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Roche Pharmaceuticals

Roche to Present New Survival Data From Phase II, III and IV Studies for Avastin, Herceptin and Xeloda

Basel, Switzerland (ots/PRNewswire)

- Nearly 150 Abstracts Covering New Tumour Types, New Patient
Groups and Existing Indications to Feature in ECCO-ESMO Program
Roche will present encouraging results from nearly 150 scientific
studies  investigating use of its major cancer medicines at ECCO 15
ESMO 34, which  opens in Berlin, Germany today. Overall survival
benefits will be  demonstrated for Avastin(R) (bevacizumab) in
malignant melanoma and for  Herceptin(R) (trastuzumab) in gastric
cancer. In addition, significant  advances in the early treatment of
colon cancer and the treatment of early breast cancer with Xeloda(R)
(capecitabine) in combination with standard chemotherapies will be
shown. Phase IV data for Avastin in lung and breast cancers will also
be presented, confirming that the benefits of targeting VEGF
inhibition are improving patient outcomes in the real-world setting.
"The results from our key studies are extremely encouraging
because they offer new treatment options where very few have existed
for incurable cancers like malignant melanoma, primary brain cancer
and gastric cancer", said William M. Burns, CEO of Roche's
Pharmaceuticals Division. "We also have strong phase II, III and IV
data for Avastin confirming the benefits of targeting VEGF inhibition
to control cancer growth in advanced colorectal, breast and lung
cancers, which continue to claim millions of lives every year", he
Key Avastin Data
Avastin in malignant melanoma (BEAM)
Phase II trial: Encouraging results will be presented from a
trial of Avastin in combination with carboplatin and paclitaxel
chemotherapy in patients with previously untreated advanced malignant
melanoma, a highly aggressive cancer that is incurable and can be
rapidly fatal once it spreads.
Avastin in primary brain cancer (BRAIN)
Phase II trial: Results assessing corticosteroid use and
neurocognitive function in patients with glioblastoma (GBM) at first
or second relapse treated with Avastin will show the positive and
stabilising impact of Avastin in patients with this rare and
aggressive form of primary brain cancer. Most patients experience
relapse or progression of their disease following initial treatment
and when the disease returns, prognosis is very poor. Improving day
to day life for patients is an important treatment aim.
Avastin in metastatic colorectal cancer (BOXER and BEAT)
Phase II trial: Results from BOXER will show the percentage of
patients with liver-only metastases from their colorectal cancer and
unsuitable for upfront liver surgery who will become eligible for
potentially life-saving (curative) surgery when treated with Avastin
plus Xeloda and oxaliplatin (XELOX). The study will also show the
rate of shrinkage or disappearance of liver metastases.
Phase IV trial: BEAT, a large non-randomised trial, will report
on the safety and efficacy of Avastin plus chemotherapy in elderly
patients with metastatic colorectal cancer (mCRC). This is an
important study as older patients are often under-represented in
clinical trials and in mCRC they represent a significant number of
Avastin in lung cancer (SAiL and ARIES)
Phase IV trial: Encouraging final efficacy and safety results
from the SAiL study - an international study in over 2,000 patients
with advanced non-small cell lung cancer (NSCLC) representative of
physician clinical practice will be presented alongside results from
ARIES, a US phase IV study enrolling approximately 2,000 patients
with lung cancer including elderly patients and patients with brain
metastases. Both studies add to the growing body of evidence
supporting use of Avastin first line to progression in order to
maintain optimal disease control.
Avastin in breast cancer (ATHENA and AVADO)
Phase IV trial: ATHENA will confirm the safety and efficacy of
Avastin when combined with taxane or non-anthracycline chemotherapy
in a broad patient population representative of general oncology
practice. The data reinforces the benefits of first-line use of
Avastin in patients with metastatic breast cancer (mBC).
Phase III trial: Minimizing side effects is a key treatment goal
in mBC, so new data from AVADO demonstrating quality of life benefits
for patients who receive Avastin treatment in combination with
docetaxel chemotherapy compared to those who receive placebo and
chemotherapy will be welcome news for physicians and their patients.
Key Herceptin Data
Herceptin in HER-2 positive advanced stomach cancer
Phase III trial: A new and detailed analysis of the Phase III
ToGA study investigating the use of Herceptin added to chemotherapy
in patients with inoperable, locally advanced, recurrent and/or
metastatic HER2-positive stomach cancer will reveal important new
findings for patients whose tumours express a particularly high level
of HER2. Stomach cancer is the second most common cause of
cancer-related death worldwide with over 1,000,000 new cases
diagnosed each year.
Key Xeloda Data
Xeloda in colon cancer (NO16968 / XELOXA)
Phase III trial: The first efficacy results from the XELOXA
adjuvant study, the largest trial completed in patients with Stage
III colon cancer, will show significant disease-free survival
benefits with oral Xeloda in combination with intravenous oxaliplatin
(XELOX) versus 5-FU immediately following surgery.
Xeloda in neo-adjuvant breast cancer
Phase III trial: The independent Austrian Breast Cancer Study
Group (ABCSG-24 trial) will report impressive results from their
study demonstrating the clinical benefit of capecitabine (Xeloda) in
combination with anthracycline and taxane-containing regimens prior
to surgery in women with HER2-positive or HER2-negative early breast
cancer. Additionally, data from three large independent phase III
adjuvant studies, ICE, GAIN and CIBOMA will be presented
demonstrating the potential role of Xeloda-containing therapies in
the adjuvant setting.
About Roche
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For more information please contact: Christine McMenamin, Roche,
+41-79-618-7671; Anne Cameron, Galliard Healthcare, +44-7590-711-190

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