Genentech, Inc. and OSI Pharmaceuticals have presented additional data from a randomized Phase III clinical trial of Tarceva (erlotinib) in advanced pancreatic cancer at the 41st Annual Meeting of the American Society of Clinical Oncology (ASCO). Tarceva is the first drug to significantly improve survival in a Phase III trial when added to gemcitabine chemotherapy in first-line pancreatic cancer compared to gemcitabine alone.

"These ongoing trials reinforce our belief in the potential application of Tarceva in a variety of cancers," said Gabe Leung, president of (OSI) Oncology at OSI Pharmaceuticals. "Based on these data OSI recently submitted to the FDA a supplemental New Drug Application for Tarceva in pancreatic cancer and will be working closely with the FDA through the review process," he added.

"The improvement in survival demonstrated by Tarceva in second- and third-line non-small cell lung cancer as monotherapy and in first-line pancreatic cancer in combination with gemcitabine, underscores our commitment to explore the use of Tarceva in multiple cancers, with the hope of bringing new treatment options to patients," said Hal Barron, Genentech's senior vice president, development and chief medical officer.

A Phase III randomized study of Tarceva in combination with gemcitabine met its primary endpoint by demonstrating a statistically significant 23.5 per cent improvement in overall survival (or a hazard ratio of 0.81, which can also be referred to as a 19 percent reduction in the risk of death), the study's primary efficacy endpoint, when compared to patients receiving gemcitabine plus placebo.

The international study was a multi-centre, double-blind, placebo-controlled Phase III trial evaluating Tarceva in patients with locally advanced or metastatic pancreatic cancer. The study randomized 569 patients to receive either gemcitabine plus concurrent Tarceva or gemcitabine plus placebo.

In addition to the improvement in overall survival, 24 per cent of patients receiving Tarceva plus gemcitabine were alive after one year compared to 17 per cent of patients receiving gemcitabine plus placebo, a 41 per cent increase in one-year survival.

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 non-small cell lung cancer (NSCLC) and other solid tumours.