Drug Tarceva improves survival chance for patients with advanced lung cancer

Roche OSI Pharmaceuticals and Genentech today announced that their investigational drug Tarceva(TM) (erlotinib) achieved a significant 42.5% improvement in median survival compared to placebo in patients with advanced non-small cell lung cancer (NSCLC). The results of the BR.21 Phase III study were highlighted today for the first time at a press briefing organised by the American Society of Clinical Oncology (ASCO). Non-small cell lung cancer is the most common form of the disease and accounts for almost 80 percent of all lung cancer - it has a very high mortality rate and few treatment options exist.

The study, conducted by the Clinical Trials Group of the National Cancer Institute of Canada Clinical Trials Group based at Queen's University, Ontario, in collaboration with OSI Pharmaceuticals, involved 731 patients with advanced NSCLC who had failed to respond to first or second line chemotherapy. The study met its primary endpoint in that patients receiving Tarceva lived longer than those in the placebo arm (6.7 months vs 4.7 months)(1), and also met all of its secondary endpoints including improving time to symptomatic deterioration, progression-free survival and response rate. In addition, analysis of the results showed a treatment benefit in all subsets of patients examined.

"These results represent an important medical advance in the treatment of advanced lung cancer patients," stated Study Chair, Frances A. Shepherd, M.D., FRCPC, Scott Taylor Chair in Lung Cancer Research at the Princess Margaret Hospital, Professor of Medicine at the University of Toronto. "The outcome of the study is particularly noteworthy considering the broad spectrum of advanced lung cancer patients enrolled in the study. The observations concerning symptoms are also particularly meaningful to these patients."

"Tarceva is the first and only EGFR-targeted anticancer treatment ever to have shown significant survival prolongation in any tumour type", said Dr. Stefan Manth, Head of Roche Oncology. "Based on these study results, our goal is now to work with regulatory authorities around the world to make this medicine available to patients with NSCLC as soon as possible."

About the Study

This trial of Tarceva(TM) met the pre-determined primary study endpoint of improvement in overall survival and demonstrated significant effects in all secondary endpoints including, time to symptom deterioration, progression-free survival and response rate. A total of 731 patients were enrolled in BR.21, a randomized, international, double-blind controlled study comparing the use of 150mg/day Tarceva(TM) versus placebo for the treatment of patients with advanced NSCLC following failure of first or second-line chemotherapy. The study randomized patients with a 2:1 ratio in favour of Tarceva(TM) to receive either Tarceva(TM) or placebo.

Patients receiving Tarceva(TM) had a median survival of 6.7 months compared to 4.7 months in patients who received placebo (a 42.5 percent improvement). A hazard ratio of 0.72 and a p-value of 0.001 were determined for comparisons of overall survival (a hazard ratio (HR) of less than one indicates a reduction in the risk of death and a p-value of less than 0.05 indicates statistical significance). In addition, 31 percent of patients receiving Tarceva(TM) in the study were alive at one year versus 22 percent in the placebo arm (a 41 percent improvement). Statistically significant improvements in time to symptom deterioration were observed for key lung cancer symptoms of cough, pain, and dyspnea. The objective response rate in patients treated with Tarceva(TM) was 9 percent versus less than 1 percent in the placebo arm.

Approximately 50 percent of the patients in the study had previously received one prior regimen while the remainder had received two prior regimens. In addition, the study enrolled a relatively large proportion of patients with poor performance status (PS2: 25% and PS3: 9%). Despite these unfavourable pre-treatment characteristics treatment benefit was documented in the majority of patients.

About Tarceva

Tarceva is an investigational small molecule designed to target the human epidermal growth factor receptor (HER1) pathway, which is one of the factors critical to cell growth in many cancers. HER1, also known as EGFR, is a key component of the HER signalling pathway, which plays a role in the formation and growth of numerous cancers. Tarceva is designed to inhibit the tyrosine kinase activity of the HER1 signalling pathway inside the cell, which may block tumour cell growth. Results of a Phase III trial of Tarceva in pancreatic cancer are expected during the second half of 2004. Early-stage trials of Tarceva are being conducted in other solid tumours such as ovarian, colorectal, head and neck, renal cell carcinoma, glioma and gastrointestinal cancers. Tarceva(TM) was discovered by OSI Pharmaceuticals and is being developed by a global alliance of Roche, OSI Pharmaceuticals and Genentech.

About Non-Small Cell Lung Cancer

According to the World Health Organization, there are more than 1.2 million cases worldwide of lung and bronchial cancer each year, causing approximately 1.1 million deaths annually. Non-small cell lung cancer is the most common form of the disease and accounts for almost 80 percent of all lung cancer.

Roche in Oncology

Within the last five years the Roche Group has become the world's leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed products with survival benefit: Herceptin, MabThera, Xeloda and Avastin which has been launched by Genentech in the US recently, treat a range of malignancies such as breast cancer, non-Hodgkin's lymphoma and colorectal cancer. Other key products include NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma). CERA is the most recent demonstration of the commitment to anaemia management. Roche's cancer medicines generated sales of more than 6 billion Swiss francs in 2003.

In a recent phase III study Tarceva met its primary endpoint of improving overall survival in patients with non-small cell lung cancer.

Roche is developing new tests, which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumor markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.

Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).

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

Further information: - www.roche.com - www.gene.com - www.osip.com

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