Investor Update
Basel, 15 April 2005 1 1 2 3 4
Interim
analysis shows improved progression-free survival with Avastin for patients with previously untreated
metastatic breast cancer
Third cancer to show benefit with Avastin
Roche
and Genentech, Inc., announced today that Avastin (bevacizumab, rhuMAb-VEGF) in combination with chemotherapy,
significantly improves progression-free survival in patients with previously untreated metastatic breast
cancer. This is in addition to the positive survival benefit with Avastin observed in advanced colorectal
cancer and the recently announced data in locally advanced or metastatic non-small cell lung cancer.
Eight to nine percent of women will develop breast cancer during their
lifetime, making it one of the most common types of cancer in women.
“The
results of this study are outstanding as it is the third cancer where Avastin, in combination with chemotherapy,
has shown significant clinical benefit,” said William M. Burns, CEO of Roche’s Pharmaceutical Division.
“This study underlines the importance of targeting angiogenesis in the therapy of patients with
cancer to significantly improve treatment outcome. We plan to share these data with the regulatory authorities
in order to explore with them how Avastin can be made available to patients with metastatic breast cancer.”
Avastin,
an anti-angiogenesis drug, works by choking off the blood supply that is essential for the growth of
the tumour and its spread throughout the body. The phase III study investigated the use of Avastin
in combination with paclitaxel chemotherapy in patients who had not received any previous treatment
for their metastatic disease (first-line). The companies were advised by the trial group conducting
the study, that an interim analysis of the study showed that it met its primary efficacy endpoint of
improving progression-free survival, the length of time the cancer is stable, compared to chemotherapy
alone.
About the study
This is the
first phase III study to evaluate Avastin in combination with chemotherapy for the first-line treatment
of metastatic breast cancer. This randomised, controlled, multi-centre study enrolled 722 women with
previously untreated metastatic breast cancer. The study was sponsored by the National Cancer
Institute (NCI), part of the National Institutes of Health, and conducted by a network of researchers
led by the Eastern Cooperative Oncology Group (ECOG). The 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. According to ECOG, data from this study will be submitted
to an upcoming medical meeting.
The safety assessment for this trial
is currently being reviewed, but thus far no new signals have been observed. More detailed information
about adverse events will be available when ECOG presents the full data set at an upcoming medical meeting.
Adverse events in this study appeared to be similar to those observed in previous clinical trials with
Avastin in combination with chemotherapy in metastatic breast cancer. Adverse events that occurred more
often in the Avastin arm included neuropathy, hypertension and proteinuria. Serious bleeding and
blood clots were rare in this study. Additional adverse events were similar between the two treatment
arms.
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/5-fluorouracil/leucovorin) significantly extended survival by,
on average, five months (20.3 months versus 15.6 months) for people with previously untreated metastatic
colorectal cancer. Avastin also significantly increased the amount of time the cancer was not growing
compared with patients receiving chemotherapy alone (10.6 months vs. 6.2 months).
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
the length of time the cancer was not growing, by four months, compared to chemotherapy alone (a 67
percent increase in progression-free survival).
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 years worldwide.
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 a world leader in Diagnostics, 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.
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. 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.
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.
3. 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).
4.
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.