Single-center phase 2 trial of neoadjuvant dabrafenib and trametinib for stage III melanoma: five-year follow-up of NeoCombi

The phase 2 NeoCombi trial, at Melanoma Institute Australia (Sydney) included patients with stage III BRAF V600E/K mutant melanoma, who received neoadjuvant dabrafenib plus trametinib for 12 weeks, followed by surgery and another 40 weeks of adjuvant dabrafenib plus trametinib. The neoadjuvant treatment resulted in high rates of pathological response (pCR). Five-year follow-up results of the trial have now been published. Recurrence occurred in 60% of patients, including 57% with first recurrence in locoregional sites and 43% with recurrence at distant sites. At five years, recurrence-free survival rate was 40%, distant metastasis-free survival rate was 57%, and overall survival rate was 80%. Five-year recurrence rates were not significantly different between patients with pCR and patients without pCR. The authors conclude that among patients with stage III melanoma, the combination of dabrafenib and trametinib resulted in low rates of recurrence-free survival.