Tafinlar dabrafenib: Interim Phase II data

Interim data from 13 evaluable NSCLC patients with V600 BRAF mutations who failed >=1 line of chemotherapy in the 2-stage, open-label, international Phase II BRF113928 trial showed that twice-daily 150 mg Tafinlar led to an ORR of 54%, including 5 confirmed partial responses, 2 unconfirmed partial responses and 1 case of stable disease. There was 1 discontinuation due to a serious adverse event of hypersensitivity reaction. The most common adverse events reported were decreased appetite, fatigue, asthenia, dyspnea and nausea. Grade 4 hemorrhage occurred in 1 patient and 5 patients had a grade 3 adverse event. GlaxoSmithKline said the trial met the minimum response rate of >=3 responses in the first 20 patients to continue to the second stage of the trial. The trial plans to enroll about 40 patients. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...