Roche, Genentech and OSI Pharmaceuticals Inc announced that the primary endpoint of improving overall survival was not met in two first-line randomised controlled Phase III studies of Tarceva (erlotinib) plus standard chemotherapy in advanced non-small cell lung cancer patients.

In light of data of comparable studies with a competitive product, the results of this study are not unexpected. The outcome of the two studies does not affect the financial projections communicated earlier by Roche.

"Further work is needed to provide more insight into the role of EGFR inhibitors combined with chemotherapy in this setting," said William M. Burns, Head of Roche Pharmaceuticals. "In order to assess the therapeutic potential of EGFR inhibition, we will continue to analyse the data for potential subsets of patients who are more likely to benefit from treatment with Tarceva in combination with chemotherapy. We will continue our clinical development programme and believe Tarceva may have utility in treating a variety of other cancers."

The two studies are part of an ongoing comprehensive clinical development programme, which includes a Phase III study of Tarceva as a single-agent in a second/third-line setting, a Phase II study of Tarceva as a single-agent in bronchioloavelar cell carcinoma (BAC) and a Phase I/II trial of Tarceva in combination with Avastin. In a phase II study Tarceva has shown effectiveness in brain cancer (glioma).

Tarceva is a new form of anti-cancer treatment currently being tested in a variety of tumour types. It is a small molecule that works by blocking the activity of an enzyme called epidermal growth factor receptor (EGFR) tyrosine kinase, which helps communicate information within the cancer cell. EGFR, also known as HER1, is found on the surface of many tumour cells and may be involved in the growth and virulence of those cells. Tarceva is designed to inhibit the tyrosine kinase activity of the EGFR signaling pathway inside the cell, which may block tumour growth.

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. 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 percent of cancer deaths in the country. Non-small cell lung cancer is the most common form of the disease and accounts for almost 80 percent of all lung cancers.