Healthcare Industry News:  non-small cell lung cancer 

Biopharmaceuticals Oncology

 News Release - September 4, 2007

Roche's Tarceva(R) Delivers Longer Life for Lung Cancer Patients

SEOUL, Korea, Sept. 4 (Healthcare Sales & Marketing Network) - Patients worldwide with advanced lung cancer can expect longer survival according to new data from the TRUST study presented at the 12th World Conference on Lung Cancer (WCLC) in Seoul, Korea. These new worldwide observations show that patients suffering from non-small cell lung cancer (NSCLC) and treated with Tarceva (erlotinib) in routine clinical practice are experiencing longer life. The results from TRUST reinforce the benefits that patients experienced in the landmark BR.21 study that earned Tarceva its approval in over 80 countries. non-small cell lung cancer is the most common form of lung cancer suffered by over one million people worldwide.

In BR.21, 31% of patients receiving Tarceva were alive at one year compared to 22% in the placebo arm and patients experienced a 42.5% improvement (6.7 months vs. 4.7 months) in length of survival. In TRUST, data from 6,181 patients reported a median overall survival of 7.5 months. Data on the remaining patients are still being analyzed and will be announced at a later date.

"The increased survival time in patients from TRUST reinforces what we are seeing in our clinical practices," said Professor Tony Mok of the Department of Clinical Oncology, Chinese University of Hong Kong. "These new data further underscore the drug's potential across a broad range of lung cancer patients and show that Tarceva enables patients to spend more quality time with their families and loved ones."

TRUST is the largest and longest ongoing study ever conducted of Tarceva. It includes almost 12,000 patients with advanced NSCLC in over 59 countries in Asia, Europe and the Americas.

Over 182,000 patients worldwide have been treated with Tarceva since it was launched three years ago. These latest data reinforce that Tarceva is fulfilling its promise of offering longer survival and better quality of life to a broad range of patients - men, women, smokers, non-smokers and people from a wide range of ethnic groups - with NSCLC, one of the world's most deadly forms of cancer.

"TRUST demonstrates that even in routine clinical practice Tarceva has comparable efficacy to BR.21," said Dr. Ulrich Gatzemeier, an investigator for TRUST at the Department of Thoracic Oncology, Hospital Grosshansdorf, Hamburg, Germany. "This is a great step forward in the treatment of lung cancer, and one which will offer hope to many patients and families affected by this disease."

Roche's ongoing commitment to patients

Tarceva is currently being evaluated in an extensive clinical development program on earlier stages of NSCLC by a global alliance comprising OSI Pharmaceuticals, Genentech and Roche. Under this program, almost 20 clinical studies are being conducted with Tarceva to discover new ways to further increase its life-extending benefits for patients with lung and other types of cancer. Additionally, Tarceva is being studied in combination with Avastin in NSCLC and in a wide variety of other solid tumour types.

"TRUST is just one of the many major clinical trials supported by Roche currently underway to help identify those patients who can benefit the most from treatment with Tarceva," said William M. Burns, CEO of the Pharmaceuticals Division at Roche. "Our focus is to improve survival rates and quality of life for people suffering from all types of cancer."

For further information and all the latest news on Tarceva and lung cancer please visit

Notes to Editors


TRUST, the largest and longest ongoing study of Tarceva in lung cancer worldwide, involves nearly 12,000 NSCLC patients from 59 countries across Asia, the Middle East, Europe and the Americas. It is a multi-center, global, open-label study of Tarceva in lung cancer patients for the second- or third-line treatment of advanced non-small cell lung cancer (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. Since TRUST started in 2004, 93% of the participating countries received approval of Tarceva as monotherapy for patients with advanced NSCLC.
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 to chemotherapy by specifically targeting tumour cells, and avoids 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 three years ago, Tarceva has been used to treat more than 182,000 patients and has been approved in over 80 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 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 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. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invests approximately 7 billion Swiss francs a year in R&D. Worldwide, the Group employs about 75,000 people. Additional information is available on the Internet at

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This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as 'believes', 'expects', 'anticipates', 'projects', 'intends', 'should', 'seeks', 'estimates', 'future' or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, among others: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche's earnings or earnings per share for any current or future period will necessarily match or exceed the historical published earnings or earnings per share of Roche.

End Notes:

- IARC. GLOBOCAN 2002. Cancer incidence, Mortality and Prevalence Worldwide.

- F. Shepherd, J. Rodrigues Pereira, T. Ciuleanu. 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 JMed 2005;353:123-32.

Source: Roche Group

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