Genentech, Inc, announced that a phase III study (ATLAS) of erlotinib (Tarceva) in combination with bevacizumab (Avastin) as maintenance therapy following initial treatment with Avastin plus chemotherapy in advanced non–small-cell lung cancer (NSCLC) met its primary endpoint. The study was stopped early on the recommendation of an independent data safety monitoring board after a preplanned interim analysis showed that combining erlotinib and bevacizumab significantly extended the time patients lived without their disease advancing, as defined by progression-free survival (PFS), compared to bevacizumab plus placebo. A preliminary safety analysis showed adverse events were consistent with previous bevacizumab or erlotinib studies, as well as trials evaluating the two drugs together, and no new safety signals were observed. Data will be submitted for presentation at a future medical meeting.
“This is the second study to show that people with lung cancer who took the daily pill Tarceva following initial treatment lived longer without their cancer getting worse. We plan to discuss these data with the FDA to determine next steps,” said Hal Barron, MD, Genentech’s senior vice president, Development and chief medical officer. “Tumors use different pathways to grow and these results showed that combining medicines targeting two of these pathways instead of one delayed disease progression.”
An earlier study, SATURN, showed erlotinib delayed disease progression when given as a single agent immediately following treatment with chemotherapy, compared to placebo. In ATLAS, patients were initially treated with bevacizumab plus chemotherapy followed by the addition of erlotinib to bevacizumab in the maintenance phase.
Bevacizumab is currently approved as first-line treatment in combination with carboplatin and paclitaxel chemotherapy for patients with locally advanced, non-squamous NSCLC, and erlotinib is currently approved as a treatment for patients with advanced NSCLC who have progressed following treatment with at least one prior chemotherapy regimen. Both therapies have been shown to improve overall survival in these indications.