Roche Announces Collaboration to Investigate New Treatment Strategy With Tarceva in Lung Cancer

    New Phase III Study Will Evaluate if Tarceva is Superior to Traditional
    Chemotherapy in First Line Treatment of key Group of Patients

    BASEL, Switzerland, April 24 /CNW/ - Roche and the Spanish Lung Cancer
Group (SLCG) today announced their collaboration on the first phase III trial
to investigate Tarceva(R) (erlotinib) in lung cancer patients with genetic
mutations in their epidermal growth factor receptor (EGFR). Over activity of
EGFR is closely associated with the growth and development of lung cancer.
    It has been demonstrated that all patients who do not have the mutations
(called 'wild type') benefit from Tarceva which has been approved in the EU
since September 2005 and in the US since November 2004 for the treatment of
patients with locally advanced or metastatic non-small cell lung cancer
(NSCLC) after failure of at least one prior chemotherapy regimen. Previous
results from smaller trials suggest that tumours with mutations are highly
sensitive to treatment with Tarceva. As many as one in three Asian patients
with lung cancer have EGFR genetic mutations and they are estimated to be
present in 10% of lung cancer patients in the Western population.
    Rafael Rosell from the SLCG commented: "Clinical evidence has already
shown a dramatic response to Tarceva among lung cancer patients with mutations
on the EGFR gene. The identification of EGFR mutations represents a novel
prognostic and predictive strategy in the treatment of lung cancer. This means
that patients with these genetic mutations may benefit from earlier treatment
with Tarceva, which could lead to significant survival benefits. The phase III
EURTAC trial will evaluate whether Tarceva is a superior option for initial
treatment of lung cancer patients with EGFR mutation positive disease than
    The EURTAC trial is the first prospective, randomised phase III trial to
investigate whether first line treatment with Tarceva is superior to
chemotherapy in patients with EGFR mutation positive disease. Tarceva has
already been shown to significantly extend survival and the time patients with
advanced lung cancer live without their cancer getting worse and without the
side effects associated with chemotherapy. The results from EURTAC, if
positive, will support a submission by Roche to the EMEA to seek an additional
new indication for use of Tarceva.

    About EGFR

    The epidermal growth factor receptor - EGFR - is found on the surface of
a cell. When it binds to the cell, it becomes active. It is thought that EGFR
is found in clusters on cells. In some people who have changes or mutations in
their genes, EGFR can become overactive. When EGFR becomes overactive it can
result in uncontrolled cell division, which predisposes an individual to the
development of cancer. EGFR is associated with some forms of cancer, including
lung cancer. Tarceva (erlotinib) is an EGFR receptor inhibitor, and therefore
can block (or dampen) the activity of EGFR. It is because of this mode of
action that Tarceva is thought to be effective in treating patients with lung

    About lung cancer

    Lung cancer is the single biggest cancer killer in Europe, claiming
334,800 lives in 2006(1). Unfortunately, the majority of cases of non-small
cell lung cancer (NSCLC) cases are still diagnosed at an advanced stage when
the cancer is inoperable or has already spread to another part of the body. In
spite of the use of chemotherapy as the first line treatment option, fewer
than 5% of people with advanced NSCLC survive for five years after diagnosis
and most die within 12 months(2).

    About Tarceva

    Tarceva is different from conventional chemotherapies and has been shown
to potently inhibit EGFR. It is the first and only EGFR oral targeted agent in
second line with a proven and significant survival and symptom benefit in a
broad range of patients with advanced lung cancer without the side effects
associated with chemotherapy. Tarceva has been approved in the EU 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 250,000 patients and has
been approved in over 80 countries worldwide.

    About the Spanish Lung Cancer Group

    The Spanish Lung Cancer Group (SLCG) was created in 1991 as an
independent non-profit cooperative group whose aim is to promote the study and
research of lung cancer. The SLCG is comprised of medical oncology
specialists, thoracic surgery specialists, radiotherapy oncology specialists
and basic researchers. It encompasses more than 130 centers, both public and
private, throughout Spain.
    The SLCG has carried out clinical investigation activities in different
types of lung cancer and in diverse clinical situations, from initial to
advanced stages. In their clinical trials, they have treated more than 8,000
patients. Their results have been reported in more than 300 presentations at
international meetings and more than 50 publications in peer-reviewed

    About Roche

    Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in pharmaceuticals and
diagnostics. Roche is the world's largest biotech company with truly
differentiated medicines in oncology, virology, inflammation, metabolism and
CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based
cancer diagnostics and a pioneer in diabetes management. Roche's personalised
healthcare strategy aims at providing medicines and diagnostic tools that
enable tangible improvements in the health, quality of life and survival of
patients. In 2008, Roche had over 80,000 employees worldwide and invested
almost 9 billion Swiss francs in R&D. The Group posted sales of 45.6 billion
Swiss francs. Genentech, United States, is a wholly owned member of the Roche
Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more

    All trademarks used or mentioned in this release are protected by law.

    Additional information (video clips about Tarceva in broadcast
standard, free of charge)


    (1.) Ferlay J, et al. Estimates of the cancer incidence and mortality in
Europe in 2006. Ann Oncol 2007; 18: 581-92.
    (2.) Boyle P and Bernard L. World Cancer Report 2008. IARC Press, Lyon,
pp 309-394, 2008.

For further information:

For further information: George Gauthier at Roche, Tel:
+41(0)61-687-5235; Anna Gray at Galliard, Tel: +44(0)207-663-2271, Mobile:

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