Genentech, Inc and OSI Pharmaceuticals, Inc announced that a randomized phase-III study (BeTa Lung) evaluating Avastin (bevacizumab) in combination with Tarceva (erlotinib) in patients with advanced non-small cell lung cancer (NSCLC) whose disease had progressed following platinum-based chemotherapy did not meet its primary endpoint of improving overall survival compared to Tarceva in combination with placebo. However, there was clear evidence of clinical activity with improvements in the secondary endpoints of progression-free survival (PFS) and response rate when Avastin was added to Tarceva compared to Tarceva alone in this study.

Median survival was similar in both arms of BeTa Lung. No new or unexpected safety signals for either Avastin or Tarceva were observed in the study, and adverse events were consistent with those observed in previous NSCLC clinical trials evaluating the agents. The companies are further analyzing the study results and will submit the data for presentation at the 2008 Chicago Multidisciplinary Symposium in Thoracic Oncology in Chicago, Ill., November 13-15.

"We are disappointed this study did not show an improvement in survival for patients with advanced lung cancer who have a poor prognosis and a disease that is extremely difficult to treat. We are, however, encouraged to see the combination of Avastin and Tarceva had clear evidence of biological activity, and will fully analyze the data so that we can apply the insights to our ongoing lung cancer research," said Hal Barron, Genentech's senior vice president, Development and chief medical officer. "The results of this study do not affect Avastin or Tarceva's approved indications in advanced non-small cell lung cancer."

Avastin is currently approved as first-line treatment in combination with carboplatin and paclitaxel chemotherapy for patients with locally advanced, non-squamous, NSCLC based on a 25 per cent improvement in overall survival compared to chemotherapy alone (hazard ratio 0.80).

Tarceva is currently approved as a treatment for patients with advanced NSCLC who have progressed following treatment with at least one prior chemotherapy regimen, based on a 37 per cent improvement in overall survival compared to placebo (hazard ratio 0.73).

"The data from this study continue to support the role of Tarceva as an important treatment option for advanced lung cancer patients," said Gabriel Leung, president, OSI Oncology. "Median survival in the Tarceva and placebo group in this second-line study was 9.2 months. As expected, this exceeded the median survival of 6.7 months seen in the Tarceva registration study, BR.21, that included patients treated in both the second- and third-line settings. We look forward to results of Saturn, a phase-III trial evaluating single-agent Tarceva as a first-line maintenance therapy in NSCLC patients whose disease has not progressed following treatment with chemotherapy."

A second study (ATLAS) is evaluating the combination of Avastin and Tarceva as a potential first-line maintenance therapy for advanced non-small cell lung cancer patients whose disease has not progressed following initial treatment with Avastin in combination with chemotherapy. Results are expected in the first half of 2009.

Avastin is a biologic antibody designed to specifically inhibit the vascular endothelial growth factor (VEGF) protein that plays an important role in the development and maintenance of blood vessels, a process known as angiogenesis.

Tarceva is a small molecule designed to target the EGFR pathway, which is one of the factors critical to cell growth in NSCLC and pancreatic cancers.

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines for patients with significant unmet medical needs.

OSI Pharmaceuticals is committed to 'shaping medicine and changing lives' by discovering, developing and commercializing high-quality and novel pharmaceutical products designed to extend life and/or improve the quality of life for patients with cancer and diabetes/obesity.