MEDIA RELEASE PR36218
Roche to Present New Survival Data From Phase II, III and IV Studies for Avastin,
Herceptin and Xeloda
BASEL, Sept. 21 / PRNewswire-AsiaNet / --
- 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 added.
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 patients.
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
Information about the Roche Group is available on the Internet at
All trademarks used or mentioned in this release are protected by law.
SOURCE: Roche