BASEL, March 1 --PRNewswire-AsiaNet/InfoQuest
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
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* 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).
SOURCE: Roche Pharmaceuticals
CONTACT: Emma Robinson or Nina Jones at Resolute Communications
+44-(0)-20-7357-8187, [email protected]
for Roche Pharmaceuticals
Web site: http://www.roche.com
http://www.gene.com
http://www.health-kiosk.ch
--Distributed by AsiaNet (www.asianetnews.net)--