BACKGROUND: Approximately 50% of @entity320 harbor activating (V600) mutations in the @entity563 - @entity1889 protein kinase B-RAF ( @entity817 ). The oral @entity817 inhibitor @entity5457 ( @entity5457 ) frequently produced @entity5 regressions in @entity1 with @entity817 V600-mutant metastatic @entity320 in a phase 1 trial and improved overall survival in a phase 3 trial. METHODS: We designed a multicenter phase 2 trial of @entity5457 in @entity1 with previously treated @entity817 V600-mutant metastatic @entity320 to investigate the efficacy of @entity5457 with respect to overall response rate (percentage of treated @entity1 with a @entity5 response), duration of response, and overall survival. The primary end point was the overall response rate as ascertained by the independent review committee; overall survival was a secondary end point. RESULTS: A total of 132 @entity1 had a median follow-up of 12.9 months (range, 0.6 to 20.1). The confirmed overall response rate was 53% (95% confidence interval [CI], 44 to 62; 6% with a complete response and 47% with a partial response), the median duration of response was 6.7 months (95% CI, 5.6 to 8.6), and the median progression-free survival was 6.8 months (95% CI, 5.6 to 8.1). Primary progression was observed in only 14% of @entity1 . Some @entity1 had a response after receiving @entity5457 for more than 6 months. The median overall survival was 15.9 months (95% CI, 11.6 to 18.3). The most common adverse events were grade 1 or 2 @entity4841 , @entity1910 , photosensitivity, @entity1295 , and @entity1665 . @entity957 (the majority, keratoacanthoma type) were diagnosed in 26% of @entity1 . CONCLUSIONS: @entity5457 induces clinical responses in more than half of @entity1 with previously treated @entity817 V600-mutant metastatic @entity320 . In this study with a long follow-up, the median overall survival was approximately 16 months. (Funded by Hoffmann-La Roche; ClinicalTrials.gov number, NCT00949702.).

Survival in @entity817 V600-mutant advanced @entity320 treated with XXXX .

@entity1 :: ('9606', 'Species') :: ['patients'] @entity1665 :: ('MESH:D000505', 'Disease') :: ['alopecia'] @entity1910 :: ('MESH:D005076', 'Disease') :: ['rash'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumor'] @entity957 :: ('MESH:D002294', 'Disease') :: ['Cutaneous squamous-cell carcinomas'] @entity1295 :: ('MESH:D005221', 'Disease') :: ['fatigue'] @entity817 :: ('673', 'Gene') :: ['BRAF'] @entity563 :: ('CHEBI:17822', 'Chemical') :: ['serine'] @entity4841 :: ('MESH:D018771', 'Disease') :: ['arthralgia'] @entity1889 :: ('CHEBI:26986', 'Chemical') :: ['threonine'] @entity320 :: ('MESH:D008545', 'Disease') :: ['melanoma', 'melanomas'] @entity5457 :: ('MESH:C551177', 'Chemical') :: ['PLX4032', 'vemurafenib', 'Vemurafenib']
@entity5457 :: (MESH:C551177,Chemical) :: ['vemurafenib']
