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

Basel, Switzerland (ots/PRNewswire) -

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

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 chemotherapy."

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 cancer.

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 journals.

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 information: http://www.roche.com.

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

Additional information

http://www.roche.com

http://www.thenewsmarket.com (video clips about Tarceva in
broadcast standard, free of charge)

References

(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.

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For further information please contact: George Gauthier at Roche,
Tel:+41(0)61-687-5235; Anna Gray at Galliard, Tel:
+44(0)207-663-2271, Mobile: +44(0)7590-711189