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

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

September 05, 2007

    SEOUL, South Korea, Sept. 5 /Xinhua-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
http://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
http://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 more information, please contact:

     Lester B. Davis, International Communications Manager
     Tarceva
     Phone: [phone]
     Email: [e-mail]

     Ann Blumenstock
     Resolute Communications
     Phone: [phone]
     Email: [e-mail]