Tarceva(R) Extends Life of Patients with Pancreatic Cancer

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

    BASEL, Switzerland, April 27 /CNW/ - 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(*) 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
    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:

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

    (*). Epidermal Growth Factor Receptor


    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 No.7022), ASCO 2004.

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

    5.  www.cancerhelp.org.uk

For further information:

For further information: Ann Blumenstock, Resolute Communications, Tel:

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