Dabrafenib: Additional Phase III data

Additional data from the open-label, international Phase III BREAK-3 (BRF113683) trial in 250 patients with previously untreated unresectable BRAF V600E mutation-positive metastatic stage III/IV melanoma showed that twice-daily 150 mg oral Tafinlar led to a median OS, a secondary endpoint, of 20 months vs. 15.6 months for patients randomized to receive IV dacarbazine every 3 weeks (p=not significant). GlaxoSmithKline said that 59% of patients in the dacarbazine arm whose disease progressed subsequently crossed over to receive Tafinlar and were included in the results for the control arm. At 2 years, 45% of patients treated with Tafinlar only were alive vs. 32% of patients who began treatment with dacarbazine. Data were presented at the European Society for Medical Oncology meeting in Madrid. A final OS analysis is expected in 2016. GSK previously reported that Tafinlar met the primary endpoint of improving median PFS vs. dacarbazine (see BioCentury, June 11, 2012). ...