Tarceva erlotinib: Phase III data

The open-label, Chinese Phase III OPTIMAL trial in 165 chemotherapy-naïve NSCLC patients with activating EGFR mutations showed that 150 mg once-daily oral Tarceva met the primary endpoint of significantly improving PFS vs. Gemzar gemcitabine plus carboplatin chemotherapy (13.1 vs. 4.6 months, p<0.0001). Additionally, 56% of patients treated with Tarceva were alive and progression free at 1 year vs. 1.7% for Gemzar plus carboplatin. Tarceva also significantly improved ORR vs. chemotherapy (83% vs. 36%, p<0.0001). OS 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. ...