Tarceva(R) Extends Life of Patients with Pancreatic Cancer

Tarceva(R) Extends Life of Patients with Pancreatic Cancer

April 26, 2007

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

    BASEL, Switzerland, April 26 /Xinhua-PRNewswire/ -- 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: http://www.roche.com

    About Genentech: http://www.gene.com

    About cancer: http://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:
    
    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. http://www.cancerhelp.org.uk


    For more information, please contact: 

     Ann Blumenstock
     Resolute Communications
     Tel: [phone]