ASH 2025 | Results of the ASC2ESCALATE trial of asciminib in CML-CP with one prior TKI
Jorge Cortes, MD, Georgia Cancer Center, Augusta University, Augusta, GA, discusses the results of the Phase II ASC2ESCALATE trial (NCT05384587) of asciminib in chronic myeloid leukemia in chronic phase (CML-CP) with one prior tyrosine kinase inhibitor (TKI). Dr Cortes highlights that the results suggest asciminib adds value as a second-line therapy, with a favorable safety profile. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
This abstract is reporting the results on the study that’s called the ASC2ESCALATE. The study has two arms. One of them is for patients that receive frontline therapy with asciminib that is not reported in this abstract, that’s reported separately. And the other one is patients that have received one prior tyrosine kinase inhibitor as frontline, could have been imatinib, could have been any of the second generation TKIs...
This abstract is reporting the results on the study that’s called the ASC2ESCALATE. The study has two arms. One of them is for patients that receive frontline therapy with asciminib that is not reported in this abstract, that’s reported separately. And the other one is patients that have received one prior tyrosine kinase inhibitor as frontline, could have been imatinib, could have been any of the second generation TKIs. The other element that’s important in this study is that patients that don’t meet the required, the desired responses, the optimal responses at specific time points, they’re allowed to escalate the dose from the starting of 80 milligrams once daily, to 200 milligrams once daily, and even 200 milligrams twice daily. The primary endpoint was the rate of major molecular response. And what the study shows is that, and starting first with the rate of response at 1% or less, it’s about 80% in this study. Both are 48, and it’s maintained very similar, a little bit higher later on. And this is important because historically, for second-line therapy, most studies, for example, with second-generation TKI after imatinib, that level of response in about 40 to 50% of patients. Now that’s historical, so we need to confirm that, but it suggests that it adds value to that. And of course, the rates of major molecular response are nearly 40%. And if you take all the cumulative rate of response at the end of that time of the cutoff for this study, it’s 70%. So very good results. And with the safety profile, similar to what’s been reported in other studies for asciminib, a little bit of hypertension, that’s the only one that has more grade 3s, and it’s only about 12%. So overall, very good results for this second-line use of asciminib. That is an approved indication in the U.S. In some parts of the world, it’s going as well. But it’s important because many patients are going to be started on treatment with imatinib, with second-generation TKIs, and if they have resistance or intolerance, this provides a very valuable approach.
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