Roche Pharmaceuticals

Tarceva(R) Delivers Benefits Across Broad Range of NSCLC Patients - Confirmed by New Data

Chicago, Illinois (ots/PRNewswire) - - Tarceva Extends Length and Quality of Life in Largest Non-Small Cell Lung Cancer (NSCLC) Phase IV Study Ever Conducted

- For non-US and non-UK Media Only

New data presented at ASCO 2008 from TRUST(1), the largest non-small cell lung cancer (NSCLC) Phase IV trial ever conducted, show that a broad range of NSCLC patients treated with Tarceva (erlotinib) experience clinical benefits including longer survival, better quality of life, control of disease symptoms and control of cancer progression. NSCLC is the most common and deadly form of lung cancer suffered by over one million people worldwide(2).

This analysis of 6,809 patients in 52 countries across Asia, Europe and the Americas showed that Tarceva's beneficial effects are not limited to certain subgroups, but extend to all types of patients with this debilitating disease(1).

Patients across a broad range of clinical characteristics - gender, ethnicity, smoking status or tumor histology1 - lived an average of 14.3 weeks(1) without their disease progressing (progression-free survival or PFS). While TRUST is a single-arm study, a PFS of 14.3 weeks is almost double the PFS (7.2 weeks) seen in the control arm of the landmark BR.21 study(3) which resulted in Tarceva's approval four years ago.

In addition, all patient groups in TRUST (including male current and former smokers, and males who have never smoked) experienced an impressive disease control rate (DCR) of approximately 70% at the time of analysis(1). DCR measures if the tumor disappeared, reduced in size or did not progress, and is strongly associated with increased survival and quality of life.

"These results underline that Tarceva is a very valuable drug with proven efficacy and safety in the fight against NSCLC," said Dr Martin Reck of the Department of Thoracic Oncology, Hospital Grosshansdorf, Germany. "TRUST demonstrates in routine day-to-day practice that Tarceva delivers benefits across a wide range of patients irrespective of clinical characteristics."

Realizing Tarceva's Potential

Another important study unveiled at ASCO is FAST-ACT(4), a phase II trial of Tarceva administered sequentially with platinum-based chemotherapy to Asian patients. The study showed a significant improvement with patients on Tarceva living 7.2 months without their disease progressing. The FAST-ACT study is the first time that an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) has shown promise in first-line NSCLC when administered sequentially with standard chemotherapy. FAST-ACT also points to Tarceva's potential across multiple treatment settings.

In a global alliance comprising OSI Pharmaceuticals, Genentech and Roche, almost 130 clinical studies are being conducted with Tarceva at earlier stages of the disease and in combination with other treatments including Avastin, to further evaluate its life-extending benefits for patients with lung cancer.

For further information and all the latest news on Tarceva and lung cancer, please visit http://www.tarcevapressoffice.com.

Notes to Editor

About TRUST

TRUST, the largest ongoing study of Tarceva in lung cancer worldwide, involves over 7,000 NSCLC patients from 52 countries across Asia, Europe and the Americas. It is a multi-center, global, Phase IV study of Tarceva for the second- or third-line treatment of patients with advanced NSCLC. Also an expanded access program, TRUST enabled thousands of patients worldwide with advanced NSCLC to receive early access to Tarceva by filling the gap between the submission date of the new drug application and the date of final approval.

About FAST-ACT

FAST-ACT is a Phase II randomized, double-blind trial of sequential Tarceva and chemotherapy as first-line treatment in Asian patients with stage IIIB/IV NSCLC. The study involved 154 patients enrolled from Australia, and throughout Asia.

About BR.21

EU approval for Tarceva was based on a pivotal Phase III study, BR.21, published in the New England Journal of Medicine. BR.21 was conducted by the National Cancer Institute of Canada Clinical Trials Group, in collaboration with OSI Pharmaceuticals, with the participation of 86 sites from 17 countries around the world. This study involved 731 patients with advanced NSCLC whose cancers had progressed after first- or second-line chemotherapy and compared patients receiving Tarceva monotherapy with placebo.

    The key study results were:
    - Treatment with Tarceva in patients with advanced NSCLC resulted in
      significantly longer survival compared to placebo, a 42.5% improvement
      (6.7 months vs. 4.7 months).
    - 31% of patients receiving Tarceva were alive at one year compared to
      22% in the placebo arm.
    - Patients receiving Tarceva had stability or control of their lung
      cancer-related symptoms such as cough, shortness of breath and pain,
      for significantly longer.
    - Patients also had a superior quality of life and improved physical
      function compared to those on placebo.
    - The benefits of Tarceva were shown in a broad spectrum of patients 

About Tarceva

Tarceva is the first and only EGFR oral targeted agent with proven and significant survival and symptom benefit in a broad range of patients with advanced 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 than chemotherapy by specifically targeting tumor cells, and avoids most of the typical side-effects of chemotherapy.

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. Furthermore, Tarceva, in combination with chemotherapy, is the first treatment in over a decade to have shown a significant survival benefit in treating patients with pancreatic cancer. It is approved in the US, in combination with gemcitabine, for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer and in the EU for treatment of metastatic pancreatic cancer. Since its initial launch four years ago, Tarceva has been used to treat more than 200,000 patients and has been approved in 85 countries worldwide.

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 tumor 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 NSCLC and Tarceva in pancreatic cancer. For further information on Roche please go to http://www.roche.com.

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 the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. Additional information is available on the internet at http://www.roche.com.

    References
    1. Allan S et al. Efficacy of erlotinib in patients with
       advanced non-small cell lung cancer (NSCLC) relative to clinical
       characteristics: subset analysis from the TRUST study. Poster
       presented at ASCO 2008 Annual Meeting, Chicago, US.
    2. IARC. GLOBOCAN 2002. Cancer incidence, Mortality and
       Prevalence Worldwide.
    3. F. Shepherd 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.
    4. Lee J-S et al. FAST-ACT: a phase II randomized double-blind
       trial of sequential erlotinib and chemotherapy as 1st-line treatment
       in patients with stage IIIB/IV non-small cell lung cancer (NSCLC).
       Abstract #8031: ASCO 2008 Annual Meeting, Chicago, US. 

Contact:

Contact Information For more information on TRUST and Tarceva or to 
arrange an interview with Dr Martin Reck, please contact: Lester B.
Davis International Communications Manager, Tarceva, F. Hoffmann-La
Roche Ltd, Direct: +41-61-688-20-78, Mobile: +41-79-618-76-73,
E-Mail: lester.davis@roche.com ; May Baccari, Resolute
Communications, Direct: +41-61-688-20-78, Mobile: +41-79-618-76-73,
may.baccari@resolutecommunications.com .
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