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13.07.2005 – 23:20

Roche Pharmaceuticals

New Cancer Drug Tarceva(R) Demonstrates Significant Improvement in Survival, Symptoms and Quality of Life in Lung Cancer Says Landmark New England Journal of Medicine Study

    Basel, Switzerland (ots/PRNewswire)

    - Results Provide New Hope in Fight Against One of the Most Deadly Cancers

    Treatment with the innovative cancer drug Tarceva(R) in patients with advanced non-small cell lung cancer (NSCLC) resulted in significantly longer survival compared to placebo (42.5% improvement) according to a landmark study published in the New England Journal of Medicine (NEJM) today. The study also showed an improvement of symptoms and quality of life in patients treated with Tarceva.(1)

    The results provide new hope in the fight against one of today's most deadly cancers. NSCLC is the most common form of lung cancer with around one million new cases worldwide each year.(2,3) Few treatment options exist and mortality is exceptionally high.

    "This study is an important medical advance for patients with advanced lung cancer and publication in an eminent journal such as the NEJM is testament to the significance of the data," stated Study Chair, Frances A. Shepherd, M.D., FRCPC, Scott Taylor Chair in Lung Cancer Research and Medical Oncologist at the Princess Margaret Hospital, Professor of Medicine at the University of Toronto. "Current treatment options are limited and their side-effects can be debilitating. This landmark study showed that Tarceva not only prolongs survival but also provides new hope by improving lung cancer symptoms and patients' quality of life."

    Tarceva is an oral, once-daily therapy from a novel class of anti-cancer drugs known as 'EGFR inhibitors' (epidermal growth factor receptor inhibitors) and it is the first EGFR inhibitor to have demonstrated a survival benefit in cancer.

    Study Design/Outcome

    The global study was conducted by the National Cancer Institute of Canada Clinical Trials Group based at Queen's University and involved 86 sites from 17 countries around the world. This Phase III study (NCIC-CTG BR.21) involved 731 patients with advanced NSCLC whose cancers had progressed after first- or second-line chemotherapy. The study compared patients receiving Tarceva monotherapy with placebo. Patients taking Tarceva showed a significant improvement in survival (6.7 months vs 4.7 months). In addition, 31% of patients receiving Tarceva were alive at one year compared to 22% in the placebo arm. Patients receiving Tarceva also had stability or control of their lung-cancer related symptoms for significantly longer and had a superior quality of life and improved physical function compared to those on placebo.(1)

    Based on this trial data, Tarceva was approved by the FDA in November 2004, in Switzerland in March 2005 and in Canada in July 2005, for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. Tarceva has recently received a positive recommendation from the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of locally advanced or metastatic NSCLC.

    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. Similarly to the significant survival benefit in NSCLC, Tarceva has also shown survival benefit in a Phase III study in locally advanced or metastatic pancreatic cancer patients. The study met its primary endpoint of improving overall survival. Tarceva is currently being evaluated in an extensive clinical development programme 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.


    1. Shepherd F, Rodrigues Pereira J, Ciuleanu T. et al. Erlotinib in Previously Treated Non-Small Cell Lung Cancer, A Trial of the National Cancer Institute of Canada Clinical Trials Group. N Engl J Med 2005;353:123-32.

    2. Ferlay J, Bray F, Pisani P and Parkin DM. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide IARC CancerBase No. 5. version 2.0, IARCPress, Lyon, 2004.


    Further information:

    About Roche:

    About Genentech:

    About cancer:

    Roche in Oncology:

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