BN003644 04 de setembro de 2007 16:10 HORALOCAL
SEOUL, Korea, Sept. 4 /PRNewswire/ -- Patients worldwide with
advanced lung cancer can expect longer survival according to new data
from the TRUST study presented at the 12th World Conference on Lung
Cancer (WCLC) in Seoul, Korea. These new worldwide observations show
that patients suffering from non-small cell lung cancer (NSCLC) and
treated with Tarceva (erlotinib) in routine clinical practice are
experiencing longer life. The results from TRUST reinforce the
benefits that patients experienced in the landmark BR.21 study that
earned Tarceva its approval in over 80 countries. Non-small cell lung
cancer is the most common form of lung cancer suffered by over one
million people worldwide.
In BR.21, 31% of patients receiving Tarceva were alive at one year
compared to 22% in the placebo arm and patients experienced a 42.5%
improvement (6.7 months vs. 4.7 months) in length of survival. In
TRUST, data from 6,181 patients reported a median overall survival of
7.5 months. Data on the remaining patients are still being analyzed
and will be announced at a later date.
"The increased survival time in patients from TRUST reinforces what
we are seeing in our clinical practices," said Professor Tony Mok of
the Department of Clinical Oncology, Chinese University of Hong Kong.
"These new data further underscore the drug's potential across a
broad range of lung cancer patients and show that Tarceva enables
patients to spend more quality time with their families and loved
ones."
TRUST is the largest and longest ongoing study ever conducted of
Tarceva. It includes almost 12,000 patients with advanced NSCLC in
over 59 countries in Asia, Europe and the Americas.
Over 182,000 patients worldwide have been treated with Tarceva since
it was launched three years ago. These latest data reinforce that
Tarceva is fulfilling its promise of offering longer survival and
better quality of life to a broad range of patients - men, women,
smokers, non-smokers and people from a wide range of ethnic groups -
with NSCLC, one of the world's most deadly forms of cancer.
"TRUST demonstrates that even in routine clinical practice Tarceva
has comparable efficacy to BR.21," said Dr. Ulrich Gatzemeier, an
investigator for TRUST at the Department of Thoracic Oncology,
Hospital Grosshansdorf, Hamburg, Germany. "This is a great step
forward in the treatment of lung cancer, and one which will offer
hope to many patients and families affected by this disease."
Roche's ongoing commitment to patients
Tarceva is currently being evaluated in an extensive clinical
development program on earlier stages of NSCLC by a global alliance
comprising OSI Pharmaceuticals, Genentech and Roche. Under this
program, almost 20 clinical studies are being conducted with Tarceva
to discover new ways to further increase its life-extending benefits
for patients with lung and other types of cancer. Additionally,
Tarceva is being studied in combination with Avastin in NSCLC and in
a wide variety of other solid tumour types.
"TRUST is just one of the many major clinical trials supported by
Roche currently underway to help identify those patients who can
benefit the most from treatment with Tarceva," said William M. Burns,
CEO of the Pharmaceuticals Division at Roche. "Our focus is to
improve survival rates and quality of life for people suffering from
all types of cancer."
For further information and all the latest news on Tarceva and lung
cancer please visit www.tarcevapressoffice.com
Notes to Editors
About TRUST
TRUST, the largest and longest ongoing study of Tarceva in lung
cancer worldwide, involves nearly 12,000 NSCLC patients from 59
countries across Asia, the Middle East, Europe and the Americas. It
is a multi-center, global, open-label study of Tarceva in lung cancer
patients for the second- or third-line treatment of advanced
non-small cell lung cancer (NSCLC). Also an expanded access program,
TRUST enabled thousands of patients worldwide with advanced NSCLC to
receive early access to Tarceva by filling the gap between the
submission date of the new drug application and the date of final
approval. Since TRUST started in 2004, 93% of the participating
countries received approval of Tarceva as monotherapy for patients
with advanced NSCLC.
About BR.21
EU approval for Tarceva was based on a pivotal Phase III study -
BR.21 - published in the New England Journal of Medicine. BR.21 was
conducted by the National Cancer Institute of Canada Clinical Trials
Group, in collaboration with OSI Pharmaceuticals, with the
participation of 86 sites from 17 countries around the world. This
study involved 731 patients with advanced NSCLC whose cancers had
progressed after first- or second-line chemotherapy and compared
patients receiving Tarceva monotherapy with placebo.
The key study results were:
- Treatment with Tarceva in patients with advanced NSCLC resulted in
significantly longer survival compared to placebo, a 42.5%
improvement (6.7 months vs. 4.7 months).
- 31% of patients receiving Tarceva were alive at one year compared
to 22% in the placebo arm.
- Patients receiving Tarceva had stability or control of their lung
cancer-related symptoms such as cough, shortness of breath and pain,
for significantly longer.
- Patients also had a superior quality of life and improved physical
function compared to those on placebo.
- The benefits of Tarceva were shown in a broad spectrum of patients.
About Tarceva
Tarceva is the first and only EGFR oral targeted agent with proven
and significant survival and symptom benefit in a broad range of
patients with advanced lung and pancreatic cancer. Currently most
lung and pancreatic cancer patients are treated wholly 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 has been approved in the European Union since September 2005
and in the US since November 2004 for the treatment of patients with
locally advanced or metastatic NSCLC after failure of at least one
prior chemotherapy regimen. Furthermore, Tarceva, in combination with
chemotherapy, is the first treatment in over a decade to have shown a
significant survival benefit in treating patients with pancreatic
cancer. It is approved in the US, in combination with gemcitabine,
for the first-line treatment of patients with locally advanced,
unresectable or metastatic pancreatic cancer and in the EU for
treatment of metastatic pancreatic cancer. Since its initial launch
three years ago, Tarceva has been used to treat more than 182,000
patients and has been approved in over 80 countries 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 (1).
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). The Roche Group's cancer medicines generated
sales of more than 7.7 billion Swiss francs in 2004.
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 the world's biggest biotech
company and an innovator of products and services for the early
detection, prevention, diagnosis and treatment of diseases, the Group
contributes on a broad range of fronts to improving people's health
and quality of life. Roche is the world leader in in-vitro
diagnostics and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas such as
autoimmune diseases, inflammation, metabolic disorders and diseases
of the central nervous system. In 2006 sales by the Pharmaceuticals
Division totalled 33.3 billion Swiss francs, and the Diagnostics
Division posted sales of 8.7 billion Swiss francs. Roche has R&D
agreements and strategic alliances with numerous partners, including
majority ownership interests in Genentech and Chugai, and invests
approximately 7 billion Swiss francs a year in R&D. Worldwide, the
Group employs about 75,000 people. Additional information is
available on the Internet at www.roche.com .
Disclaimer: Cautionary statement regarding forward-looking statements
This document contains certain forward-looking statements. These
forward-looking statements may be identified by words such as
'believes', 'expects', 'anticipates', 'projects', 'intends',
'should', 'seeks', 'estimates', 'future' or similar expressions or by
discussion of, among other things, strategy, goals, plans or
intentions. Various factors may cause actual results to differ
materially in the future from those reflected in forward-looking
statements contained in this document, among others: (1) pricing and
product initiatives of competitors; (2) legislative and regulatory
developments and economic conditions; (3) delay or inability in
obtaining regulatory approvals or bringing products to market; (4)
fluctuations in currency exchange rates and general financial market
conditions; (5) uncertainties in the discovery, development or
marketing of new products or new uses of existing products, including
without limitation negative results of clinical trials or research
projects, unexpected side-effects of pipeline or marketed products;
(6) increased government pricing pressures; (7) interruptions in
production; (8) loss of or inability to obtain adequate protection
for intellectual property rights; (9) litigation; (10) loss of key
executives or other employees; and (11) adverse publicity and news
coverage. The statement regarding earnings per share growth is not a
profit forecast and should not be interpreted to mean that Roche's
earnings or earnings per share for any current or future period will
necessarily match or exceed the historical published earnings or
earnings per share of Roche.
End Notes:
- IARC. GLOBOCAN 2002. Cancer incidence, Mortality and
Prevalence Worldwide.
- F. Shepherd, J. Rodrigues Pereira, T. Ciuleanu. et al. Erlotinib in
Previously Treated Non-Small Cell Lung Cancer, A Trial of the
National Cancer Institute of Canada Clinical Trials Group. N Engl J
Med 2005;353:123-32.
SOURCE Roche
09/04/2007
CONTACT: Lester B. Davis, International Communications Manager,
Tarceva, +41-61-688-2078, lester.davis@roche.com; or Ann Blumenstock,
Resolute Communications, +44-20-7357-8187,
ann.blumenstock@resolutecommunications.com
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