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Long-Term Results With Dabrafenib Plus Trametinib in Metastatic Melanoma

By: Lauren Harrison, MS
Posted: Tuesday, June 18, 2019

The combination of the BRAF inhibitor dabrafenib plus the MEK inhibitor trametinib led to a long-term benefit in approximately one-third of patients with unresectable or metastatic melanoma and a BRAF V600E or BRAF V600K mutation. Caroline Robert, MD, PhD, of Paris-Sud-Paris-Saclay University in Villejuif, France, and colleagues published long-term pooled data from two different trials in The New England Journal of Medicine.

“Having a complete response to the combined treatment appears to be a strong and early predictor of prolonged benefit. However, no biomarkers are currently available to determine which patients who discontinue therapy are likely to have disease progression,” concluded the authors.

Both the COMBI-d and COMBI-v trials focused on patients treated with dabrafenib and trametinib in the first-line setting. The median follow-up in the two trials was 22 months. In total, 563 patients were assigned to receive this combination therapy.

After 4 years, the progression-free survival rate for patients receiving dabrafenib and trametinib was 21%, and it decreased to 19% at 5 years. The overall survival rate was 37% at 4 years, and it decreased to 34% at 5 years. A complete response to the treatment was seen in 19% of patients, and it was associated with improved long-term outcome. The overall survival for complete responders was 71% at 5 years.

Baseline factors such as better performance status, older age, female sex, BRAF V600E genotype, fewer than three organ sites with metastasis, and normal lactate dehydrogenase levels were associated with increased progression-free and overall survival. This association was even stronger with respect to factors associated with tumor kinetic features and disease burden.

Disclosure: The study authors’ disclosure information may be found at nejm.org.



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