Tarceva(R) Extends Life of Patients with Pancreatic Cancer

Basel, Switzerland (ots/PRNewswire) -

- Newly published results show significant improvement in survival
when innovative, oral cancer drug Tarceva is added to chemotherapy

New results published by the Journal of Clinical Oncology show
that adding Tarceva (erlotinib) to gemcitabine chemotherapy
significantly improves survival by 22 percent in patients with
advanced pancreatic cancer.(1)

This survival increase is impressive as pancreatic cancer is a
particularly fatal form of cancer responsible for over 80,000 deaths
across Europe each year.(2) Despite significant advances in the
treatment of many other tumours, treatment options for pancreatic
patients are extremely limited and until now, no therapies have
demonstrated an improvement in survival for the past decade.

"This study is important because it shows the benefit of a new
approach to treat this deadly disease," said Dr. Malcolm Moore,
Study Chair and Chief of Medical Oncology and Hematology at Princess
Margaret Hospital, University of Toronto. "This is the first study
in ten years to demonstrate an improvement in survival in pancreatic
cancer, and as a physician I'm delighted to have additional
treatment options for my patients."

Data from this study, conducted by the National Cancer Institute
of Canada (NCIC), formed the basis of the recent European approval of
Tarceva for the treatment of patients with metastatic pancreatic
cancer (in combination with chemotherapy) announced in January this
year.

The results showed a statistically significant increase in overall
survival in patients with advanced pancreatic cancer who received
Tarceva plus gemcitabine, compared to patients receiving gemcitabine
alone with an overall 22 percent improvement in survival (p=0.038). A
higher percentage of patients were alive at 12 months in the group
treated with Tarceva plus gemcitabine, compared to those treated with
chemotherapy alone (23% v 17%; p=0.023). Progression-free survival
was also significantly improved for patients treated with Tarceva
(p=0.004).

Pancreatic cancer is the sixth most frequently occurring cancer in
Europe.(4) In 2002, there were more than 78,000 new cases of
pancreatic cancer diagnosed in Europe, with a death rate of
approximately 82,000 people per year.(2) Pancreatic cancer is
difficult to treat as it is often resistant to chemotherapy and
radiotherapy, and tends to spread quickly to other parts of the
body, leading to its high mortality and short life expectancy. Most
people diagnosed with pancreatic cancer have less than one year to
live.(5) This is the second cancer type in which Tarceva has
demonstrated a clear survival benefit and it makes Tarceva the first
and only EGFR(x) targeted treatment to have shown a significant
survival benefit in patients with pancreatic cancer, when added to
gemcitabine, and in patients with non-small cell lung cancer
(NSCLC).(3)

The multi-centre, randomised, double-blind, placebo-controlled
Phase III international study was conducted by the National Cancer
Institute of Canada, Clinical Trials Group at Queen's University
(NCIC CTG) in cooperation with AGITG and investigators in 15 other
countries and co-sponsored by OSI Pharmaceuticals. The study
evaluated Tarceva at 100mg/day or 150mg/day in patients with locally
advanced or metastatic pancreatic cancer. Patients received either
gemcitabine with Tarceva or gemcitabine plus placebo. A total of 569
patients were randomised into the study, with 285 patients receiving
Tarceva plus gemcitabine and 284 patients receiving placebo plus
gemcitabine. Treatment was generally well tolerated in both arms.
Most adverse events associated with Tarceva plus gemcitabine in this
study were mild-to-moderate, and consistent with those observed in
previous clinical trials including rash and diarrhoea.

Tarceva has been approved by the FDA since November 2005 for
treatment of locally advanced, unresectable or metastatic pancreatic
cancer in combination with gemcitabine chemotherapy, and has been
approved for treatment of metastatic pancreatic cancer in the
European Union since January 2007.

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. Early-stage trials of Tarceva are
also being conducted in several other solid tumours as part of the
ongoing research programme.

Notes to Editors

About the Study

The study evaluated Tarceva at 100 mg/day or 150 mg/day in
patients with locally advanced or metastatic pancreatic cancer and
randomised patients to receive either gemcitabine plus concurrent
Tarceva or gemcitabine plus placebo. Gemcitabine was dosed at 1,000
mg/m(2) IV once weekly. Tarceva plus placebo was taken orally at 100
or 150 mg/day until disease progression or unmanageable toxicity.
Approximately 75 percent of the patients in the study had metastatic
disease and 25 percent had locally advanced disease. The study had
sites in the United States, Asia, Canada, Europe, Australia and South
America. The study was conducted by the National Cancer Institute of
Canada Clinical Trials Group based at Queen's University, Ontario in
collaboration with OSI Pharmaceuticals.

About Tarceva

Tarceva (erlotinib) is a small molecule that targets the human
epidermal growth factor receptor (HER1) pathway. HER1, also known as
EGFR, is a key component of this signalling pathway, which plays a
role in the formation and growth of numerous cancers. Tarceva blocks
tumour cell growth by inhibiting the tyrosine kinase activity of the
HER1 signalling pathway inside the cell.

Taken as an oral, once-daily therapy, Tarceva is the only
EGFR-inhibitor to have demonstrated a survival benefit in 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 is approved in the US and across the European Union for
patients with locally advanced or metastatic non-small cell lung
cancer (NSCLC) after failure of at least one prior chemotherapy
regimen. It is also approved in the US for the first-line treatment
of patients with locally advanced, unresectable or metastatic
pancreatic cancer, in combination with gemcitabine chemotherapy, and
in the EU for treatment of metastatic pancreatic cancer.

Tarceva is currently being evaluated in an extensive clinical
development programme by a global alliance among OSI Pharmaceuticals,
Genentech and Roche, focussing on earlier stages of NSCLC.
Additionally, Tarceva is being studied in combination with Avastin in
NSCLC and in a wide variety of other solid tumour types.

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 a supplier of innovative products
and services for the early detection, prevention, diagnosis and
treatment of disease, the Group contributes on a broad range of
fronts to improving people's health and quality of life. Roche is a
world leader in diagnostics, the leading supplier of medicines for
cancer and transplantation and a market leader in virology. In 2005,
sales by the Pharmaceuticals Division totalled 27.3 billion Swiss
francs, and the Diagnostics Division posted sales of 8.2 billion
Swiss francs. Roche employs roughly 70,000 people in 150 countries
and has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and
Chugai. Additional information about the Roche Group is available on
the Internet (www.roche.com).

About Roche: www.roche.com

About Genentech: www.gene.com

About cancer: www.health-kiosk.ch

Roche in Oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e.pdf

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

(x). Epidermal Growth Factor Receptor

References:

BASEL, Switzerland, April 25 /PRNewswire/ --

1. Moore MJ, Goldstein D, Hamm J, et al: Erlotinib plus
gemcitabine compared with gemcitabine alone in patients with advanced
pancreatic cancer: A phase III trial of the National Cancer Institute
of Canada Clinical Trials Group. J Clin Oncol doi:
10.1200/JCO.2006.07.9525.

2. Ferlay J et al. GLOBOCAN 2002: Cancer Incidence, Mortality and
Prevalence Worldwide. IARC CancerBase No. 5, Version 2.0, Lyon; IARC
Press 2004.

3. Shepherd FA, Pereira TE, Ciuleanu EH, et al. A randomized
placebo-controlled trial of erlotinib in patients with advanced
non-small cell lung cancer (NSCLC) following failure of 1st line or
2nd line chemotherapy. A National Cancer Institute of Canada Clinical
Trials Group (NCIC). (Abstract #7022), ASCO 2004.

4. Michaud DS. 2004. Epidemiology of pancreatic cancer Minerva
Chir. Apr; 59(2):99-111.

5. www.cancerhelp.org.uk

ots Originaltext: F.Hoffman-La Roche Ltd.
Im Internet recherchierbar: http://www.presseportal.de

Contact:
Ann Blumenstock, Resolute Communications, Tel: +44-(0)207-397-7484


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