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.