Roche announces topline outcomes for Avastin-Tarceva combination study in advanced lung cancer

Roche today announced topline results from the phase III BeTa Lung study investigating the addition of Avastin (bevacizumab) to Tarceva (erlotinib) compared with Tarceva alone for the second-line treatment of patients with advanced non-small cell lung cancer (NSCLC), the most common form of lung cancer. The primary endpoint, a significant increase in overall survival with the Avastin- Tarceva combination compared with Tarceva alone, was not met with the median survival being similar in both arms of the study.

Further analyses, including post-progression therapy, are being conducted to explore the potential impact on the overall survival endpoint. However, the study showed improvements in secondary efficacy endpoints. There was clear evidence of an increase in time patients lived without their disease getting worse (progression-free survival) as well as of response rate when Avastin was added to Tarceva compared to Tarceva alone. No new safety signals for Avastin or Tarceva were reported, and the adverse events were similar to those observed in previous NSCLC clinical trials. Roche is further analysing the study results and the data will be submitted for presentation at the 2008 Chicago Multidisciplinary Symposium in Thoracic Oncology in Chicago, III., November 13-15.

“Advanced lung cancer has a very poor prognosis and is an extremely difficult-to-treat disease. We are encouraged to see that the combination of Avastin and Tarceva showed evidence of clinical activity for the patients,’’ said William M. Burns, CEO of Roche’s Pharmaceuticals Division. “The results of the study do not affect the approved indications of Avastin or Tarceva in advanced lung cancer. Roche remains committed to the development of innovative treatments for NSCLC.’’
Both Avastin and Tarceva are already available for the treatment of patients with advanced NSCLC in the US and Europe. Avastin used first-line in combination with platinum-based chemotherapy is proven to deliver the longest survival times for previously untreated patients while Tarceva in second-line was the first targeted therapy to significantly improve survival in previously treated patients. The evidence of clinical activity with the combination of Avastin and Tarceva in the BeTa Lung trial is encouraging for the ongoing trials evaluating this chemotherapy-free combination in the first-line setting. A second study (ATLAS) is evaluating the combination of Avastin and Tarceva as first-line maintenance therapy for advanced 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.