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De: PR Newswire
Brasil
Para: THERESA CATHARINA DE GÓES CAMPOS
New Study Suggests Combining Breakthrough
Therapies Tarceva(R) and Avastin(R) May Provide
More Hope for Lung Cancer Patients
05 de junho de 2006 15:51 HORALOCAL
New Study Suggests Combining Breakthrough
Therapies Tarceva(R)
and Avastin(R) May Provide More Hope for Lung
Cancer Patients
BASEL, Switzerland, June 5 /PRNewswire/ -- A new
study(1)
suggests that treatment with the combination of
the innovative cancer
drugs Avastin (bevacizumab) and Tarceva (erlotinib)
or Avastin with
chemotherapy, improves progression-free survival
in patients with
recurrent or refractory non-small cell lung
cancer (NSCLC), the most
common form of lung cancer, when compared with
standard chemotherapy
alone. Progression-free survival is the time
patients live without
their cancer advancing. These data were
presented today at the 42nd
Annual Meeting of the American Society of
Clinical Oncology (ASCO),
Atlanta.
"These findings signal the potential for
combining novel therapies
that target different cancer growth pathways, to
achieve better
overall patient outcomes, with a low incidence
of serious side
effects," said Willem Verhoofstad, Global
Business Director for Roche
Oncology. "We are continuing to invest and
explore the safety and
efficacy of the Avastin and Tarceva combination
and are currently
conducting Phase III trials with both products
in first-line and
relapsed NSCLC settings."
The randomised, Phase II exploratory study
evaluated three treatment
regimens in patients with recurrent or
refractory NSCLC:
-- Avastin in addition to Tarceva
-- Avastin in addition to chemotherapy (either
pemetrexed or
docetaxel)
-- Chemotherapy alone (either pemetrexed or
docetaxel) as control arm
The study suggests that Avastin in combination
with Tarceva or
chemotherapy improves progression-free survival,
the primary study
endpoint, compared to chemotherapy alone. Median
progression-free
survival in the Avastin plus chemotherapy arm
was 4.8 months, and was
4.4 months in the Avastin plus Tarceva arm,
compared to just 3.0
months in the chemotherapy alone arm. The study
results also showed
that the toxicity profile of the Avastin plus
Tarceva combination was
favourable, resulting in fewer serious adverse
events, when compared
to either chemotherapy-containing arm. Due to
the exploratory nature
of this randomised Phase II study, these data do
not provide
definitive conclusions with respect to
differences between the three
treatment arms.
About the Phase II Exploratory Study
120 patients with recurrent or refractory NSCLC,
who had not received
previous treatment with Avastin or Tarceva, were
enrolled into this
study. Patients in the study had histologically
or cytologically
confirmed non-squamous NSCLC and had experienced
clinical or
radiographic disease progression during or
following one
platinum-based chemotherapy regimen for advanced
stage disease (IIIb
or IV).
The key study results showed:
-- Treatment with Avastin plus Tarceva reduced
the risk of cancer
progression or death by 28 per cent compared to
chemotherapy alone
(based on a hazard ratio of 0.72)
-- Treatment with Avastin plus chemotherapy
reduced the risk of
cancer progression or death by 34 per cent
compared to chemotherapy
alone (based on a hazard ratio of 0.66)
-- Treatment with Avastin plus Tarceva saw 78%
of patients alive at
six months (median progression-free survival 4.4
months)
-- Treatment with Avastin plus chemotherapy saw
72% of patients alive
at six months (median progression-free survival
4.8 months)
-- Treatment with chemotherapy alone saw 62% of
patients alive at six
months (median progression-free survival 3.0
months)
-- The toxicity profile of the Avastin plus
Tarceva combination was
favourable, resulting in fewer serious adverse
events, when compared
to either chemotherapy-containing arm
-- Adverse events in the Avastin plus Tarceva
arm were similar to
those observed in previous clinical trials of
Avastin in combination
with
Tarceva, and included diarrhoea and rash
-- Adverse events in the Avastin plus
chemotherapy arm were similar
to those observed in previous clinical trials of
Avastin in
combination with chemotherapy, and included
hypertension and bleeding
About Tarceva
Tarceva is an investigational small molecule
that targets the human
epidermal growth factor receptor (HER1) pathway.
HER1, also known as
EGFR, is a key component of this signalling
pathway, which plays a
role in the formation and growth of numerous
cancers. Tarceva blocks
tumour cell growth by inhibiting the tyrosine
kinase activity of the
HER1 signalling pathway inside the cell.
Taken as an oral, once-daily therapy, Tarceva is
the only
EGFR-inhibitor to have demonstrated a survival
benefit in lung
cancer. Currently most lung cancer patients are
treated with
chemotherapy which can be very debilitating due
to its toxic nature.
Tarceva works differently to chemotherapy by
specifically targeting
tumour cells, and avoids the typical
side-effects of chemotherapy.
Tarceva is approved in the US and across the
European Union for
patients with locally advanced or metastatic
non-small cell lung
cancer (NSCLC) after failure of at least one
prior chemotherapy
regimen. Tarceva is approved in the US in
combination with
gemcitabine chemotherapy for the treatment of
patients with locally
advanced, inoperable or metastatic pancreatic
cancer. A Marketing
Authorisation Application was submitted to the
European health
authorities in November 2005.
Tarceva is currently being evaluated in an
extensive clinical
development programme by a global alliance among
OSI Pharmaceuticals,
Genentech, and Roche, focussing on earlier
stages of NSCLC.
Additionally, Tarceva is being studied in
combination with Avastin in
NSCLC. Trials are also being conducted with
Tarceva in other solid
tumours, such as ovarian, bronchioloalveolar (BAC),
colorectal,
pancreatic, head and neck and glioma (brain).
About Avastin
Avastin is the first treatment that inhibits
angiogenesis -- the
growth of a network of blood vessels that
supplies 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).
Avastin is the first and only anti-angiogenic
agent to have
demonstrated improved overall and/or
progression-free survival in the
three major types of cancer leading to death:
colorectal cancer,
non-small cell lung cancer and breast cancer. In
Europe, Avastin was
approved in early 2005 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
approval by the US Food and Drug Administration
(FDA) in February
2004. In addition, filing occurred in the US on
April 10, 2006, for
use of Avastin in previously untreated advanced
non-squamous,
non-small cell lung cancer, on May 26 for
treatment of women with
advanced breast cancer and in Japan on April 21,
2006 for use of
Avastin in patients with advanced or recurrent
colorectal cancer.
Roche and Genentech are pursuing a comprehensive
clinical programme
investigating the use of Avastin in various
tumour types (including
colorectal, breast, lung, pancreatic cancer,
ovarian cancer, renal
cell carcinoma and others) and different
settings (advanced and
adjuvant i.e. post-operative). The total
development programme is
expected to include over 25,000 patients
worldwide.
Roche in Oncology
The Roche Group, including its members Genentech
in the United States
and Chugai in Japan, is the world's leading
provider of cancer care
products, including anti-cancer treatments,
supportive care products
and diagnostics. Its oncology business includes
an unprecedented five
products proven to provide survival benefit in
different major tumour
indications: Avastin, Herceptin, and Xeloda in
advanced-stage breast
cancer, Herceptin in early-stage HER2-positive
breast cancer,
MabThera in non-Hodgkin's lymphoma, Avastin and
Xeloda in colorectal
cancer, Avastin and Tarceva in non-small cell
lung cancer and Tarceva
in pancreatic cancer.
In addition to these anti-cancer agents, the
Roche oncology portfolio
includes a comprehensive collection of medicines
that can help
improve the quality of life of cancer patients:
Bondronat (for
prevention of skeletal events in patients with
breast cancer and bone
metastases, hypercalcaemia of malignancy),
Kytril (for chemotherapy
and radiotherapy-induced nausea and vomiting),
Neupogen (for
cancer-related neutropenia), and NeoRecormon
(for anaemia in various
cancer settings). CERA is the most recent
demonstration of Roche's
commitment to anaemia management. Other oncology
products include
Furtulon (for colorectal cancer) and Roferon-A
(for hairy cell and
chronic myeloid leukaemia, Kaposi's sarcoma,
malignant melanoma,
renal cell carcinoma).
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.
The unmatched Roche oncology portfolio as well
as an extensive
external innovation base through collaborations
with companies and
academia is what makes it possible for Roche to
provide more
effective cancer therapies.
In the United States Herceptin, MabThera
(Rituxan), 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.
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 improve 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 2005
sales by the Pharmaceuticals Division totalled
27.3 billion Swiss
francs, and the Diagnostics Division posted
sales of 8.2 billion
Swiss francs. Roche employs roughly 70,000
people in 150 countries and
has R&D agreements and strategic alliances with
numerous partners,
including majority ownership interests in
Genentech and Chugai.
Additional information about the Roche Group is
available on the
Internet (http://www.roche.com).
All trademarks used or mentioned in this release
are legally
protected.
Reference:
1) Fehrenbacher, C et al, A phase II,
multicenter, randomized
clinical trial to evaluate the efficacy and
safety of Avastin
(bevacizumab) in combination with either
chemotherapy (docetaxel or
pemetrexed) or Tarceva (erlotinib hydrochloride)
compared with
chemotherapy alone for treatment of recurrent or
refractory non-small
cell lung cancer, Abstract #7062, presented at
the 42nd Annual
Meeting of the American Society of Clinical
Oncology (ASCO) 2006.
SOURCE Roche
06/05/2006
CONTACT: Christine Hill, International
Communications Manager,
Avastin, Roche Pharmaceuticals, Telephone:
+41-616-888-995, Mobile:
+41-797-88-824, Christine.mage-hill@roche.com,
or Martin McInally,
International Communications Manager, Tarceva,
Roche Pharmaceuticals,
Telephone: +41-797-888-208, Mobile:
+41-797-888-208,
martin.mcinally@roche.com
BNED: NG
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FARMACÊUTICA
PALAVRA-CHAVE/EMPRESA: ROCHE
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