F.Hoffman-La Roche Ltd.

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


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

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