For Healthcare Professionals Outside the US
Crossover was prohibited; however, at the time of the first OS analysis, the protocol was amended so that patients who were initially randomized to vemurafenib could cross over to receive Tafinlar + Mekinist because of the clear survival benefit.
Crossover was not allowed during the course of the study in order to preserve the integrity of the OS endpoint. However, after the 2-year OS data cutoff, crossover was subsequently allowed and may confound future OS analyses.
BID, twice daily; cuSCC, cutaneous squamous cell carcinoma; DOR, duration of response; ECOG, Eastern Cooperative Oncology Group; ERK, extracellular signal–regulated kinase; MEK, mitogen-activated protein kinase/extracellular signal–regulated kinase; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; QD, once daily; RECIST, Response Evaluation Criteria In Solid Tumors.
References: 1. Robert C, Karaszewska B, Schachter J, et al. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015;372(1):30-39. 2. Long GV, Stroyakovskiy D, Gogas H, et al. Dabrafenib and trametinib versus dabrafenib and placebo for Val600 BRAF-mutant melanoma: a multicentre, double-blind, phase 3 randomised controlled trial. Lancet. 2015;386(9992):444-451. 3. Flaherty KT, Infante JR, Daud A, et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N Engl J Med. 2012;367(18):1694-1703.