Roche Pharmaceuticals

Tarceva(tm) Extends Life for Patients With Pancreatic Cancer

    Basel, Switzerland (ots/PRNewswire) - The addition of Tarceva(tm) (erlotinib) to chemotherapy extends survival by 23.5% for patients with advanced pancreatic cancer, according to data presented today at the American Society of Clinical Oncology (ASCO) Annual Meeting, Orlando, USA.(1) Tarceva, an advanced new cancer drug taken as a once-daily tablet, has already demonstrated a clear survival benefit for patients with advanced non-small cell lung cancer (2) and is the first EGFR-targeted treatment to have shown a significant survival benefit in any type of cancer.

    "Tarceva offers us a new option for the treatment of this dreadful disease. One that is certainly needed after so many years without any improvements in treatment options," said Dr. Malcolm Moore, Study Chair and Medical Oncologist at Princess Margaret Hospital in Toronto. "The survival benefit offered by Tarceva brings new hope to patients and reinforces the potential of EGFR-targeted therapy for the treatment of many different types of cancer."

    The double-blind, placebo-controlled Phase III study, conducted by the National Cancer Institute of Canada, Clinical Trials Group at Queens University (NCIC CTG) in collaboration with OSI Pharmaceuticals, enrolled a total of 569 patients with locally advanced or metastatic pancreatic cancer. The study demonstrated a statistically significant 23.5% improvement in overall survival for patients receiving Tarceva plus gemcitabine compared to patients receiving chemotherapy alone (6.4 months vs 5.9 months). In addition, 24% of patients receiving Tarceva and gemcitabine were alive after one year compared to 17 % of patients receiving only gemcitabine. Progression-free survival for those treated with Tarceva was also significantly improved.(1)

    Pancreatic cancer is the fifth leading cause of cancer deaths in the developing world (3) and is the tenth 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.(3) 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 are told that they may have less than 1 year to live.(5)

    About Tarceva

    Tarceva is an investigational 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.

    Tarceva was approved by the FDA in November 2004, and in Switzerland in March 2005, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

    Tarceva is currently being evaluated in an extensive clinical development program by a global alliance among OSI Pharmaceuticals, Genentech, and Roche. Chugai is pursuing its development and regulatory approval for the Japanese market. In the United States, Tarceva is jointly marketed by Genentech and OSI Pharmaceuticals.

    Roche in Oncology

    The Roche Group, including its members Genentech in the United States and Chugai in Japan, is the world's leading provider of cancer care products, including anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented five products proven to provide survival benefit in different major tumour indications: Avastin, Herceptin, and Xeloda in advanced-stage breast cancer, Herceptin in early-stage HER2-positive breast cancer, MabThera in non-Hodgkin's lymphoma, Avastin and Xeloda in colorectal cancer, Avastin and Tarceva in non-small cell lung cancer and Tarceva in pancreatic cancer.

    In addition to these anti-cancer agents, the Roche oncology portfolio includes a comprehensive collection of medicines that can help improve the quality of life of cancer patients: Bondronat (for prevention of skeletal events in patients with breast cancer and bone metastases, hypercalcaemia of malignancy), Kytril (for chemotherapy and radiotherapy-induced nausea and vomiting), Neupogen (for cancer-related neutropenia), and NeoRecormon (for anaemia in various cancer settings). CERA is the most recent demonstration of Roche's commitment to anaemia management. Other oncology products include Furtulon (for colorectal cancer) and Roferon-A (for hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). The Roche Group's cancer medicines generated sales of more than 7.7 billion Swiss francs in 2004.

    In addition to the medicines, Roche is developing new diagnostic tests that will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, Roche will continue to be the leader in providing cancer-focused treatments and diagnostics.

    The unmatched Roche oncology portfolio as well as an extensive external innovation base through collaborations with companies and academia is what makes it possible for Roche to provide more effective cancer therapies.

    In the United States Herceptin, MabThera (Rituxan), Avastin and Tarceva are marketed either by Genentech alone or together with its partners Biogen Idec Inc. (MabThera) and OSI (Tarceva). Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these medicines.

    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 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

    All trademarks used or mentioned in this release are legally protected.

    Further information:

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    1. Moore MJ, Goldstein D, Hamm J, et al. Erlotinib plus gemcitabine compared to gemcitabine alone in patients with advanced pancreatic cancer. A phase III trial of the National Cancer Institute of Canada Clinical Trials Group [NCIC-CTG]. (Abstract #1), ASCO 2005.

    2. Shepherd F, et al. A randomised 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.

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



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