EADO Congress 2015

The Co-BRIM study: Quality-of-life assessment in patients with metastatic melanoma

Prof Brigitte Dreno - Nantes University Hospital, Nantes, France

You were looking at vemurafenib plus cobimetinib; can you tell me about the Co-BRIM study, what it is you did and what you found?

Sure. In the Co-BRIM trial we compared the combination of anti-BRAF and anti-MEK, vemurafenib and cobimetinib, with vemurafenib alone. I presented very recent data from January 2015 confirming that we have a very important percentage of good results with more than 60% of complete and partial remissions and another important thing is that we increased to 16% of complete remissions. So definitively it showed that the combination has better results than using vemurafenib alone with a prolonged duration of response.

Is there a downside, though, in terms of toxicity from using this combination?

Yes, the problem of adverse events is an important question and we had first an increase of toxicity. The second thing is that we had several retinopathies but the opposite, we have a decrease of squamous cell carcinoma.

What’s your verdict, then, on using this combination of targeted therapies? Is it now to be recommended?

Not because we need to have the approval of our agency but I think that probably in the future it will be discussed as first line probably in patients with BRAF mutations.

How does this fit in with the first line therapy with immunotherapy, for example?

It can be discussed but I think that probably one of the most important things will be the speed, the rapidity of the evolution. When you have a quick evolution, BRAF positive, probably the Co-BRIM has to be firstly discussed. But you are perfectly right, the place of anti-PD1 can also be discussed but probably less in patients with a high tumour burden or a very quick evolution probably Co-BRIM will be most interesting in first line.

So could you sum up for busy cancer doctors what are the clinical messages, briefly, coming out of your study?

For patients who are BRAF positive it’s the future so we probably have to discuss first line the use of Co-BRIM with longer duration of responses and more complete remissions. So just to check about adverse events, it is always a problem of the ratio of benefit-risk.

Of course, we’re still waiting for licensing in certain ways, aren’t we?

Absolutely. Probably in 2016.

So what do you think is the message for current practice? Is it watch this space or are there things you can apply now?

Just that now we can say that we have the manner with a combination therapy. So we have a manner to avoid the problem of the resistance that we have with MEK.