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Practice-changing phase III data in melanoma patients cause excitement at a Presidential Symposium

September 12, 2017

Karl Lewis, MD
​Late-Breaking Abstract presentations of phase III trial data in yesterday’s Presidential Symposium gave exciting new insights into the future of treatment for resected, high-risk melanoma. 
One of two studies investigating adjuvant BRAF inhibitor therapy for patients with BRAF V600 mutation-positive melanoma, the COMBI-AD trial, reported that the combination of dabrafenib plus trametinib significantly doubled relapse-free survival (RFS)—the primary endpoint—and improved a number of other endpoints, such as overall survival (OS), distant metastasis-free survival and freedom from relapse, compared with placebo in 870 patients with stage III disease (Abstract LBA6_PR).1 In the placebo-controlled BRIM8 trial, disease-free survival benefits with vemurafenib were substantial and significant for stage IIC–IIIB melanoma, but did not reach significance for stage IIIC disease (Abstract LBA7_PR). 

During the same session, the CheckMate 238 trial demonstrated 
that adjuvant nivolumab was more effective than ipilimumab among 906 patients with stage III/IV melanoma after complete resection (Abstract LBA8_PR).2 The trial was stopped early due to clear evidence of benefit with nivolumab, which not only significantly improved RFS (hazard ratio [HR] 0.65; p<0.0001), but was far better tolerated.