COMBI-AD: Dabrafenib plus trametinib in advanced melanoma

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Published: 11 Sep 2017
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Dr Axel Hauschild - University Hospital, Schleswig-Holstein, Germany

Dr Hauschild speaks with ecancer at the ESMO 2017 Congress in Madrid about the COMBI-AD trial looking into the use of dabrafenib plus trametinib for patients with high-risk, stage III, BRAF V600E/K–mutant melanoma without prior anticancer therapy. 

Dr Hauschild goes on to discuss the results stating that relapse-free survival benefit with dabrafenib plus trametinib was observed across all patient subgroups. Dabrafenib plus trametinib also improved secondary endpoints of overall survival, distant metastasis-free survival, freedom from relapse.

For more information watch the press conference here, or read our news coverage here.

ecancer's filming has been kindly supported by Amgen through the ECMS Foundation. ecancer is editorially independent and there is no influence over content.

Hello, my name is Axel Hauschild, I’m a Professor of Dermatology from the University of Kiel in Germany. I’m head of the clinical trials centre in this institution; I was involved in the COMBI-AD trial which I presented today. It’s a trial on a BRAF inhibitor which is called dabrafenib and a MEK inhibitor named trametinib, compared to placebo. There is a very high medical need in patients with fully resected stage 3 melanoma, namely skin and lymph node metastases, and we were happy for those patients who are carrying a V600 mutation, which is 40% of the population, to provide a new clinical trial option.

The trial showed a significant improvement of relapse free survival with a hazard ratio of 0.47 and it’s a remarkable result, the best we have ever shown in a placebo controlled trial in the adjuvant setting of metastatic melanoma. Furthermore it showed an overall survival improvement of 0.57. Therefore it’s leading to a long-term response and a consistent benefit over time.

This was going along with some toxicities. Those toxicities were exactly the same as for stage 4 disease where the drugs have already been approved so no new toxicities, the same magnitude of grade 3/4 toxicities. A little more treatment discontinuations with 26% as for stage 4 disease.

So I believe it’s a nice clinical trial which showed remarkable outcome and this should be considered as a new treatment option for those patients who are carrying a V600 mutation.