BASEL, SwitzerlandRoche has announced that the international phase III Avastin in Lung study (AVAiL, BO17704) met its primary endpoint of improving progression-free survival in patients with previously untreated advanced non-squamous-cell, non-small-cell lung cancer (NSCLC). The Food and Drug Administration (FDA) approved Avastin (bevacizumab) for the treatment of NSCLC in October 2006, and it is being considered for approval in Europe.
The trial included more than 1,000 patients randomized to receive gemcitabine(Drug information on gemcitabine) (Gemzar)/cisplatin chemotherapy with or without the antiangiogenesis agent bevacizumab(Drug information on bevacizumab) given in a schedule of either 7.5 mg/kg or 15 mg/kg every 3 weeks. Although the study was not designed to compare the bevacizumab doses, the two doses showed a similar treatment effect in progression-free survival. There were no new safety signals associated with the use of bevacizumab at either dose in this clinical setting, the company said.
The chemotherapy used in the AVAiL trial was different from the platinum-based regimen used in the pivotal E4599 trial (carboplatin and paclitaxel(Drug information on paclitaxel)). E4599 showed a 27% improvement in survival with the addition of bevacizumab to the chemotherapy regimen in patients with non-squamous-cell, advanced NSCLC.
In a press release, Roche and Genentech said that the benefit and relative safety of each study arm will be presented at an upcoming medical meeting. "We look forward to sharing the findings with health authorities in Europe and working with them to make Avastin available to patients with advanced lung cancer as soon as possible," said William M. Burns, CEO of Roche Pharmaceuticals.