iwCLL 2025 | The impact of ibrutinib dose intensity on clinical outcomes of patients with CLL: EVIdeNCE study

So the EVIdeNCE is a clinical trial which was conducted in Italy when I worked in Italy to be honest and this trial was an observational non-interventional study which involved patients with chronic lymphocytic leukemia either in first line or patients with relapsed/refractory disease who were treated with ibrutinib. So the first results were already published and they showed really that in terms of efficacy and safety, the results were very similar to those of clinical trials. 

We present here in this meeting, the International Workshop on CLL meeting, we present data on dose intensity. In other words, we tried to correlate the adherence to the treatment with the clinical outcomes. It was interesting that there were mostly patients, mainly elderly, patients who were medically unfit. In these patients, there was a reduction of the dose, so the adherence was lower. However, most patients were able to retain about 80% adherence at 90 days. And what we found is that the cut-off time at 90 days was critical for assessing the impact of adherence on the clinical outcome. So in other words, patients with high-risk disease, such as patients with TP53 mutation or patients with advanced clinical stage, in these patients, respect of adherence was critical for achieving a very good clinical outcome in terms of progression-free survival. In contrast, in patients who were older or medically unfit, a limited adherence to the therapy did not have an impact on the progression-free survival, so the general message is that at the end, a personalized therapy with Ibrutinib can be done when there are medical reasons that justify a reduction of the dose.

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