Tarceva extends survival of patients with relapsed NSCLC

OSI Pharmaceuticals, Genentech and Roche have announced that a Phase III study of Tarceva (erlotinib HCl), an investigational HER1/EGFR-inhibitor agent in previously treated patients with non-small cell lung cancer (NSCLC), met its primary endpoint of improving overall survival, with patients receiving Tarceva living longer than those in the placebo arm of the study.

The trial also met secondary endpoints including improving time to symptomatic deterioration, progression-free survival and response rate. OSI will work with the FDA to complete the New Drug Application (NDA) for Tarceva during the summer.

'We are extremely pleased with the results of this trial. This is the first controlled Phase III study of a HER1/EGFR-targeted agent which has shown an improvement in survival in any disease setting,' said Dr Colin Goddard, chief executive officer of OSI Pharmaceuticals. 'Because Tarceva was granted Fast Track designation from the FDA, we will work with the agency to make Tarceva available as quickly as possible to patients.'

'Approximately 173,000 Americans will be diagnosed with lung cancer this year,' said Dr Hal Barron, Genentech's senior vice president of development and chief medical officer. 'We are excited that pending FDA approval, patients with relapsed non-small cell lung cancer will have a new treatment alternative that has clinically demonstrated the ability to prolong survival.'

About Tarceva

Tarceva is a small molecule designed to target the human epidermal growth factor receptor 1 (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 signaling 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 signaling pathway inside the cell, which may block tumour cell growth. Results of a Phase III trial of Tarceva in pancreatic cancer are expected in 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.

About Non-Small Cell Lung Cancer

According to the World Health Organisation, there are more than 1.2m cases worldwide of lung and bronchial cancer each year, causing approximately 1.1m deaths annually. It is estimated that more than 173,000 people will be diagnosed with lung cancer in the United States in 2004. According to the National Cancer Institute, lung cancer is the single largest cause of cancer deaths in the US, and is responsible for nearly 30% of cancer deaths in the country. Non-small cell lung cancer is the most common form of the disease and accounts for almost 80% of all lung cancer.