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Roche Pharmaceuticals

Unique Cancer Drug Avastin Now Shown to Improve Survival Across Different Metastatic Colorectal Cancer Regimens

Basel, Switzerland, November 30 (ots/PRNewswire)

Roche and
Genentech, Inc., announced today that Avastin(TM) (bevacizumab,
rhuMAb-VEGF), a new innovative anti-angiogenesis drug, has shown for
the first time that it significantly increases survival in patients
with metastatic colorectal cancer when used in combination with a
standard oxaliplatin-containing chemotherapy regimen. These patients
had previously failed one chemotherapy regimen for their advanced
disease.
Preliminary results have shown the study has achieved its primary
endpoint showing that patients who received Avastin plus chemotherapy
lived nearly two months longer, on average, compared to those who
received chemotherapy alone (12.5 months vs 10.7 months). Patients
receiving Avastin plus chemotherapy had a 26 percent reduction in the
risk of death (hazard ratio of 0.74). Oxaliplatin-containing
chemotherapy regimens are widely used in first- and second-line
metastatic colorectal cancer therapy.
Colorectal cancer is the third most commonly reported cancer, with
945,000 new cases annually worldwide. It is estimated that more than
50% of people diagnosed with colorectal cancer will die of the
disease. [1]
"We are delighted with this news," said William M. Burns, Head of
Roche Pharmaceuticals Division. "This is the first time that data
have demonstrated the significant survival benefit that Avastin can
also bring to patients whose disease progresses after initial
anti-tumour treatment. Today's data highlight the potential of
Avastin for many patients with metastatic colorectal cancer, as it
has now shown survival benefit when used in either first- or
second-line."
The randomised, controlled, multi-centre Phase III study,
sponsored by the National Cancer Institute, part of the National
Institutes of Health, and conducted by a network of researchers led
by the Eastern Cooperative Oncology Group (ECOG), is the first
large-scale study to evaluate Avastin in combination with an
oxaliplatin-containing chemotherapy regimen (FOLFOX4)*. It is also
the first large-scale study in patients with metastatic colorectal
cancer who had failed a previous chemotherapy regimen (relapsed). A
total of 829 patients were enrolled in this trial and were randomised
to receive treatment with FOLFOX4 with or without Avastin. According
to ECOG, preliminary study results will be presented during the ASCO
Gastrointestinal Cancers Symposium, January 27-29, 2005 in Hollywood,
Florida. Trials investigating the use of Avastin with an
oxaliplatin-containing regimen as adjuvant (post operation) treatment
and first-line treatment for patients with metastatic colorectal
cancer are currently ongoing.
"These trial results are immensely important because they provide
striking evidence that Avastin can be safely combined with the many
different chemotherapy regimens commonly used in the treatment of
advanced colorectal cancer," commented Stefan M. Manth, Head of Roche
Oncology.
Avastin received fast-track approval by the US Food and Drug
Administration (FDA) and was launched in the US in February 2004. In
October 2004, Roche received a positive recommendation from the
European Committee for Medicinal Products for Human Use (CHMP) for
Avastin for first-line treatment of patients with metastatic
carcinoma of the colon or rectum in combination with intravenous
5-fluorouracil (5-FU)/folinic acid or intravenous 5-FU/folinic
acid/irinotecan. Avastin will now be proposed for final marketing
approval by the European Commission.
Roche and Genentech are pursuing a comprehensive clinical
programme investigating the use of Avastin in advanced colorectal
cancer with other chemotherapies and also expanding into the adjuvant
setting. As Avastin's mechanism may be relevant in a number of
malignant tumours, Roche and Genentech are also investigating the
potential clinical benefit of Avastin in other cancers, including
non-small cell lung cancer, pancreatic cancer, renal cell carcinoma
and others. Approximately 15,000 patients are expected to be enrolled
into clinical trials over the next years worldwide.
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).
Earlier this year, the New England Journal of Medicine published
results of a pivotal Phase III study which demonstrated that the
addition of Avastin to standard IFL chemotherapy
(irinotecan/5-FU/leucovorin) significantly extends 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.[2]
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 research sites (two in the United States and one
each in Germany and Japan) and five 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-intensive healthcare groups. Its core businesses are
pharmaceuticals and diagnostics. As a supplier of innovative products
and services for the 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 one of the world's
leading companies in the global diagnostics market, the leading
supplier of medicines for cancer and transplantation and a market
leader in virology. In 2003, the Pharmaceuticals Division generated
19.8 billion Swiss francs in prescription drug sales, while the
Diagnostics Division posted sales of 7.4 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.
Notes to Editor:
* FOLFOX4 is a standard chemotherapy combination with
oxaliplatin, 5-fluorouracil and leucovorin.
Further information:
References:
[1] 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
[2] 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

Contact:

Media Relations Contacts: Phone: +41-61-688-88-88 / e-mail:
basel.mediaoffice@roche.com - Baschi Dürr - Alexander Klauser -
Daniel Piller(Head Roche Group Media Office) - Katja Prowald (Head
Science Communications) - Martina Rupp

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