Updated overall survival (OS) results for BRF113220, a phase I-II study of dabrafenib alone versus combined dabrafenib and trametinib in patients with BRAF V600 metastatic melanoma (MM).

9036 Background: This Phase I—II study evaluated the safety and efficacy of the combination of dabrafenib and trametinib (the combination) compared with dabrafenib alone (monotherapy) in patients (pts) with BRAF V600 MM. Methods: BRAF V600E/K MM pts naive to BRAF and MEK inhibitors were enrolled. Part B (Ph I, n = 77 BRAFi-naive) pts enrolled into escalating dose (mg) cohorts of dabrafenib twice daily (BID)/trametinib once daily (QD) as follows: 75/1, 150/1, 150/1.5 and 150/2. Part C (Ph II, n=162) pts were randomized 1:1:1 to dabrafenib 150 mg monotherapy, 150/1 and 150/2. Crossover from monotherapy to 150/2 combination was allowed post-progression of disease. Primary endpoints were progression-free survival, response rate, duration of response, and safety; secondary endpoints were OS and pharmacokinetics. Results: Previously reported landmark 2-year OS results for pts in Parts B and C with median follow-up of 35 and 34 mo is presented in Table 1.In Part C, median OS rate for 150/2 combination pts was 25...