EHA 2019 | Venetoclax and ibrutinib for R/R CLL: analysis from the VIsion/HO141 trial
Here, Arnon Kater, PhD, from the University of Amsterdam, Amsterdam, Netherlands, presents updates of the Phase II HO141/VIsion trial (NCT03226301) looking at venetoclax in combination with ibrutinib for relapsed/ refractory chronic lymphocytic leukemia (CLL). This interview took place at the 24th Congress of the European Hematology Association (EHA) 2019, held in Amsterdam, Netherlands.
Transcript (edited for clarity)
Yesterday we presented data on the first internal analysis of division trial where we have studied 51 patients, and those 51 patients had reached the end of cycle nine. A division trial, to give you a short overview, is a trial for relapsed, refractory patients where we are actually, are the first ones I think, that studied the combination of venetoclax–
Yesterday we presented data on the first internal analysis of division trial where we have studied 51 patients, and those 51 patients had reached the end of cycle nine. A division trial, to give you a short overview, is a trial for relapsed, refractory patients where we are actually, are the first ones I think, that studied the combination of venetoclax–ibrutinib for 12 months of combined treatment at full dose. Then randomized patients are stopped if we can see, we can stop treatment, if they MRD negative, or they continue. Our randomization is one to two randomization. So, exactly this is the first trial that we look whether this combination treatments, you can at least stop ibrutinib, instead of give it until relapse. So far we have the data on the first nine cycles, mostly on safety and it does look that the safety actually is not anything else than expected, based on single agent treatments, where there is no combined toxicity – most of it was neutropenia, which is a known complication of venetoclax. But also as I have seen in immunotherapy trials is that this neutropenia does not result in overt infections. Only pretty mild and, and only 20% of grade three infections were reported. If you look to early efficacy, we see that at nine cycles, clinically at least, 96 of the patients has responded with 60% complete responses based on, not on statistics, but on clinic. If you look to early MRD data that we have from 49 patients until cycle 12, you see very different than venetoclax with rituximab for instance, like the MURANO trial. Here we see we have not yet reached the plateau, so MRD levels are going up. Now at 12 months we are at approximately 40 – 50%, and the question is if it will further rise. At month 15, patients will be either randomized for stopping or continuous treatments.
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