue to be the leader in providing
cancer-focused treatments and diagnostics.
Roche has four oncology research sites (two in the United States
and one each in Germany and Japan) and five oncology development
sites (two in the United States and one each in UK, Australia and
Switzerland).
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.
All trademarks used or mentioned in this release are legally
protected.
Further information:
About Roche: www.roche.com
About Genentech: www.gene.com
About cancer: www.health-kiosk.ch
To preview and request free B-roll/video content about Avastin,
log onto www.thenewsmarket.com. You can receive broadcast-standard
video digitally, by tape or satellite via the APTN Global Video Wire
from this site. Registration and video on the site is free to the
media.
* Cancer that has spread (metastasised) to other parts of the
body.
References:
(1) Kabbinavar FF, Joseph Schulz J, McCleod M, et al. Addition of
Bevacizumab to Bolus 5-FU/Leucovorin in First-Line Metastatic
Colorectal Cancer: Results of a Randomized Phase II Trial.) J Clin
Oncol 23:10.1200/JCO.2005.05.112, 2005
(2) J. Ferlay, F. Bray, P. Pisani and D.M. Parkin. GLOBOCAN 2000:
Cancer Incidence, Mortality and Prevalence Worldwide, Version 1.0.
IARC CancerBase No. 5. Lyon, IARCPress, 2001
(3) Hurwitz, H, Fehrenbacher, L, Novotny, W, et al. Bevacizumab
plus Irinotecan, Fluorouracil, and Leucovorin for Metastatic
Colorectal Cancer. New England Journal of Medicine 2004; 350(23):
2335-2342
(4) Giantonio BJ et al. The addition of bevacizumab (anti-VEGF) to
FOLFOX4 in previously treated advanced colorectal cancer (advCRC): An
updated interim toxicity analysis of the Eastern Cooperative Oncology
Group (ECOG) study E3200. ASCO Gastrointestinal 2004 Cancer Symposium
(abstract #241).

Contact:

Emma Robinson or Nina Jones at Resolute Communications, Tel:
+44-(0)-20-7357-8187, emma.robinson@resolutecommunications.com

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