Long-Term Data Sustain Dabrafenib/Trametinib RFS Benefit in BRAF+ Melanoma

Source: OnLive, November 2018

Long-term follow-up from the COMBI-AD trial continued to show a significant relapse-free survival (RFS) advantage for patients with resected stage III BRAF-mutant melanoma treated with adjuvant dabrafenib (Tafinlar) plus trametinib (Mekinist).

Patients randomized to adjuvant dabrafenib plus trametinib had a 4-year relapse-free survival (RFS) rate of 54%, as compared with 38% for placebo-treated patients. A cure-rate analysis for RFS produced estimates of 54% for dabrafenib/trametinib and 37% for placebo, representing the proportion of patients expected to achieve long-term RFS, as reported at the 2018 ESMO Congress.

A biomarker analysis showed that MAP kinase gene alterations were not associated with outcome in the adjuvant setting but did suggest that a high tumor mutational burden (TMB) in association with high levels of interferon-gamma might be predictive of greater benefit.