Download full document (English - txt) File size=36 Kb

New Avastin® study shows dramatic survival benefits for patients with
metastatic breast cancer
Anti-angiogenic treatment shows survival benefit across three major cancer types: breast,
lung and colorectal cancer
Embargoed until 17.00 EDT, 13 May 2005
ECOG E2100
A new study with Avastin® (bevacizumab, rhuMAb-VEGF) today reported that when used in
combination with chemotherapy, Avastin doubled the chances of surviving without cancer progression in
patients with previously untreated, metastatic breast cancer, compared to chemotherapy alone.1 The data
were presented at the 2005 American Society of Clinical Oncology (ASCO) annual meeting, Orlando,
USA. There are now three cancer types in which Avastin has demonstrated significant clinical benefit.
Multiple studies have shown prolonged overall survival in advanced colorectal cancer, for which Avastin
is indicated, and a new study, also reported today at ASCO, shows longer overall survival in metastatic
non-small cell lung cancer.2 Avastin is the only anti-angiogenic agent to report a survival benefit in any
of these cancer types.
Avastin is the groundbreaking anti-angiogenesis drug that works by choking off the blood supply that is
essential for the growth of the tumour and its spread throughout the body. The latest phase III study
demonstrated that patients treated with Avastin and a standard chemotherapy, paclitaxel, had a significant
increase in median progression-free survival (the amount of time patients lived without their cancer
getting worse) to, on average, 11 months, compared to six months for patients treated with standard
chemotherapy alone. Results from this interim analysis showed a 49% improvement in overall survival
and the overall response rate was 28% in the Avastin group compared to 14% in those treated with
chemotherapy alone.
“This is the very first time we have seen the benefits of an anti-angiogenic therapy in breast cancer,” said Professor
Kathy Miller, lead investigator, Indiana University Cancer Centre, Indianapolis, USA. “The fact that Avastin has
now demonstrated significant clinical benefits in three of the most common types of cancer, colorectal, lung and
breast cancer, highlights how this anti-angiogenesis drug has the potential to completely change the way we treat
cancer, as it could become the mainstay of treatment for a whole range of cancers.”
In women, breast cancer accounts for one fifth of all cancer cases and each year and more than one million new
cases are diagnosed worldwide, with a death rate of approximately 410,000 people per year.3 For colorectal cancer
there are over one million new cases worldwide and over half a million people dying from the disease each year. 3
Lastly, lung cancer is the most common cancer worldwide with 1.3 million new cases annually and over 1 million
deaths occurring each year.3
About the study
The randomised, controlled, multicentre Phase III study was the first to evaluate Avastin in combination
with chemotherapy for the treatment of patients with previously untreated, metastatic breast cancer (firstline). The study was sponsored by the National Cancer Institute (NCI), part of the National Institutes of
Health (NIH), and conducted by a network of researchers led by the Eastern Cooperative Oncology
Group (ECOG). In total, 722 patients were randomised to receive treatment with paclitaxel with or
without Avastin. Patients with HER2-positive metastatic breast cancer were not enrolled in the study
unless they had received prior treatment with Herceptin (trastuzumab) or were unable to receive
treatment with Herceptin. Patients who had received adjuvant paclitaxel within the previous 12 months
and patients with a prior history of blood clots or who were receiving blood thinners were also excluded
from the study.
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).
In Europe, Avastin is approved for 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. Avastin received fast-track approval by the US Food
and Drug Administration (FDA) and was launched in the US in February 2004.*
In the pivotal Phase III study, the addition of Avastin to chemotherapy (irinotecan/5fluorouracil/leucovorin) significantly extended survival by, on average, five months (20.3 months versus
15.6 months) for people with previously untreated metastatic colorectal cancer.4 In a Phase III study with
patients who had previously failed one chemotherapy regimen for their advanced disease, Avastin was
also shown to significantly improve survival, by an average of approximately two months (12.5 months
versus 10.7 months), when added to a widely prescribed oxaliplatin-containing chemotherapy regimen
(oxaliplatin/5-fluorouracil/leucovorin).5
People with very advanced colorectal cancer who are too unwell to tolerate traditional aggressive
chemotherapy also benefit from Avastin. The addition of Avastin to a less aggressive form of
chemotherapy increased progression-free survival by four months, compared to chemotherapy alone (a
67 percent increase).6
A Phase III trial with Avastin in patients with previously untreated advanced non-small cell lung cancer
has shown that adding Avastin to first-line platinum-based chemotherapy (paclitaxel and carboplatin)
significantly increased overall survival from 10.2 months to 12.5 months.2
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
(post operation). As its mechanism may be relevant in a number of malignant tumours, Roche and
Genentech are also investigating the potential clinical benefit of Avastin in pancreatic cancer, ovarian
cancer, renal cell carcinoma and others. Approximately 15,000 patients are expected to be enrolled into
clinical trials over the next few years worldwide.
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
Roche in Oncology: http://www.roche.com/pages/downloads/company/pdf/mboncology05e.pdf
To access video clips, in broadcast standard, free of charge, please go to:
www.thenewsmarket.com
For further information, please contact:
Emma Robinson
Resolute Communications
Ground Floor
The Blue Building
London
SE1 3LA
+44 (0) 20 7357 8187
Note for editors
* In the US, Avastin is approved for use in combination with intravenous 5-fluorouracil-based chemotherapy, for first-line
treatment of patients with metastatic carcinoma of the colon or rectum.
References:
1. Kathy D Miller et al. ECOG E2100 study. Presented at 2005 ASCO Annual Meeting.
2. Sandler AB, Gray R, Bhramer J, et al. Randomized phase II/III Trial of paclitaxel (P) plus carboplatin (C) with or without
bevacizumab (NSC # 704865) in patients with advanced non-squamous non-small cell lung cancer (NSCLC): An Eastern
Cooperative Oncology Group (ECOG) Trial – E4599. ASCO 2005, Abstract LBA4.
3. J. Ferlay, F. Bray, P. Pisani and D.M. Parkin. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide
IARC CancerBase No. 5. version 2.0, IARCPress, Lyon, 2004.
4. 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.
5. Mitchell EP, Alberts SR, Schwartz BJ, et al. High-dose bevacizumab in combination with FOLFOX4 improves survival in
patients with previously treated advanced colorectal cancer: Results from the Eastern Cooperative Oncology Group
(ECOG) study E3200. ASCO Gastrointestinal 2005 Cancer Symposium, January 2005 (abstract 169a).
6. 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