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R&D In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Avastin/Tarceva combination lung cancer trial misses endpoint: The combination of Avastin (bevacizumab) and Tarceva (erlotinib) failed to meet its primary endpoint - median overall survival in patients with advanced non-small cell lung cancer whose disease progressed following platinum-based chemotherapy - in the Phase III BETA Lung trial, Genentech and OSI Pharmaceuticals announce Oct. 5. OSI and Genentech partner on Tarceva, a small molecule that targets the epidermal growth factor receptor pathway; Genentech and Roche market the blockbuster vascular endothelial growth factor inhibitor Avastin. While OSI and Genentech reserved many of the trial details for presentation to the Chicago Multidisciplinary Symposium in Thoracic Oncology next month, the firms noted that the combo improved progression-free survival and response rate in the 636-patient second-line NSCLC study. The companies also said median survival was similar in both arms of the trial. Surprisingly, the BETA control arm of Tarceva plus placebo produced a median survival of 9.2 months, exceeding the 6.7 months seen in Tarceva registration trials, which included both second- and third-line NSCLC patients. The companies expect data from another Avastin/Tarceva combination trial, the Phase III ATLAS study, in the first half of 2009; ATLAS is testing the pairing in first-line maintenance therapy of NSCLC patients who have responded to first-line Avastin plus chemotherapy
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