New cancer drug Tarceva - a breakthrough with significant survival benefit in patients with advanced lung cancer

OSI Pharmaceuticals, Inc., Genentech, Inc., and Roche today 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."

About the Study

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.