MDS 2023 | Safety and efficacy of ASTX727 in patients with CMML from Phase II and Phase III ASCERTAIN studies
Michael Savona, MD, Vanderbilt University Medical Center, Nashville, TN, discusses the safety and efficacy of ASTX727 in patients with chronic myelomonocytic leukemia (CMML) from Phase II (NCT02103478) and Phase III (NCT03306264) ASCERTAIN studies, highlighting the AMMO (ISRCTN30808508) and ABNL-MARRO 001 (NCT04061421) trial evaluating this agent alone or in different combinations. This interview took place at the 17th International Congress on Myelodysplastic Syndromes 2023 (MDS 2023) held in Marseille, France.
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Transcript (edited for clarity)
The results we presented here are combination of the Phase II and the Phase III study and we combine those studies knowing that’s not usually how you want to look at the data, but it’s a small number of patients. So we felt like we would be able to say something meaningful by combining those two data sets and the eligibility for the patients in both the Phase II and the Phase III ASCERTAIN study were relatively the same, the dosing and the regimen was the same and the design was very, very similar...
The results we presented here are combination of the Phase II and the Phase III study and we combine those studies knowing that’s not usually how you want to look at the data, but it’s a small number of patients. So we felt like we would be able to say something meaningful by combining those two data sets and the eligibility for the patients in both the Phase II and the Phase III ASCERTAIN study were relatively the same, the dosing and the regimen was the same and the design was very, very similar. So, it was a good opportunity to gather a historical bit of patients treated with [ASTX]727 and see how they did. We were quite pleased to see responses and about 80% of the patients with dysplastic-mild dysplastic CMML and good not quite as much but maybe 50 some percent response in the patients with proliferative CMML which was promising. But the really interesting thing was the survival curves and we were pleased with the survival at least versus historical controls in it, it deserves some follow up and there’s a lot of prospective work being done now with this agent in the AMMO study in Great Britain where Dan Wiseman and his colleagues are looking at ASTX727 as a single agent prospectively in CMML patients and that’s enrolling. Also ABNL-MARRO and ABNL-MARRO is an international collaboration for the MDS and MPN IWG. Our first study, ABNL-MARRO 001, has several arms that were randomly allocated that includes [ASTX]727 plus an additional drug. 001 arm A is [ASTX]727 plus itacitinib, which is a JAK inhibitor and that that arm is currently enrolling in the United States and about to open in France, Germany, Austria, Spain and Italy. Opening another arm of this study later this year which will open wider in Europe and in other countries in North America. So, we’re really excited about ABNL-MARRO and the promises that that brings to quickly test new therapies for patients with CMML and get hopefully drugs approved quickly.
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Disclosures
Karyopharm: Consultancy, Current equity holder in publicly-traded company, Membership on an entity’s Board of Directors or advisory committees; Ryvu: Consultancy, Current equity holder in publicly-traded company, Membership on an entity’s Board of Directors or advisory committees; Sierra Oncology: Other: serves on Data and Safety Monitoring Boards; TG Therapeutics: Research Funding; Incyte: Research Funding; Astex: Research Funding; Takeda: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Taiho: Membership on an entity’s Board of Directors or advisory committees; Novartis: Membership on an entity’s Board of Directors or advisory committees; Geron: Membership on an entity’s Board of Directors or advisory committees; AbbVie: Membership on an entity’s Board of Directors or advisory committees; Forma: Consultancy; BMS: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Other: serves on Data and Safety Monitoring Boards; ALX Oncology: Research Funding.
