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ASH 2025 | Preliminary results with the LSD1 inhibitor iadademstat combined with aza-ven in newly diagnosed AML
Curtis Lachowiez, MD, Oregon Health & Science University, Portland, OR, discusses the preliminary safety and efficacy results of a Phase Ib trial (NCT06357182) investigating the LSD1 inhibitor iadademstat in combination with azacitidine and venetoclax (aza-ven) in patients with newly diagnosed acute myeloid leukemia (AML). Dr Lachowiez notes that the study aims to determine if the triplet therapy can further improve outcomes, building on previous studies demonstrating activity of iadademstat with azacitidine and as monotherapy, and highlights the encouraging early findings. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
This is a phase 1b study that we’ve put together based on preclinical data that shows the combination of an LSD1 inhibitor, in this case, iadademstat from Oryzon. It shows a lot of preclinical synergy with venetoclax. There are other studies of LSD1 inhibitors specifically with Iadademstat as monotherapy in relapsed/refractory AML, where it showed some activity...
This is a phase 1b study that we’ve put together based on preclinical data that shows the combination of an LSD1 inhibitor, in this case, iadademstat from Oryzon. It shows a lot of preclinical synergy with venetoclax. There are other studies of LSD1 inhibitors specifically with Iadademstat as monotherapy in relapsed/refractory AML, where it showed some activity. And then in the Phase II ALICE study that was actually previously published iadademstat in combination with azacitidine, where a fairly respectable composite CR rate in the 50% to 60% range was observed, which was not quite as high as what we would expect with azacitidine and venetoclax with a composite CR-CRi rate of around 66.7%.
So this trial is addressing the question of, you know, we see activity of iadademstat with AZA, we see activity as monotherapy, but can the triplet therapy actually further improve outcomes? And so this is a phase 1b study investigating the combination of Iadademstat with azacitidine and venetoclax in patients with newly diagnosed AML that are adverse or intermediate risk using the ELN 2022 risk stratification criteria. So far, we have enrolled 10 patients on study. We’ve actually enrolled 12 to date. There are 10 patients in the presentation.
And we’ve seen very nice response rates. We’ve seen 100% overall response rate. We have a true CR rate of 90%, which is very encouraging when we think that these are true CRs, this is not a composite CR rate. And fortunately, we’ve seen a very tolerable safety profile. We haven’t had any… we have had one dose-limiting toxicity, which was an infectious event in a patient who was still going through their first cycle of therapy. But other than that, one event, we haven’t had any other dose-limiting toxicities. And we continue to accrue up to 21 patients at the higher iadademstat dosing. So we explored 100 micrograms of Iadademstat in dose level one, compared to 150 in dose level two, and that’s the cohort where we continue to accrue patients on, and follow-up is ongoing. It’s a little too early to discuss the survival outcomes of this patient population. The median follow-up is still less than a year, so I think that data is eagerly anticipated as we continue to enroll patients on the study.
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