Tarceva erlotinib: Phase III data

Additional data from the open-label, European Phase III EURTAC trial in 153 advanced NSCLC patients with EGFR activating mutations showed that once-daily 150 mg Tarceva as first-line treatment significantly improved PFS vs. platinum-based chemotherapy (9.4 months vs. 5.2 months, p<0.0001). On secondary endpoints, Tarceva produced a significantly higher response rate compared to chemotherapy (54.5% vs. 10.5%, p<0.0001) but did not show a significant benefit in median overall survival (22.9 months vs. 18.8 months, p=0.42). The most common adverse events in patients receiving Tarceva were diarrhea, asthenia and rash. Data will be presented at the American Society of Clinical Oncology meeting in Chicago in June.

In January, an independent DMC recommended the trial be stopped early after an interim analysis showed Tarceva had met the primary endpoint of significantly improving PFS vs. chemotherapy (see BioCentury, Jan. 31). At the time, Roche's Genentech Inc. unit and OSI Pharmaceuticals Inc., now part of Astellas, said they planned to discuss potential updates to Tarceva's label with FDA. Last June, Roche submitted a regulatory application to the European Medicines Agency (EMA) to extend the label of Tarceva to include first-line treatment of patients with advanced NSCLC whose tumors harbor EGFR activating mutations. ...