Comment: Targeted therapy ivosidenib in cholangiocarcinoma

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Published: 30 Sep 2019
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Dr Angela Lamarca - The Christie NHS Foundation Trust, Manchester, UK

Dr Angela Lamarca comments on data from the ClarIDHy trial during a press conference at the 2019 ESMO congress.

This was a phase III trial evaluating the use of the targeted therapy ivosidenib for advanced cholangiocarcinoma patients with the isocitrate dehydrogenase 1 (IDH1) mutation.

Watch the press conference here.

Watch Prof Ghassan Abou-Alfa's interview with ecancer here.

Read more about the study here 

From my point of view these results are practice changing, mainly because this is the first randomised clinical trial exploring precision medicine in cholangiocarcinoma. As you have seen, those patients who had an IDH1 mutation were benefitting from ivosidenib mainly in the form of progression free survival which means that their cancer was for a longer period of time under control. I do appreciate that looking at the medians the benefit may not seem clinically meaningful but, from my point of view, this trial is practice changing and showing a benefit in progression free survival especially if we focus our attention in that percentage of patients who are free of progression after six and twelve months since the treatment was started. So we are having 20% of patients free of progression at twelve months and 30% of them at six months with zero patients in the placebo arm.

Finally, regarding the overall survival results, I think if we focus again our attention in the overall survival when adjusted for cross-over a benefit from six months to ten months is definitely clinically meaningful for patients with cholangiocarcinoma who unfortunately have a very poor prognosis.

I think moving a step forward, it’s very important that we try and make sure that all our patients have access to molecular profiling which at the moment is a challenge in some of the countries. So that’s one of the homeworks that we get from this ESMO 2019.