ARTICLE | Clinical News

Tarceva OPTIMAL in first-line NSCLC

October 12, 2010 12:53 AM UTC

Roche (SIX:ROG; OTCQX:RHHBY) said once-daily oral Tarceva erlotinib met the primary endpoint of significantly improving progression-free survival vs. Gemzar gemcitabine plus carboplatin chemotherapy in the Phase III OPTIMAL trial for first-line treatment of advanced non-small cell lung cancer (NSCLC) (13.1 vs. 4.6 months, p<0.0001). The open-label, Chinese trial enrolled 165 chemotherapy-naive NSCLC patients with activating EGFR mutations. Overall survival data are not yet mature. The incidence of serious adverse events was lower in the Tarceva arm compared with chemotherapy. Data were presented at the European Society for Medical Oncology meeting in Milan. Roche said the European Medicines Agency (EMA) is reviewing an application to extend Tarceva's label to include first-line monotherapy in advanced NSCLC patients with activating EGFR mutations. ...