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news.Genentech and OSI Pharmaceuticals have announced that a randomized Phase III study evaluating Avastin in combination with Tarceva in patients with advanced non-small cell lung cancer 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.
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However, there was clear evidence of clinical activity with improvements in the secondary endpoints of progression-free survival and response rate when Avastin was added to Tarceva compared to Tarceva alone in this study, the two companies said.
Median survival was similar in both arms of the Phase III study (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 non-small cell lung cancer (NSCLC) clinical trials evaluating the agents.
A second study (Atlas) is evaluating the combination of Avastin and Tarceva as a potential first-line maintenance therapy for advanced NSCLC patients whose disease has not progressed following initial treatment with Avastin in combination with chemotherapy. Results are expected in the first half of 2009.
Gabriel Leung, president of OSI oncology, said: “The data from this study continue to support the role of Tarceva as an important treatment option for advanced lung cancer patients. 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.”