OSI Pharmaceuticals, Inc., Genentech, Inc., and Roche 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 Food and Drug Administration (FDA) to complete the New Drug Application (NDA) for Tarceva during the summer.

This international study, which was sponsored by OSI, was conducted by the National Cancer Institute of Canada Clinical Trials Group at Queens University in collaboration with OSI. Results of this Phase III trial will be presented at the upcoming 2004 Annual Meeting of the American Society of Clinical Oncology (ASCO) in New Orleans, Louisiana from June 5 to 8.

"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 Colin Goddard, Ph.D., 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."

"The results of this controlled trial of Tarceva represent a significant advancement in treating patients with relapsed non-small cell lung cancer because Tarceva was shown to both extend life and provide symptomatic improvement," said 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 and principal investigator of the trial.

"Approximately 173,000 Americans will be diagnosed with lung cancer this year," said Hal Barron, M.D., 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."

The multi-center, randomized, controlled Phase III study evaluated Tarceva at 150 mg/day in patients with stage IIIB/IV recurrent NSCLC. The study participants must have received at least one, but no more than two prior chemotherapy regimens. The study randomized patients to receive either Tarceva or placebo. This was an international study with sites in Canada, Argentina, Australia, Brazil, Chile, Germany, Greece, Hong Kong, Israel, Mexico, New Zealand, Romania, Singapore, South Africa, Sweden, Thailand and the United States.

A preliminary analysis of safety data showed that the toxicities reported were as expected in patients receiving Tarceva compared to those receiving placebo. In line with previous clinical studies, events that occurred more often with patients treated with Tarceva included mainly mild to moderate diarrhea and rash.

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 tumor 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 tumors, such as ovarian, colorectal, head and neck, renal cell carcinoma, glioma and gastrointestinal cancers.

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. 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 United States, and is responsible for nearly 30 per cent of cancer deaths in the country. Non-small cell lung cancer is the most common form of the disease and accounts for almost 80 per cent of all lung cancer.