Novartis announces long-term, relapse-free survival benefit for high-risk, stage III melanoma patients treated with Tafinlar + Mekinist following surgery.

Novartis announced updated results from the landmark COMBI-AD clinical trial, demonstrating that treatment with Tafinlar (dabrafenib) and Mekinist (trametinib) following the surgical removal of melanoma offers a long-term and durable relapse-free survival (RFS) benefit to high-risk patients diagnosed with stage III, BRAF-mutation positive melanoma. Researchers reported that 52% (95% CI, 48%-58%) of patients treated with adjuvant Tafinlar + Mekinist were alive and relapse-free at five years . Among patients in the study’s placebo arm 36% (95% CI, 32%-41%) were alive and relapse-free at the time of this analysis, generally consistent with typical melanoma relapse-free survival rates seen among patients with resected stage III disease without treatment. Consistent RFS benefit was observed across all AJCC 7 stage III subgroups. Median RFS, or the length of time when 50% of patients are still alive and relapse-free, was not yet reached at the 5-year data cut-off for patients on Tafinlar + Mekinist treatment, suggesting long-term benefit of targeted therapy in the adjuvant (post-surgical) setting (NR; 95% CI, 47.9 mo-NR)1. Median RFS was 16.6 months for patients taking a placebo (95% CI, 12.7-22.1 mo). Treatment with Tafinlar + Mekinist reduced the risk of relapse or death by 49% compared to placebo (hazard ratio [HR] 0.51; 95% CI 0.42, 0.61).. The COMBI-AD study results are drawn from a prospective analysis of 870 patients with BRAF V600-mutated melanoma treated with Tafinlar + Mekinist after their surgery.This study represents the largest collection of data and longest follow-up to date in this patient population treated with targeted therapy. The findings were presented at the ASCO20 Virtual Scientific Program (Abstract #10001).