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ASH 2025 | An ongoing Phase II dose-optimization trial of pirtobrutinib in patients with CLL/SLL
Alexey Danilov, MD, PhD, City of Hope, Duarte, CA, discusses the ongoing Phase II dose-optimization trial (NCT06588478) of pirtobrutinib in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Prof. Danilov highlights the favorable safety profile of this non-covalent BTK inhibitor, which is being tested at multiple dose levels to determine the optimal dose for maintaining response. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
Pirtobrutinib, as you know, is getting quite a bit of publicity at this ASH annual meeting. There are two large randomized studies being presented, and pirtobrutinib was recently approved as a second-line therapy option for patients with CLL. Pirtobrutinib is a safe agent – it’s one of the safest and best-tolerated BTK inhibitors that we have. Of course, it’s a non-covalent BTK inhibitor, which makes it different from the covalent BTK inhibitors out there...
Pirtobrutinib, as you know, is getting quite a bit of publicity at this ASH annual meeting. There are two large randomized studies being presented, and pirtobrutinib was recently approved as a second-line therapy option for patients with CLL. Pirtobrutinib is a safe agent – it’s one of the safest and best-tolerated BTK inhibitors that we have. Of course, it’s a non-covalent BTK inhibitor, which makes it different from the covalent BTK inhibitors out there. In this particular study, what we are investigating is different dose levels of pirtobrutinib. And this is part of the FDA’s Project Optimus, which aims to investigate whether a previously reached dose of the drug is really necessary to maintain response. So, three different dose levels are being investigated. And the preliminary data suggests that responses are similar with those three different dose levels. And of course, 200 milligram daily is the current dose that has being approved, that has been approved. But nevertheless, we are looking at progression-free survival and other efficacy outcomes with different doses of Pirtobrutinib and we also compare safety. Again, even though safety with Pirtobrutinib is great, there is always room for improvement on anything we do. So I’m looking forward to the first results of this study in progress.
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