ESMO 2017 | Combination targeted adjuvant therapy doubles relapse-free survival in stage III melanoma

Axel Hauschild

Combination targeted adjuvant therapy with dabrafenib and trametinib doubles relapse-free survival in patients with stage III BRAF-mutant melanoma, according to late-breaking results from the COMBI-AD trial presented today at the ESMO 2017 Congress in Madrid and published in the New England Journal of Medicine.

“There is no standard of care for the adjuvant treatment of stage III melanoma,” said the COMBI-AD presenter Axel Hauschild, Professor of Dermatology, University of Kiel, Kiel, Germany. “Interferon is approved for this situation but improves relative relapse-free survival by just 20% compared to placebo.”

COMBI-AD is the first clinical trial of targeted therapies for adjuvant treatment of stage III melanoma. All patients had a BRAF mutation – 91% harboured a V600E mutation and 9% had a V600K mutation, which is the typical distribution in clinical practice. Patients had lymph node metastases which had been completely excised. The primary endpoint of the trial was to prolong relapse-free survival.

The trial met its primary endpoint. At a median follow-up of 2.8 years, the combination therapy had significantly reduced the risk of disease recurrence or death by 53% compared to placebo (hazard ratio [HR], 0.47; 95% confidence interval, 0.39–0.58). The relapse-free survival benefit with the combination therapy was observed across all patient subgroups.

The combination treatment also showed a benefit in secondary endpoints including overall survival (HR, 0.57), distant metastases-free survival (HR, 0.51) and freedom from relapse (HR, 0.47).

“These are the best results ever shown for an adjuvant treatment in stage III melanomas,” said Hauschild. “Combination treatment with dabrafenib and trametinib more than doubled the relapse-free survival time compared to placebo and the improvement in overall survival was impressive, too.”

Watch the video for a presentation of the key results from Professor Hauschild.

This video was recorded at the ESMO 2017 Congress in Madrid, Spain

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