Roche's Tarceva(R) Delivers Longer Life for Lung Cancer Patients



    SEOUL, Korea, Sept. 4 /CNW/ - 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.
    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.
    





For further information:

For further information: Lester B. Davis (International Communications
Manager, Tarceva), Phone: +41-61-688-2078, e-mail: lester.davis@roche.com; Ann
Blumenstock (Resolute Communications), Phone: +44-20-7357-8187, email:
ann.blumenstock@resolutecommunications.com

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